A Phase 2 interventional study of Moderna mRNA-1273 and BNT162b2 in Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE) and Pemphigus Vulgaris, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Terminated at 29 sites in United States. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Prevention
This is a randomized, multi-site, adaptive, open-label clinical trial comparing the immune response to different additional doses of COVID-19 vaccine in participants with autoimmune disease requiring IS medications. All study participants will have negative serologic or suboptimal responses (defined as a Roche Elecsys® Anti-SARS-CoV-2 S result ≤200 U/mL) or a low immune response (defined as a Roche Elecsys® Anti-SARS-CoV-2 S result >200 U/ml and ≤2500 U/mL) to their previous doses of COVID-19 vaccine.
The study will focus on 5 autoimmune diseases in adults:
This study will focus on 4 autoimmune diseases in pediatric participants:
Adult Population:
Stage 1 of this trial will enroll up to a maximum of 900 adult study participants (up to 60 participants per arm).
Participants will be assigned to one of 3 cohorts based on their IS regimens:
Treatment Arms: Participants in Cohorts A, B, and C will be assigned to receive an additional dose of the same COVID-19 vaccine as their original vaccine series. The trial initially enrolled participants who were vaccinated with the Pfizer-BioNTech COVID-19 Vaccine, the Moderna COVID-19 Vaccine, and the Janssen COVID-19 Vaccine. Update: Arms to receive an additional homologous vaccine dose after an initial Janssen COVID 19 Vaccine were closed to enrollment after the CDC updated its recommendations to express a clinical preference for individuals to receive an mRNA COVID-19 vaccine over the Janssen COVID-19 vaccine. All Adult Stage 1 treatment arms were closed to enrollment on 15 August 2022.
Participants in Cohorts A and B will be randomized into 2 IS medication treatment plans as follows:
A participant will be enrolled in the study for a maximum of approximately 13 months.
Stage 2 of this trial will include up to a maximum of 960 adult study participants (up to 80per arm) with a Roche Elecsys® Anti-SARS-CoV-2 S result ≤2500 U/mL after previous COVID-19 vaccine administration (at least 3 doses of mRNA vaccine(s) or 2 doses of the Janssen COVID-19 Vaccine). Participants will be eligible to receive a dose of an alternative COVID-19 vaccine.
Participants may have received their previous COVID-19 vaccine prior to enrollment in the study ("newly recruited participant"), or they may have received their previous COVID-19 vaccine as a study participant and then (re-) enter into Stage 2 ("rollover participant"). Participants can also roll over into Stage 2 via two pathways:
Participants will be allocated to 1 of 3 cohorts based on their IS regimens:
Treatment Arms: Participants in Cohorts D, E, and F will receive a dose of an alternative COVID-19 vaccine compared to their previous COVID-19 vaccine doses. Originally, participants who previously received 3 total doses of a single mRNA vaccine (Moderna COVID-19 Vaccine OR Pfizer- BioNTech COVID-19 Vaccine) received their choice of either the Janssen vector-based COVID-19 vaccine or the other mRNA COVID-19 vaccine, and participants who previously received 2 doses of the Janssen vector based COVID-19 vaccine received the Moderna COVID-19 Vaccine.
Update: Beginning with v4.0 of the protocol, this trial will not utilize the Janssen vector-based COVID-19 vaccine. Participants who previously received 3 total doses of a single mRNA vaccine will receive their choice of an alternative mRNA COVID-19 vaccine or the Sanofi-GSK protein based COVID-19 vaccine. Participants who previously received 4 or more doses of a single mRNA vaccine or 3 or more doses of a mixture mRNA vaccines (Moderna COVID-19 Vaccine AND Pfizer-BioNTech COVID-19 Vaccine, in any order or combination) will receive the Sanofi-GSK protein-based COVID-19 vaccine.
Participants in Cohorts D and E will withhold their cohort-defining IS medications before and after the alternative vaccine dose per protocol instructions. Participants in Cohort F who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications before and after the alternative vaccine dose per protocol instructions.
Visits to assess endpoints will occur at Baseline (Week 0), Week 4 ± 1 week, Week 12 ± 2 weeks, Week 24 ± 2 weeks, Week 36 ± 2 weeks, and Week 48 ± 2 weeks. A participant who is newly recruited to the study for entry into Stage 2 may be on study for up to a maximum of 13 months. A participant who enters Stage 2 after a serologic negative, suboptimal, or low immune response to their Stage 1 vaccine dose may be on study for up to a maximum of 26 months. Rollover participants will discontinue follow-up as part of Stage 1 upon rollover into Stage 2. A participant who rolls over to a different Stage 2 treatment arm 2 after a serologic negative, suboptimal, or low immune response to another Stage 2 vaccine dose may be on study for up to a maximum of 38 months.
Pediatric Population:
Stage 1 in the pediatric portion of this trial will enroll up to a maximum of 800 participants (2-17 years of age) with a Roche Elecsys® Anti-SARS-CoV-2 S result ≤2500 U/mL after receiving an initial COVID-19 vaccine regimen (up to 80participants per arm). Vaccines will be included in this protocol as they receive EUA or approval by FDA for a given age group. Pediatric participants will have 1 of 4 autoimmune diseases: pediatric SLE, juvenile idiopathic arthritis (JIA), juvenile dermatomyositis (JDM), or pediatriconset multiple sclerosis (POMS). Participants will be assigned to 1 of 3 cohorts based on their IS regimens:
Treatment Arms: Participants in Cohorts A, B, and C will be assigned to receive an additional dose of the same vaccine as their original vaccine series. Based on FDA EUA status, pediatric participants were initially eligible to receive the Pfizer-BioNTech COVID-19 Vaccine only.
Participants in Cohorts A and B will be randomized into 2 IS medication treatment plans as follows):
A participant will be enrolled in the study for a maximum of approximately 13 months.
Stage 2 of the pediatric portion of this trial will include up to a maximum of 480 pediatric study participants (up to 80 per arm) with a Roche Elecsys® Anti-SARS-CoV-2 S result ≤2500 U/mL after previous COVID-19 vaccine administration (an age-appropriate EUA-authorized or FDA-approved initial COVID-19 vaccine regimen plus 1 additional dose of the same vaccine). All participants (2-17 years of age) who previously received doses of the Pfizer-BioNTech COVID-19 Vaccine are eligible to receive an age-appropriate dose of the Moderna COVID-19 Vaccine. Participants 12 through 17 years of age who previously received doses of the Moderna COVID-19 vaccine are eligible to receive an age-appropriate dose of the Pfizer-BioNTech COVID-19 Vaccine. Participants will be eligible to receive a dose of an alternative COVID-19 vaccine. Participants may have received their previous COVID-19 vaccine as a study participant and then enter into Stage 2 ("rollover participant"), or they may have received their previous COVID-19 vaccine prior to enrollment in the study ("newly recruited participant").
Participants will be allocated to 1 of 3 cohorts based on their IS regimens:
Cohort D: Receipt of MMF or MPA (± other rheumatic disease medications, including biologics)
o Participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) will be placed in this cohort.
Cohort E: Receipt of MTX (± other rheumatic disease medications, including biologics)
o Participants who are taking MTX (without additional B cell depleting medications or MMF/ MPA) will be placed in this cohort.
Treatment Arms: Participants in Cohorts D, E, and F will receive a dose of an alternative COVID-19 vaccine compared to their previous COVID-19 vaccine doses. Participants who previously received age-appropriate doses of a single mRNA vaccine (Moderna COVID-19 Vaccine OR Pfizer-BioNTech COVID-19 Vaccine, as noted above) will receive the other mRNA COVID-19 vaccine.
Beginning with v7.0 of the protocol all vaccines used are bivalent versions replacing original monovalent versions.
Participants in Cohorts D and E will withhold their cohort-defining IS medications before and after the alternative vaccine dose per protocol instructions (see Section 7.1.1 Protocol-mandated Medications).
Participants in Cohort F who are taking MMF, MPA, or MTX in addition to B cell depletion therapies (BCDTs) will withhold these medications before and after the alternative vaccine dose per protocol instruction.
A participant who enters Stage 2 after a serologic negative, suboptimal, or low immune response to their Stage 1 vaccine dose may be on study for up to a maximum of 26 months. Rollover participants will discontinue follow-up as part of Stage 1 upon rollover into Stage 2. A participant who is newly recruited to the study for entry into Stage 2 may be on study for up to a maximum of 13 months.
Adaptive Design
An adaptive design will be employed such that cohorts and arms defined by additional vaccine doses and IS treatment plans may be added or modified based on emerging data from existing and new FDA Emergency Use Authorization (EUA) or approvals of COVID-19 vaccines:
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's enrollment of 258 is above the median of 96 across 2,220 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
General Adult Inclusion Criteria:
1. Willing and able to sign 2. Documented full COVID-19 vaccination (CDC card or documentation in medical records) that was completed at least 4 weeks prior and no more than 52 weeks prior to the Stage 1 Screening visit, or if participating in Stage 2, no more than 48 weeks prior to the Stage 2 Screening visit.
General Exclusion Criteria 2. History of severe allergic reaction to the initial COVID-19 vaccine regimen, to any component of any of the COVID-19 vaccines, or to polyethylene glycol (PEG).
3. New diagnosis of that will require chemotherapy or immunotherapy, or ongoing treatment for a malignancy with chemotherapy or immunotherapy.
4. Active disease (per the Investigator's decision) resulting in inability to hold the IS therapy in the MMF/MPA or MTX arms of the study.
a. The potential impact of temporarily holding medication for participants with a recent mild disease flare within 4 weeks should be carefully considered.
5. Active disease during the Screening period resulting in:
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Positive result on a molecular COVID-19 test at Screening. 8. Inflammatory myocarditis/pericarditis within 6 weeks of any COVID-19 vaccine doses.
9. Participants with active, ongoing chronic infections. Note: Participants are permitted to be on chronic prophylactic antimicrobial therapy. Adults with evidence of , indicated by surface antigen, and indicated by anti-hepatitis C antibody positivity will be excluded. If an adult is negative for Hepatitis C viral load at Screening, he/she will be eligible to participate.
10. Participants with common variable immunodeficiency disease, as well as any participants currently receiving immune globulin replacement therapy. Note: Pediatric participants on IVIG therapeutically may enter the study provided they have sufficiently quiet disease that they can withhold their IVIG from 8 weeks prior to the Screening visit through 4 weeks after vaccination.
11. Participants who received licensed or monoclonal antibodies or plasma products directed against SARS-CoV-2 within 30 days of Screening.
12. Participants who have received any within 2 months of the anticipated study vaccine dose or who will have need of a live vaccine at any time during the study.
13. Currently pregnant or breastfeeding (For pediatric participants postmenarchal females must have a negative urine pregnancy test at Screening).
15. (Hgb) \<8.0 g/dL (80 g/L) 16. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
17. Other investigational chemical agent within 30 days or other investigational biologic agent within 8 weeks or 5 half-lives (whichever is longer) of Screening.
18. Concurrent treatment with cyclophosphamide. Adult participants taking cladribine, alemtuzumab, or mitoxantrone will also be excluded.
19. Participants currently on any type of dialysis, or who have received a solid organ transplant.
20. Prisoners or participants who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
21. Taking both MMF/MPA and MTX. 22. Receiving other investigational BCDT as part of a clinical trial within 18 months of Screening, unless drug assignment is known and the participant received an anti-CD20 or CD19 drug.
23. Participants with active systemic infections who have received systemic antimicrobials within the 14 days prior to Screening.
Adult General Criteria
Inclusion Criteria:
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If enrolling in the BCDT cohort, the participant must have received an anti-CD20 or an anti-CD19 BCDT in the past 18 months.
7. No changes in background IS medications, including MMF/MPA or MTX, in the 4 weeks prior to Screening, excluding the following:
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Corticosteroid bursts for non-autoimmune disease-related conditions, such as asthma or , are permitted.
Adult General Exclusion Criterion 1. Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
14. Adult female participants who are planning a pregnancy during the course of the trial.
Adult Stage 1-Specific Inclusion Criterion 5. Negative or suboptimal serologic response to initial COVID-19 vaccine regimen, defined as an Elecsys® Anti-SARS-CoV-2 S result ≤200 U/mL, at Screening visit.
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i.2 doses of the Pfizer-BioNTech COVID-19 Vaccine ii. 2 doses of the Moderna COVID-19 Vaccine
Adult Stage 1-Specific Exclusion Criterion 7. Receipt of a COVID-19 vaccine booster prior to Screening with the Moderna COVID-19 Vaccine, Pfizer-BioNTech COVID-19 Vaccine, or Janssen COVID-19 Vaccine.
Adult Stage 2 (Newly Recruited)-Specific Inclusion Criteria 2. History of severe allergic reaction to the COVID-19 vaccine, or to any component of the COVID-19 vaccine, that is to be administered in Stage 2, including polysorbate for participants receiving the Sanofi-GSK COVID-19 Vaccine, or to PEG.
5. Negative or suboptimal serologic response to a previous COVID 19 vaccine administration in one of the qualifying regimens, defined as an Elecsys® Anti-SARS-CoV-2 S (RBD) negative result or positive result of ≤200 U/mL, or a low immune response, defined as an Elecsys® Anti-SARS-CoV-2 S (RBD) result of ≤2500 U/mL, within 4 weeks of the Stage 2 Baseline/Week 0 visit. The regimens of COVID-19 vaccination that qualify are as follows:
Adult Stage 2 (Newly Recruited)-Specific Exclusion Criteria:
7. Receipt of a mixture of Janssen COVID-19 vaccines and mRNA COVID-19 vaccines (in any order or combination) prior to Stage 2 Screening.
Adult Stage 2 (Rollover)-Specific Inclusion Criteria:
Individuals who were previously enrolled in Adult Stage 1 or Adult Stage 2 will have met some inclusion and exclusion criteria at that time. Only a subset of the criteria for (re-)entering Adult Stage 2 will be assessed in rollover participants at the time of screening for Stage 2.
Individuals who meet all of the following criteria are eligible to (re )enter Adult Stage 2:
2. History of severe allergic reaction to the COVID-19 vaccine, or to any component of the COVID-19 vaccine, that is to be administered in Stage 2, including polysorbate for participants receiving the Sanofi-GSK COVID-19 Vaccine, or to PEG.
5. Negative or suboptimal serologic response to a previous COVID 19 vaccine administration in one of the qualifying regimens, defined as an Elecsys® Anti-SARS-CoV-2 S (RBD) negative result or positive result of ≤200 U/mL, or a low immune response, defined as an Elecsys® Anti-SARS-CoV-2 S (RBD) result of ≤2500 U/mL, within 4 weeks of the Stage 2 Baseline/Week 0 visit. The regimens of COVID-19 vaccination that qualify are as follows:
a. 3 doses of the Pfizer-BioNTech COVID-19 Vaccine b. 3 doses of the Moderna COVID-19 Vaccine c. 2 doses of the Janssen COVID-19 Vaccine d. 4 doses of a combination of mRNA vaccines (i.e., Pfizer-BioNTech COVID-19 Vaccine, Moderna COVID-19 Vaccine)
General Pediatric Inclusion Criteria
Individuals 2-17 years of age that meet classification criteria for SLE, JIA, POMS, or JDM. Note: Juvenile idiopathic arthritis includes the following conditions: polyarticular JIA (both RF + and -), oligoarticular persistent and oligoarticular extended JIA, psoriatic arthritis, and enthesitis related JIA.
5. Must be currently taking one of the following IS medications with or without additional disease-related medications: MMF (minimum of 250 mg per day)/MPA (minimum of 360 mg per day), MTX (minimum of 5 mg per week), or B cell depleting agents within the past 18 months (such as rituximab, ocrelizumab, or ofatumumab).
If enrolling in the BCDT cohort, participant must have received an anti-CD20 or an anti-CD19 BCDT in the past 18 months.
6. No changes in background IS medications, including MMF/MPA or MTX, in the 8 weeks prior to Screening, excluding the following:
a. HCQ, b. Intraarticular steroids, c. The addition of prednisone at \<0.15mg/kg/dose per day or prednisone at any dose when given for ≤3 days, and d. Corticosteroid bursts for non-autoimmune disease-related conditions, such as asthma or COPD, are permitted
General Pediatric Exclusion Criteria 1. Inability or unwillingness of a participant to give assent or of a parent/guardian to give written informed consent, or of either to comply with study protocol.
Pediatric Stage 1-Specific Inclusion Criteria:
4. Negative or suboptimal serologic response to initial EUA-authorized or FDA-approved COVID-19 vaccine doses, defined as an Elecsys® Anti-SARS-CoV-2 S result ≤200 U/mL, or a low immune response, defined as an Elecsys® Anti-SARS-CoV-2 S (RBD) result of ≤2500 U/mL, within 4 weeks of the Stage 1 Baseline/Week 0 visit
Initial COVID-19 vaccine regimen is defined as:
i. Pfizer-BioNTech COVID-19 Vaccine (2 through 4 years of age): 3 age-appropriate doses ii. Pfizer-BioNTech COVID-19 Vaccine (5 through 17 years of age): 2 age-appropriate doses iii. Moderna COVID-19 Vaccine (2 through 17 years of age): 2 age-appropriate doses.
Pediatric Stage 1-Specific Exclusion Criteria:
Individuals who meet any of these criteria are not eligible for randomization/allocation as participants in the pediatric portion of the study:
7. Receipt of a COVID-19 vaccine booster prior to Screening.
Pediatric Stage 2 (Newly Recruited)-Specific Inclusion Criteria 5. Negative or suboptimal serologic response to homologous doses of COVID-19 vaccine in one of the qualifying regimens, defined as an Elecsys® Anti-SARS-CoV-2 S (RBD) negative result or positive result of ≤200 U/mL, or a low immune response, defined as an Elecsys® Anti-SARS-CoV-2 S (RBD) result of ≤2500 U/mL, within 4 weeks of the Stage 2 Baseline/Week 0 visit. The regimens of COVID-19 vaccination that qualify are as follows: a. Pfizer-BioNTech COVID-19 Vaccine (2 through 5 years of age): 4 full, age-appropriate doses of the Pfizer-BioNTech COVID-19 Vaccine b. Pfizer-BioNTech COVID-19 Vaccine (5 through 17 years old): 3 full, age-appropriate doses of the Pfizer-BioNTech COVID-19 Vaccine Note: Participants who are 5 years old and previously received the Pfizer-BioNTech COVID-19 Vaccine may have received either age-appropriate regimen.
c. Moderna COVID-19 Vaccine (12 through 17 years of age): 3 full, age-appropriate doses of the Moderna COVID-19 Vaccine
Pediatric Stage 2 (Newly Recruited)-Specific Exclusion Criteria:
7. Receipt of an additional heterologous COVID-19 vaccine dose prior to Stage 2 Screening, i.e., a participant cannot have received a mixture of mRNA vaccines.
Pediatric Stage 2 (Rollover)-Specific Inclusion Criteria:
5. Negative or suboptimal serologic response to a previous COVID-19 vaccine administration in one of the qualifying regimens, defined as an Elecsys® Anti-SARS-CoV-2 S (RBD) negative result or positive result of ≤200 U/mL, or a low immune response, defined as an Elecsys® Anti-SARS-CoV-2 S (RBD) result of ≤2500 U/mL, within 4 weeks of the Stage 2 Baseline/Week 0 visit. The regimens of COVID-19 vaccination that qualify are as follows:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will receive an additional dose of the Moderna COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
Biological: Moderna mRNA-1273 · Drug: Continue IS (MMF or MPA)
Adult participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
Biological: BNT162b2 · Drug: Continue IS (MMF or MPA)
Arm closed, effective protocol version 3.0. Adult participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will receive the Janssen COVID-19 vaccine booster (1 dose) and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
Biological: Ad26.COV2.S · Drug: Continue IS (MMF or MPA)
Adult participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Moderna COVID-19 vaccine, per protocol instruction.
Biological: Moderna mRNA-1273 · Drug: Withhold IS (MMF or MPA)
Adult participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Pfizer-BioNTech COVID-19 vaccine, per protocol instruction.
Biological: BNT162b2 · Drug: Withhold IS (MMF or MPA)
Arm closed, effective protocol version 3.0. Adult participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after the Janssen COVID-19 vaccine booster (1 dose), per protocol instruction.
Biological: Ad26.COV2.S · Drug: Withhold IS (MMF or MPA)
Adult participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will receive an additional dose of the Moderna COVID-19 vaccine booster and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
Biological: Moderna mRNA-1273 · Drug: Continue IS (MTX)
Adult participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech COVID-19 vaccine booster and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
Biological: BNT162b2 · Drug: Continue IS (MTX)
Arm closed, effective protocol version 3.0. Adult participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will receive the Janssen COVID-19 vaccine booster (1 dose) and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
Biological: Ad26.COV2.S · Drug: Continue IS (MTX)
Adult Participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Moderna COVID-19 vaccine, per protocol instruction.
Biological: Moderna mRNA-1273 · Drug: Withhold IS (MTX)
Adult participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Pfizer-BioNTech COVID-19 vaccine booster, per protocol instruction.
Biological: BNT162b2 · Drug: Withhold IS (MTX)
Arm closed, effective protocol version 3.0. Adult participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after the Janssen COVID-19 vaccine booster (1 dose), per protocol instruction.
Biological: Ad26.COV2.S · Drug: Withhold IS (MTX)
Adult participants taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will receive an additional dose of the Moderna COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
Biological: Moderna mRNA-1273 · Biological: Continue IS (B cell depletion therapy)
Adult participants taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will receive an additional dose of the Pfizer-BioNTech COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
Biological: BNT162b2 · Biological: Continue IS (B cell depletion therapy)
Arm closed, effective protocol version 3.0. Adult participants taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will receive the Janssen COVID-19 vaccine booster (1 dose) and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
Biological: Ad26.COV2.S · Biological: Continue IS (B cell depletion therapy)
Arm closed, effective protocol version 4.0. Adult participants who previously received an mRNA vaccine and who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Janssen COVID-19 vaccine, per protocol instruction.
Biological: Ad26.COV2.S · Drug: Withhold IS (MMF or MPA)
Adult participants who previously received an mRNA vaccine and who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of an alternative COVID-19 vaccine, per protocol instruction. Beginning with version 6.0 of the protocol, bivalent versions of the mRNA vaccines, Moderna and Pfizer-BioNTech COVID-19 vaccines, replaced original monovalent versions.
Biological: BNT162b2 · Drug: Withhold IS (MMF or MPA) · Biological: Moderna mRNA-1273, Bivalent · Biological: BNT162b2, Bivalent
Adult participants who previously received the Janssen COVID-19 vaccine and who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Moderna COVID-19 vaccine, per protocol instruction. Beginning with version 6.0 of the protocol, bivalent versions of the mRNA vaccines, Moderna and Pfizer-BioNTech COVID-19 vaccines, replaced original monovalent versions.
Drug: Withhold IS (MMF or MPA) · Biological: Moderna mRNA-1273, Bivalent
Arm closed, effective protocol version 4.0. Adult participants who previously received an mRNA vaccine and who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Janssen COVID-19 vaccine, per protocol instruction.
Biological: Ad26.COV2.S · Drug: Withhold IS (MTX)
Adult participants who previously received an mRNA vaccine and who are taking methotrexate (without additional B cell depleting medications or MMF/MPA) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of an alternative COVID-19 vaccine, per protocol instruction. Beginning with version 6.0 of the protocol, bivalent versions of the mRNA vaccines, Moderna and Pfizer-BioNTech COVID-19 vaccines, replaced original monovalent versions.
Drug: Withhold IS (MTX) · Biological: Moderna mRNA-1273, Bivalent · Biological: BNT162b2, Bivalent
Adult participants who previously received the Janssen COVID-19 vaccine and who are taking methotrexate (without additional B cell depleting medications or MMF/MPA) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Moderna COVID-19 vaccine, per protocol instruction. Beginning with version 6.0 of the protocol, bivalent versions of the mRNA vaccines, Moderna and Pfizer-BioNTech COVID-19 vaccines, replaced original monovalent versions.
Drug: Withhold IS (MTX) · Biological: Moderna mRNA-1273, Bivalent
Arm closed, effective protocol version 4.0. Adult participants who previously received an mRNA vaccine and who are taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will continue to take their prescribed BCDTs without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX ) before and after receiving a dose of the Janssen COVID-19 vaccine, per protocol instruction.
Biological: Ad26.COV2.S · Drug: Withhold IS (B cell depletion therapy)
Adult participants who previously received an mRNA vaccine and who are taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will continue to take their prescribed BCDTs without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the alternative COVID-19 vaccine, per protocol instruction. Beginning with version 6.0 of the protocol, bivalent versions of the mRNA vaccines, Moderna and Pfizer-BioNTech COVID-19 vaccines, replaced original monovalent versions.
Drug: Withhold IS (B cell depletion therapy) · Biological: Moderna mRNA-1273, Bivalent · Biological: BNT162b2, Bivalent
Adult participants who previously received the Janssen COVID-19 vaccine and who are taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will continue to take their prescribed BCDTs without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the Moderna COVID-19 vaccine, per protocol instruction. Beginning with version 6.0 of the protocol, bivalent versions of the mRNA vaccines, Moderna and Pfizer-BioNTech COVID-19 vaccines, replaced original monovalent versions.
Drug: Withhold IS (B cell depletion therapy) · Biological: Moderna mRNA-1273, Bivalent
Adult participants who previously received an mRNA vaccine and who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Sanofi-GSK COVID-19 vaccine, per protocol instruction.
Biological: Monovalent [B.1.351] CoV2 preS dTM-AS03 · Drug: Withhold IS (MMF or MPA)
Adult participants who previously received an mRNA vaccine and who are taking methotrexate (without additional B cell depleting medications or MMF/MPA) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Sanofi-GSK COVID-19 vaccine, per protocol instruction.
Biological: Monovalent [B.1.351] CoV2 preS dTM-AS03 · Drug: Withhold IS (MTX)
Adult participants who previously received an mRNA vaccine and who are taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will continue to take their prescribed BCDTs without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the Sanofi-GSK COVID-19 vaccine, per protocol instruction
Biological: Monovalent [B.1.351] CoV2 preS dTM-AS03 · Drug: Withhold IS (B cell depletion therapy)
Pediatric participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will receive an additional dose of the Moderna COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
Drug: Continue IS (MMF or MPA) · Biological: Moderna mRNA-1273, Bivalent
Pediatric participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
Drug: Continue IS (MMF or MPA) · Biological: BNT162b2, Bivalent
Pediatric participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Moderna COVID-19 vaccine, per protocol instruction.
Drug: Withhold IS (MMF or MPA) · Biological: Moderna mRNA-1273, Bivalent
Pediatric participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Pfizer-BioNTech COVID-19 vaccine, per protocol instruction.
Drug: Withhold IS (MMF or MPA) · Biological: BNT162b2, Bivalent
Pediatric participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will receive an additional dose of the Moderna COVID-19 vaccine booster and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
Drug: Continue IS (MTX) · Biological: Moderna mRNA-1273, Bivalent
Pediatric participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech COVID-19 vaccine booster and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
Drug: Continue IS (MTX) · Biological: BNT162b2, Bivalent
Pediatric participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Moderna COVID-19 vaccine, per protocol instruction.
Drug: Withhold IS (MTX) · Biological: Moderna mRNA-1273, Bivalent
Pediatric participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Pfizer-BioNTech COVID-19 vaccine booster, per protocol instruction.
Drug: Withhold IS (MTX) · Biological: BNT162b2, Bivalent
Pediatric participants taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will receive an additional dose of the Moderna COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
Biological: Continue IS (B cell depletion therapy) · Biological: Moderna mRNA-1273, Bivalent
Pediatric participants taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will receive an additional dose of the Pfizer-BioNTech COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
Biological: Continue IS (B cell depletion therapy) · Biological: BNT162b2, Bivalent
Pediatric participants who previously received the Moderna COVID-19 vaccine and who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Pfizer-BioNTech COVID-19 vaccine, per protocol instruction.
Drug: Withhold IS (MMF or MPA) · Biological: BNT162b2, Bivalent
Pediatric participants who previously received the Pfizer-BioNTech COVID-19 vaccine and who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Moderna COVID-19 vaccine, per protocol instruction.
Drug: Withhold IS (MMF or MPA) · Biological: Moderna mRNA-1273, Bivalent
Pediatric participants who previously received the Moderna COVID-19 vaccine and who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Pfizer-BioNTech COVID-19 vaccine, per protocol instruction.
Drug: Withhold IS (MTX) · Biological: BNT162b2, Bivalent
Pediatric participants who previously received the Pfizer-BioNTech COVID-19 vaccine and who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Moderna COVID-19 vaccine, per protocol instruction.
Drug: Withhold IS (MTX) · Biological: Moderna mRNA-1273, Bivalent
Pediatric participants who previously received the Moderna COVID-19 vaccine and who are taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will continue to take their prescribed BCDTs without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the Pfizer-BioNTech COVID-19 vaccine, per protocol instruction.
Drug: Withhold IS (B cell depletion therapy) · Biological: BNT162b2, Bivalent
Pediatric participants who previously received the Pfizer-BioNTech COVID-19 vaccine and who are taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will continue to take their prescribed BCDTs without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the Moderna COVID-19 vaccine, per protocol instruction.
Drug: Withhold IS (B cell depletion therapy) · Biological: Moderna mRNA-1273, Bivalent
Administration: One dose administered intramuscularly.
Also known as: mRNA-1273 vaccine (Moderna), Moderna COVID-19 Vaccine, SARS-CoV-2 RNA vaccine, COVID-19 vaccine
Administration: One dose administered intramuscularly.
Also known as: mRNA-1273 vaccine (Pfizer/BioNTech), SARS-CoV-2 RNA vaccine, Pfizer-BioNTech COVID-19 vaccine
Administration: One dose administered intramuscularly.
Also known as: Janssen COVID-19 Vaccine, JNJ-78436735
Participants continue to take their immunosuppressive (IS) medications for management of their autoimmune disease without alterations in schedule and dosing.
Also known as: immunosuppressive medication, mycophenolate mofetil, MMF, CellCept®, mycophenolic acid, MPA
Participants continue to take their immunosuppressive (IS) medications for management of their autoimmune disease without alterations in schedule and dosing.
Also known as: methotrexate, MTX
Participants will continue to take their prescribed immunosuppressive (IS) medications without alterations in schedule and dosing.
Also known as: mAbs targeting CD19 or CD20, anti-BAFF mAb
One dose administered intramuscularly
Also known as: Sanofi-GSK COVID-19 Vaccine
Participants withhold their cohort-defining immunosuppressive (IS) medications for management of their autoimmune disease before and after the additional vaccine dose per protocol instructions.
Also known as: immunosuppressive medication, mycophenolate mofetil, MMF, CellCept®, mycophenolic acid, MPA
Participants withhold their cohort-defining immunosuppressive (IS) medications for management of their autoimmune disease before and after the additional vaccine dose per protocol instructions.
Also known as: methotrexate, MTX
Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX ) before and after the additional vaccine dose per protocol instructions. Participants will continue to take their prescribed BCDTs without alterations in schedule and dosing.
Also known as: mAbs targeting CD19 or CD20, anti-BAFF mAb
Administration: One dose administered intramuscularly.
Also known as: mRNA-1273 vaccine (Moderna), Bivalent, Moderna COVID-19 Vaccine, Bivalent, SARS-CoV-2 RNA vaccine, Bivalent, COVID-19 vaccine, Bivalent
Administration: One dose administered intramuscularly.
Also known as: mRNA-1273 vaccine (Pfizer/BioNTech), Bivalent, SARS-CoV-2 RNA vaccine, Bivalent, Pfizer-BioNTech COVID-19 vaccine, Bivalent
Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) 3 plex assay (Wu-1 full-length spike, receptor binding domain (RBD), and N proteins). A threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
Time frame: Week 4 Status Post Receipt of COVID-19 Vaccination
Percent of Stage 2 Adult Participants Who Have a Protective Antibody Response at Week 4
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) 3 plex assay (Wu-1 full-length spike, receptor binding domain (RBD), and N proteins). A threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
Time frame: Week 4 Status Post Receipt of COVID-19 Vaccination
Percent of Stage 2 Pediatric Participants Who Have a Protective Antibody Response at Week 4
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) 3 plex assay (Wu-1 full-length spike, receptor binding domain (RBD), and N proteins). A threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
Time frame: Week 4 Status Post Receipt of COVID-19 Vaccination
Percentage of Stage 1 Adult Participants Who Seroconverted
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center Meso Scale Discovery 3 plex assay. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or COVID-19 vaccine given off-study were excluded from the analyses. Participants missing antibody data were considered missing-completely-at-random. Seroconversion was assessed in the subgroup of participants who were anti-COVID-19 antibody negative at Week 0; defined as a result less than or equal to the positive threshold value (spike=10.8424, RBD=14.0858). Anti-COVID-19 antibody negative at Week 0 is defined separately for spike and RBD. Seroconversion was defined as having a result greater than the positive threshold at the Week 4 visit.
Time frame: Week 4 Status Post Receipt of COVID-19 Vaccination
Percentage of Stage 2 Adult Participants Who Seroconverted
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center Meso Scale Discovery 3 plex assay. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or COVID-19 vaccine given off-study were excluded from the analyses. Participants missing antibody data were considered missing-completely-at-random. Seroconversion was assessed in the subgroup of participants who were anti-COVID-19 antibody negative at Week 0; defined as a result less than or equal to the positive threshold value (spike=10.8424, RBD=14.0858). Anti-COVID-19 antibody negative at Week 0 is defined separately for spike and RBD. Seroconversion was defined as having a result greater than the positive threshold at the Week 4 visit.
Time frame: Week 4 Status Post Receipt of COVID-19 Vaccination
Fold Increase in Stage 1 Adult Anti-COVID-19 Antibody Levels
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center Meso Scale Discovery 3 plex assay. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing antibody data were considered missing-completely-at-random. Fold increase was assessed in the subgroup of participants who were anti-COVID-19 antibody positive at Week 0; defined as having a result greater than the positive threshold value (spike=10.8424, RBD=14.0858). Anti-COVID-19 antibody positive at Week 0 is defined separately for spike and RBD. Fold increase = (antibody response at Week 4)/(antibody response at Week 0).
Time frame: Week 4 Status Post Receipt of COVID-19 Vaccination
Fold Increase in Stage 2 Adult Anti-COVID-19 Antibody Levels
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center Meso Scale Discovery 3 plex assay. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing antibody data were considered missing-completely-at-random. Fold increase was assessed in the subgroup of participants who were anti-COVID-19 antibody positive at Week 0; defined as having a result greater than the positive threshold value (spike=10.8424, RBD=14.0858). Anti-COVID-19 antibody positive at Week 0 is defined separately for spike and RBD. Fold increase = (antibody response at Week 4)/(antibody response at Week 0).
Time frame: Week 4 Status Post Receipt of COVID-19 Vaccination
Change in Stage 1 Adult Anti-COVID-19 Antibody Response
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) 3 plex assay (Wu-1 full-length spike, receptor binding domain (RBD), and N proteins). Wu-1 full-length spike and RBD were used to assess vaccine response. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing anti-COVID-19 antibody response data were considered to be missing-completely-at-random.
Time frame: Week 0 and Weeks 4 and 12 Status Post Receipt of COVID-19 Vaccination
Change in Stage 2 Adult Anti-COVID-19 Antibody Response
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) 3 plex assay (Wu-1 full-length spike, receptor binding domain (RBD), and N proteins). Wu-1 full-length spike and RBD were used to assess vaccine response. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing anti-COVID-19 antibody response data were considered to be missing-completely-at-random.
Time frame: Week 0 and Weeks 4 and 12 Status Post Receipt of COVID-19 Vaccination
Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) V-Plex ACE2 neutralization assay which measure antibodies that block the binding of angiotensin-converting enzyme 2 (ACE2) to the SARS-CoV-2 Spike antigens, including variants of the SARS-CoV-2 virus according to the manufacturer's instruction (MSD Catalog # K15654U). Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing anti-COVID-19 antibody response data were considered to be missing-completely-at-random. Results are reported as fold inhibition by a sample relative to signal from a 'diluent only' control (maximum ACE2 binding to antigen). Highly neutralizing samples show high fold inhibition whereas negative or low samples show low fold inhibition of ACE2 binding.
Time frame: Week 0 and Weeks 4 and 12 Status Post Receipt of COVID-19 Vaccination
Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Adult Samples
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) V-Plex ACE2 neutralization assay which measure antibodies that block the binding of angiotensin-converting enzyme 2 (ACE2) to the SARS-CoV-2 Spike antigens, including variants of the SARS-CoV-2 virus according to the manufacturer's instruction (MSD Catalog # K15654U). Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing anti-COVID-19 antibody response data were considered to be missing-completely-at-random. Results are reported as fold inhibition by a sample relative to signal from a 'diluent only' control (maximum ACE2 binding to antigen). Highly neutralizing samples show high fold inhibition whereas negative or low samples show low fold inhibition of ACE2 binding.
Time frame: Week 0 and Weeks 4 and 12 Status Post Receipt of COVID-19 Vaccination
Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C)
The Clinical Global Impression of Change (CGI-C) is the clinician's global impression of a participant's clinical condition in terms of change relative to the start of treatment. Change is rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
Time frame: Weeks 4 Status Post Receipt of COVID-19 Vaccine Dose
Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C)
The Clinical Global Impression of Change (CGI-C) is the clinician's global impression of a participant's clinical condition in terms of change relative to the start of treatment. Change is rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
Time frame: Weeks 4 Status Post Receipt of COVID-19 Vaccine Dose
Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment
The Physician's Global Assessment of the participant's current disease activity is assessed on a 10 cm linear horizontal visual analog scale, where the left hand extreme of the line is considered "Very Good" (0 cm, no disease activity) and the right hand extreme is considered "Very Bad" (10 cm, severe disease activity).
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Change in Adult Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment
The Physician's Global Assessment of the participant's current disease activity is assessed on a 10 cm linear horizontal visual analog scale, where the left hand extreme of the line is considered "Very Good" (0 cm, no disease activity) and the right hand extreme is considered "Very Bad" (10 cm, severe disease activity).
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI)
The Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) is a validated, physician-based assessment tool used to measure the extent of lupus disease activity within the past 28 days. hSLEDAI total score is a weighted sum of the presence of 24 lupus disease symptoms and ranges from 0 to 105, with higher scores indicating more lupus disease activity present.
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Change in Disease Activity in Stage 2 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI)
The Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) is a validated, physician-based assessment tool used to measure the extent of lupus disease activity within the past 28 days. hSLEDAI total score is a weighted sum of the presence of 24 lupus disease symptoms and ranges from 0 to 105, with higher scores indicating more lupus disease activity present.
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index
The Thanou Modified Safety of Estrogens in Lupus Erythematosus: National Assessment- Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) assesses systemic lupus erythematosus (SLE) disease activity and categorizes mild/moderate or severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), other disease activity criteria, and hospitalization due to SLE. The hSLEDAI is a validated, physician-based assessment tool used to measure the extent of lupus disease activity within the past 28 days. hSLEDAI total score is a weighted sum of the presence of 24 lupus disease symptoms and ranges from 0 to 105, with higher scores indicating more lupus disease activity present.
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Change in Disease Activity in Stage 2 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index
The Thanou Modified Safety of Estrogens in Lupus Erythematosus: National Assessment- Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) assesses systemic lupus erythematosus (SLE) disease activity and categorizes mild/moderate or severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), other disease activity criteria, and hospitalization due to SLE. The hSLEDAI is a validated, physician-based assessment tool used to measure the extent of lupus disease activity within the past 28 days. hSLEDAI total score is a weighted sum of the presence of 24 lupus disease symptoms and ranges from 0 to 105, with higher scores indicating more lupus disease activity present.
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Change in Disease Activity in Stage 1 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP)
The Disease Activity Score 28 C-reactive Protein (DAS28-CRP) is: a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (\>5.1=high disease activity; \<=3.2=low disease activity; \<2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm). Reference: van Gestel AM et al. Arthritis Rheum.1998; 41(10): 1845-50.
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Change in Disease Activity in Stage 2 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP)
The Disease Activity Score 28 C-reactive Protein (DAS28-CRP) is: a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (\>5.1=high disease activity; \<=3.2=low disease activity; \<2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm). Reference: van Gestel AM et al. Arthritis Rheum.1998; 41(10): 1845-50.
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Change in Disease Activity in Stage 1 Adult Participants With Systemic Sclerosis (SSc) as Measured by Disease Flare Activity
Severe disease flare included onset of new or significant worsening of internal organ involvement requiring hospitalization or change in treatment. Internal organ involvement included scleroderma renal crisis, interstitial lung disease, left or right sided heart failure, pulmonary arterial hypertension on right-sided heart catheterization or other worsening of internal organs.
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Change in Disease Activity in Stage 2 Adult Participants With Systemic Sclerosis (SSc) as Measured by Disease Flare Activity
Severe disease flare included onset of new or significant worsening of internal organ involvement requiring hospitalization or change in treatment. Internal organ involvement included scleroderma renal crisis, interstitial lung disease, left or right sided heart failure, pulmonary arterial hypertension on right-sided heart catheterization or other worsening of internal organs.
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Change in Disease Activity in Stage 1 Adult Participants With Pemphigus as Measured by Disease Area Index (PDAI) for Pemphigus
The Pemphigus Disease Area Index (PDAI) was developed by the International Pemphigus Committee and measures both activity of and damage due to pemphigus on the skin, scalp, and mucous membranes. Total scores can range from 0 to a possible 263 maximum score, with 250 points representing disease activity (120 points for skin activity, 10 points for scalp activity, and 120 points for mucosal activity) and 13 points representing disease damage. Higher scores reflect worse disease.
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Change in Disease Activity in Stage 2 Adult Participants With Pemphigus as Measured by Disease Area Index (PDAI) for Pemphigus
The Pemphigus Disease Area Index (PDAI) was developed by the International Pemphigus Committee and measures both activity of and damage due to pemphigus on the skin, scalp, and mucous membranes. Total scores can range from 0 to a possible 263 maximum score, with 250 points representing disease activity (120 points for skin activity, 10 points for scalp activity, and 120 points for mucosal activity) and 13 points representing disease damage. Higher scores reflect worse disease.
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Change in Disease Activity in Stage 1 Adult Participants With Multiple Sclerosis (MS) as Measured by Physician Assessed Relapse for MS
Relapse required: either criteria (a) with investigator determination of relapse or criteria (a) and (b): (a) New, recurrent or worsening neurological symptoms attributable to MS, that meet all of the following: i. Appeared or evolved subacutely (over \<3 months). ii. Persisting \>24 hours. iii. Can't be attributed to confounding factors. iv. Occur ≥30 days after onset of a prior confirmed relapse. (b) New, recurrent or worsening neurological symptoms accompanied by corresponding objective worsening on neurologic examination with an increase of any one of the following compared to the immediate prior assessment: i. ≥0.5 step(s) on the Expanded Disability Status Scale (EDSS), ii. ≥2 points on one Functional Systems Score (FSS), iii. ≥1 point on two or more FSS. Episodic spasms, sexual dysfunction, fatigue, mood change, or bladder/bowel urgency or incontinence will not suffice to establish relapse. Sexual dysfunction and fatigue will not contribute to the EDSS/FSS for assessing relapse.
Time frame: Screening and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Change in Disease Activity in Stage 2 Adult Participants With Multiple Sclerosis (MS) as Measured by Physician Assessed Relapse for MS
Relapse required: either criteria (a) with investigator determination of relapse or criteria (a) and (b): (a) New, recurrent or worsening neurological symptoms attributable to MS, that meet all of the following: i. Appeared or evolved subacutely (over \<3 months). ii. Persisting \>24 hours. iii. Can't be attributed to confounding factors. iv. Occur ≥30 days after onset of a prior confirmed relapse. (b) New, recurrent or worsening neurological symptoms accompanied by corresponding objective worsening on neurologic examination with an increase of any one of the following compared to the immediate prior assessment: i. ≥0.5 step(s) on the Expanded Disability Status Scale (EDSS), ii. ≥2 points on one Functional Systems Score (FSS), iii. ≥1 point on two or more FSS. Episodic spasms, sexual dysfunction, fatigue, mood change, or bladder/bowel urgency or incontinence will not suffice to establish relapse. Sexual dysfunction and fatigue will not contribute to the EDSS/FSS for assessing relapse.
Time frame: Screening and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Change in Disease Activity in Stage 2 Pediatric Participants With Juvenile Idiopathic Arthritis (JIA) as Measured by the Juvenile Arthritis Disease Activity Score 10 (JADAS10)
The Juvenile Arthritis Disease Activity Score 10-C-reactive Protein (JADAS10-CRP) is a score on a scale (0 to 40) indicating activity of juvenile idiopathic arthritis. Total active joints are scored 0 to 10, with an active joint count \>10 scored as 10 points. The Physician's Global Assessment and Patient's Global Assessment are measured on a 0-10 scale (0 cm, no disease activity to 10 cm, worst disease activity). CRP is normalized to a 0 to 10 scale according to the following formula: (CRP (mg/L) - 10)/10. CRP values \<10 mg/L are scored as 0, and CRP \>110 mg/L are scored as 10. The final score is given by the simple sum of its component. Higher scores indicate worse disease activity.
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29)
The Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Short Form (Version 2.0) will be used to assess trends over time in this state of health measure. The PROMIS-29 consists of 7 domains related to physical, mental and social health. Raw scores are calculated for each domain and translated into a T-score per the PROMIS-29 scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. Physical Function domain score is presented. A higher score represents better functioning for the Physical Function domain.
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Change in Adult Stage 2 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29)
The Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Short Form (Version 2.0) will be used to assess trends over time in this state of health measure. The PROMIS-29 consists of 7 domains related to physical, mental and social health. Raw scores are calculated for each domain and translated into a T-score per the PROMIS-29 scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. Physical Function domain score is presented. A higher score represents better functioning for the Physical Function domain.
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment
The Patient Global Assessment of the participant's current disease activity is assessed on a 10 cm linear horizontal visual analog scale, where the left hand extreme of the line is considered "Very Good" (0 cm, no disease activity) and the right hand extreme is considered "Very Bad" (10 cm, severe disease activity).
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Change in Adult Stage 2 Disease Activity as Measured by the Patient Global Assessment
The Patient Global Assessment of the participant's current disease activity is assessed on a 10 cm linear horizontal visual analog scale, where the left hand extreme of the line is considered "Very Good" (0 cm, no disease activity) and the right hand extreme is considered "Very Bad" (10 cm, severe disease activity).
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C)
The Patient Global Impression of Change (PGI-C) is the participant's global impression of their clinical condition in terms of change relative to the start of treatment. Change is rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
Time frame: Weeks 4 Status Post Receipt of COVID-19 Vaccine Dose
Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C)
The Patient Global Impression of Change (PGI-C) is the participant's global impression of their clinical condition in terms of change relative to the start of treatment. Change is rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
Time frame: Weeks 4 Status Post Receipt of COVID-19 Vaccine Dose
Percent of Stage 1 Adult Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine
All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation. All AEs were classified by system organ class (SOC) and preferred term, according to a standardized thesaurus (Medical Dictionary for Regulatory Activities \[MedDRA\] version 24.0. Related AEs were defined as "possibly related" (the AE has a reasonable possibility to be related; there is evidence to suggest a causal relationship) or "related" (the adverse event is clearly related). Severity was assessed according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
Time frame: Up to Week 48 post study vaccination
Percent of Stage 2 Adult Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine
All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation. All AEs were classified by system organ class (SOC) and preferred term, according to a standardized thesaurus (Medical Dictionary for Regulatory Activities \[MedDRA\] version 24.0. Related AEs were defined as "possibly related" (the AE has a reasonable possibility to be related; there is evidence to suggest a causal relationship) or "related" (the adverse event is clearly related). Severity was assessed according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
Time frame: Up to Week 48 post study vaccination
Percent of Stage 1 Adult Participants Who Experience Any Serious Adverse Events (SAEs)
An event is considered "serious" if, in the view of either the investigator or Sponsor, it results in any of the following: 1. Death. 2. Life-threatening event: considered "life-threatening" if, in the view of either the investigator or Sponsor, its occurrence places the participant at immediate risk of death. It does not include an AE that, had it occurred in a more severe form, might have caused death. 3. Inpatient hospitalization or prolongation of existing hospitalization. 4. Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. 5. Congenital anomaly or birth defect. 6. Important medical events that may not result in death, be life threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above.
Time frame: Up to Week 48 post study vaccination
Percent of Stage 2 Adult Participants Who Experience Any Serious Adverse Events (SAEs)
An event is considered "serious" if, in the view of either the investigator or Sponsor, it results in any of the following: 1. Death. 2. Life-threatening event: considered "life-threatening" if, in the view of either the investigator or Sponsor, its occurrence places the participant at immediate risk of death. It does not include an AE that, had it occurred in a more severe form, might have caused death. 3. Inpatient hospitalization or prolongation of existing hospitalization. 4. Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. 5. Congenital anomaly or birth defect. 6. Important medical events that may not result in death, be life threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above.
Time frame: Up to Week 48 post study vaccination
Percent of Stage 1 Adult Participants Who Experience Any Medically Attended Adverse Events (MAAEs)
Medically attended adverse event (MAAE) is defined as a hospitalization, emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason that is considered possibly related or related to study vaccine.
Time frame: Up to Week 48 post study vaccination
Percent of Stage 2 Adult Participants Who Experience Any Medically Attended Adverse Events (MAAEs)
Medically attended adverse event (MAAE) is defined as a hospitalization, emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason that is considered possibly related or related to study vaccine.
Time frame: Up to Week 48 post study vaccination
Percent of Stage 1 Adult Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs)
A new onset chronic medical condition (NOCMC) is defined as any new ICD diagnosis (per current International Statistical Classification of Diseases and Related Health Problems) that is applied to the study participant during the course of the study, after receipt of the vaccine, that is expected to continue for at least 3 months and requires continued health care intervention.
Time frame: Up to Week 48 post study vaccination
Percent of Stage 2 Adult Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs)
A new onset chronic medical condition (NOCMC) is defined as any new ICD diagnosis (per current International Statistical Classification of Diseases and Related Health Problems) that is applied to the study participant during the course of the study, after receipt of the vaccine, that is expected to continue for at least 3 months and requires continued health care intervention.
Time frame: Up to Week 48 post study vaccination
Percent of Stage 1 Adult Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection
Efficacy measure.
Time frame: Up to Week 48 post study vaccination
Percent of Stage 2 Adult Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection
COVID-19 infections (all grades) were confirmed by molecular COVID-19 testing. AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 24.0.
Time frame: Up to Week 48 post study vaccination
Percentage of Stage 2 Pediatric Participants Who Seroconverted
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center Meso Scale Discovery 3 plex assay. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing antibody data were considered missing-completely-at-random. Seroconversion was assessed in the subgroup of participants who were anti-COVID-19 antibody negative at Week 0; defined as a result less than or equal to the positive threshold value (spike=10.8424, RBD=14.0858), defined independently for spike and RBD. Seroconversion was defined as having a result greater than the positive threshold at the Week 4 visit.
Time frame: Week 4 Status Post Receipt of COVID-19 Vaccination
Fold Increase in Stage 2 Pediatric Anti-COVID-19 Antibody Levels
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center Meso Scale Discovery 3 plex assay. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing antibody data were considered missing-completely-at-random. Fold increase was assessed in the subgroup of participants who were anti-COVID-19 antibody positive at Week 0; defined as having a result greater than the positive threshold value (spike=10.8424, RBD=14.0858), defined independently for spike and RBD. Fold increase = (antibody response at Week 4)/(antibody response at Week 0).
Time frame: Week 4 Status Post Receipt of COVID-19 Vaccination
Change in Stage 2 Pediatric Anti-COVID-19 Antibody Response
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) 3 plex assay (Wu-1 full-length spike, receptor binding domain (RBD), and N proteins). Wu-1 full-length spike and RBD were used to assess vaccine response. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing anti-COVID-19 antibody response data were considered to be missing-completely-at-random.
Time frame: Week 0 and Weeks 4 and 12 Status Post Receipt of COVID-19 Vaccination
Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Pediatric Samples
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) V-Plex ACE2 neutralization assay which measure antibodies that block the binding of angiotensin-converting enzyme 2 (ACE2) to the SARS-CoV-2 Spike antigens, including variants of the SARS-CoV-2 virus according to the manufacturer's instruction (MSD Catalog # K15654U). Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing anti-COVID-19 antibody response data were considered to be missing-completely-at-random. Results are reported as fold inhibition by a sample relative to signal from a 'diluent only' control (maximum ACE2 binding to antigen). Highly neutralizing samples show high fold inhibition whereas negative or low samples show low fold inhibition of ACE2 binding.
Time frame: Week 0 and Weeks 4 and 12 Status Post Receipt of COVID-19 Vaccination
Change in Stage 2 Pediatric Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C)
The Clinical Global Impression of Change (CGI-C) is the clinician's global impression of a participant's clinical condition in terms of change relative to the start of treatment. Change is rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
Time frame: Weeks 4 Status Post Receipt of COVID-19 Vaccine Dose
Change in Pediatric Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment
The Physician's Global Assessment of the participant's current disease activity is assessed on a 10 cm linear horizontal visual analog scale, where the left hand extreme of the line is considered "Very Good" (0 cm, no disease activity) and the right hand extreme is considered "Very Bad" (10 cm, severe disease activity).
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Change in Disease Activity in Stage 2 Pediatric Participants With Systemic Lupus Erythematosus (SLE) as Measured by Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K
The Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K is a validated, physician-based assessment tool used to measure the extent of lupus disease activity within the past 28 days. SLEDAI-2K total score is a weighted sum of the presence of 24 lupus disease symptoms and ranges from 0 to 105, with higher scores indicating more lupus disease activity present.
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Change in Pediatric Stage 2 Disease Activity as Measured by the Patient Global Assessment
The Patient Global Assessment of the participant's current disease activity is assessed on a 10 cm linear horizontal visual analog scale, where the left hand extreme of the line is considered "Very Good" (0 cm, no disease activity) and the right hand extreme is considered "Very Bad" (10 cm, severe disease activity).
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Change in Stage 2 Pediatric Disease Activity as Measured by the Patient Global Impression of Change (PGI-C)
The Patient Global Impression of Change (PGI-C) is the participant's global impression of their clinical condition in terms of change relative to the start of treatment. Change is rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
Time frame: Weeks 4 Status Post Receipt of COVID-19 Vaccine Dose
Percent of Stage 2 Pediatric Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine
All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation. All AEs were classified by system organ class (SOC) and preferred term, according to a standardized thesaurus (Medical Dictionary for Regulatory Activities \[MedDRA\] version 24.0. Related AEs were defined as "possibly related" (the AE has a reasonable possibility to be related; there is evidence to suggest a causal relationship) or "related" (the adverse event is clearly related). Severity was assessed according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
Time frame: Up to Week 48 post study vaccination
Percent of Stage 2 Pediatric Participants Who Experience Any Serious Adverse Events (SAEs)
An event is considered "serious" if, in the view of either the investigator or Sponsor, it results in any of the following: 1. Death. 2. Life-threatening event: considered "life-threatening" if, in the view of either the investigator or Sponsor, its occurrence places the participant at immediate risk of death. It does not include an AE that, had it occurred in a more severe form, might have caused death. 3. Inpatient hospitalization or prolongation of existing hospitalization. 4. Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. 5. Congenital anomaly or birth defect. 6. Important medical events that may not result in death, be life threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above.
Time frame: Up to Week 48 post study vaccination
Percent of Stage 2 Pediatric Participants Who Experience Any Medically Attended Adverse Events (MAAEs)
Medically attended adverse event (MAAE) is defined as a hospitalization, emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason that is considered possibly related or related to study vaccine.
Time frame: Up to Week 48 post study vaccination
Percent of Stage 2 Pediatric Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs)
A new onset chronic medical condition (NOCMC) is defined as any new ICD diagnosis (per current International Statistical Classification of Diseases and Related Health Problems) that is applied to the study participant during the course of the study, after receipt of the vaccine, that is expected to continue for at least 3 months and requires continued health care intervention.
Time frame: Up to Week 48 post study vaccination
Percent of Stage 2 Pediatric Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection
COVID-19 infections (all grades) were confirmed by molecular COVID-19 testing. AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 24.0.
Time frame: Up to Week 48 post study vaccination
19 adult sites and 12 pediatric sites were activated in the United States. 374 adult participants and 9 pediatric participants were screened from August 2021 until April 2023 in Stage 1 and 2 of the trial. Adult arms A3, B3, B6, D1, D3, E1, and E3; Pediatric Stage 1; Pediatric Stage 2 arms D1P, E1P, F1P, and F2P did not randomized/allocate or vaccinate participants. One participant was allocated to Adult arm F1 but was not vaccinated.
| Milestone | Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA) | Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA) | Cohort E, Arm E2: Alternative mRNA + Withhold IS (MTX) | Cohort E, Arm E4: Sanofi-GSK + Withhold IS (MTX) | Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT) | Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (BCDT) | Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT) | Cohort F, Arm F1: Janssen + Withhold IS (BCDT) | Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA) | Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 2 | 2 | 9 | 10 | 2 | 3 | 3 | 11 | 11 | 41 | 45 | 9 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 1 | 1 | 5 | 6 | 1 | 2 | 2 | 5 | 9 | 22 | 13 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 1 | 1 | 4 | 4 | 1 | 1 | 1 | 6 | 2 | 19 | 32 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 2 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Physician decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Did not receive vaccine at week 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Received a sars-cov-2 vaccine off study | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Other | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Rolled over to stage 2 of the study | 1 | 0 | 3 | 3 | 0 | 1 | 0 | 2 | 0 | 13 | 18 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA) | Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA) | Cohort E, Arm E2: Alternative mRNA + Withhold IS (MTX) | Cohort E, Arm E4: Sanofi-GSK + Withhold IS (MTX) | Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT) | Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (BCDT) | Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT) | Cohort F, Arm F1: Janssen + Withhold IS (BCDT) | Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA) | Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 9 | 0 | 8 | 0 | 57 | 2 | 0 | 1 | 1 | 1 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 8 | 0 | 5 | 0 | 33 | 2 | 0 | 0 | 1 | 1 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 3 | 0 | 24 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Physician decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 9 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Did not receive vaccine at week 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Received a sars-cov-2 vaccine off study | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 6 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Other reason | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA) | Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA) | Cohort E, Arm E2: Alternative mRNA + Withhold IS (MTX) | Cohort E, Arm E4: Sanofi-GSK + Withhold IS (MTX) | Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT) | Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (BCDT) | Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT) | Cohort F, Arm F1: Janssen + Withhold IS (BCDT) | Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA) | Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 0 | 6 | 0 | 0 | 20 | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 3 | 0 | 0 | 17 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 3 | 0 | 0 | 3 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Received a sars-cov-2 vaccine off study | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 2 | 0 | 0 | 2 | 0 | 0 | 0 |
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) 3 plex assay (Wu-1 full-length spike, receptor binding domain (RBD), and N proteins). A threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
| Percentage of participants | Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Cohort C, Arm C3: Janssen + Continue IS (BCDT) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 4, Wu-1 Full-Length Spike | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Week 4, Receptor Binding Domain (RBD) | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) 3 plex assay (Wu-1 full-length spike, receptor binding domain (RBD), and N proteins). A threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
| Percentage of participants | Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA) | Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA) | Cohort E, Arm E2: Alternative mRNA + Withhold IS (MTX) | Cohort E, Arm E4: Sanofi-GSK + Withhold IS (MTX) | Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT) | Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (BCDT) | Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT) |
|---|---|---|---|---|---|---|---|
| Week 4, Wu-1 Full-Length Spike | NA | NA | NA | NA | NA | NA | NA |
| Week 4, Receptor Binding Domain (RBD) | NA | NA | NA | NA | NA | NA | NA |
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) 3 plex assay (Wu-1 full-length spike, receptor binding domain (RBD), and N proteins). A threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
| Percentage of participants | Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA) | Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX) |
|---|---|---|
| Week 4, Wu-1 Full-Length Spike | NA | NA |
| Week 4, Receptor Binding Domain (RBD) | NA | NA |
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center Meso Scale Discovery 3 plex assay. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or COVID-19 vaccine given off-study were excluded from the analyses. Participants missing antibody data were considered missing-completely-at-random. Seroconversion was assessed in the subgroup of participants who were anti-COVID-19 antibody negative at Week 0; defined as a result less than or equal to the positive threshold value (spike=10.8424, RBD=14.0858). Anti-COVID-19 antibody negative at Week 0 is defined separately for spike and RBD. Seroconversion was defined as having a result greater than the positive threshold at the Week 4 visit.
| Participants | Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Cohort C, Arm C3: Janssen + Continue IS (BCDT) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Seroconverted, Wu-1 Full-Length Spike | 2 | — | 2 | 3 | 1 | 1 | 2 | 3 | 3 | 13 | 10 | 2 |
| Seroconverted, Receptor Binding Domain (RBD) | 2 | — | 2 | 3 | 1 | 1 | 3 | 2 | 2 | 12 | 12 | 1 |
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center Meso Scale Discovery 3 plex assay. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or COVID-19 vaccine given off-study were excluded from the analyses. Participants missing antibody data were considered missing-completely-at-random. Seroconversion was assessed in the subgroup of participants who were anti-COVID-19 antibody negative at Week 0; defined as a result less than or equal to the positive threshold value (spike=10.8424, RBD=14.0858). Anti-COVID-19 antibody negative at Week 0 is defined separately for spike and RBD. Seroconversion was defined as having a result greater than the positive threshold at the Week 4 visit.
| Participants | Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA) | Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA) | Cohort E, Arm E2: Alternative mRNA + Withhold IS (MTX) | Cohort E, Arm E4: Sanofi-GSK + Withhold IS (MTX) | Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT) | Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (BCDT) | Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT) |
|---|---|---|---|---|---|---|---|
| Seroconverted, Wu-1 Full-Length Spike | 1 | 0 | — | — | 7 | 0 | 0 |
| Seroconverted, Receptor Binding Domain (RBD) | 1 | 1 | 1 | — | 4 | 0 | 0 |
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center Meso Scale Discovery 3 plex assay. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing antibody data were considered missing-completely-at-random. Fold increase was assessed in the subgroup of participants who were anti-COVID-19 antibody positive at Week 0; defined as having a result greater than the positive threshold value (spike=10.8424, RBD=14.0858). Anti-COVID-19 antibody positive at Week 0 is defined separately for spike and RBD. Fold increase = (antibody response at Week 4)/(antibody response at Week 0).
| Fold Change | Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Cohort C, Arm C3: Janssen + Continue IS (BCDT) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Fold Change, Wu-1 Full-Length Spike | — | 12.31 ± NA | 35.78 ± 326.98 | 65.38 ± 165.08 | 3.97 ± NA | 66.34 ± 30.51 | 111.83 ± NA | 99.52 ± 168.72 | 95.54 ± 75.93 | 2.58 ± 257.03 | 4.09 ± 1485.84 | 2.91 ± NA |
| Fold Change, Receptor Binding Domain (RBD) | — | 16.7 ± NA | 85.53 ± 101.49 | 35.32 ± 358.06 | 9.3 ± NA | 85.18 ± 53.39 | — | 67.9 ± 142.36 | 80.66 ± 115.89 | 4.99 ± 1175.81 | 1.95 ± 86.7 | 4.48 ± NA |
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center Meso Scale Discovery 3 plex assay. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing antibody data were considered missing-completely-at-random. Fold increase was assessed in the subgroup of participants who were anti-COVID-19 antibody positive at Week 0; defined as having a result greater than the positive threshold value (spike=10.8424, RBD=14.0858). Anti-COVID-19 antibody positive at Week 0 is defined separately for spike and RBD. Fold increase = (antibody response at Week 4)/(antibody response at Week 0).
| Fold Change | Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA) | Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA) | Cohort E, Arm E2: Alternative mRNA + Withhold IS (MTX) | Cohort E, Arm E4: Sanofi-GSK + Withhold IS (MTX) | Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT) | Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (BCDT) | Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT) |
|---|---|---|---|---|---|---|---|
| Fold Change, Wu-1 Full-Length Spike | 54.15 ± 103.71 | 9.97 ± 146.18 | 49.62 ± 603.67 | 5.17 ± 278.52 | 2.74 ± 287.75 | — | 0.82 ± 12.82 |
| Fold Change, Receptor Binding Domain (RBD) | 93.53 ± 111.68 | 17.65 ± 309.52 | 44.49 ± 716.62 | 5.46 ± 299.38 | 4.02 ± 648.61 | — | 0.8 ± 10.47 |
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) 3 plex assay (Wu-1 full-length spike, receptor binding domain (RBD), and N proteins). Wu-1 full-length spike and RBD were used to assess vaccine response. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing anti-COVID-19 antibody response data were considered to be missing-completely-at-random.
| IU/mL | Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Cohort C, Arm C3: Janssen + Continue IS (BCDT) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 0, Wu-1 Full-Length Spike | 2.52 ± 221.96 | 224.49 ± NA | 14.52 ± 196.41 | 8.67 ± 1803.07 | 16.83 ± 279.39 | 18.83 ± 87.58 | 5.31 ± 107.14 | 7.22 ± 121.07 | 11.72 ± 117.09 | 0.95 ± 289.7 | 1.99 ± 1091.74 | 2.25 ± 1536.33 |
| Week 4, Wu-1 Full-Length Spike | 321.14 ± 10668.22 | 2763.2 ± NA | 518.82 ± 452.03 | 632.72 ± 2925.17 | 296.41 ± 70.11 | 1681.23 ± 20.2 | 1104.81 ± 436.85 | 459.48 ± 1333.45 | 2211.08 ± 252.38 | 4.88 ± 5181.02 | 8.02 ± 8352.66 | 9.03 ± 62605.68 |
| Week 12, Wu-1 Full-Length Spike | 356.28 ± 6108.73 | 3121.73 ± NA | 331.49 ± 333.85 | 626.32 ± 650.04 | 232.72 ± 97.53 | 660.98 ± 91.92 | 296.69 ± 481.82 | 362.53 ± 214.09 | 597.3 ± 216.04 | 6.88 ± 3896.56 | 6.28 ± 6838.48 | 5.59 ± 1429421.94 |
| Week 0, Receptor Binding Domain (RBD) | 6.45 ± 39.72 | 207.45 ± NA | 12.34 ± 142.28 | 12.36 ± 424.64 | 12.27 ± 67.11 | 24.54 ± 92.01 | 6.65 ± 45.13 | 13.88 ± 65.76 | 17.42 ± 119.26 | 2.45 ± 134.77 | 1.74 ± 206.49 | 7.53 ± 282.2 |
| Week 4, Receptor Binding Domain (RBD) | 434.06 ± 157747.37 | 3464.82 ± NA | 458.18 ± 1185.39 | 491.61 ± 7488.68 | 355.86 ± 131.08 | 2266.65 ± 59.16 | 1751.42 ± 544.5 | 601.12 ± 797.51 | 3074.6 ± 246.3 | 8.84 ± 943.12 | 7.73 ± 3104.64 | 16.64 ± 4363.12 |
| Week 12, Receptor Binding Domain (RBD) | 466.11 ± 104511.25 | 3734.51 ± NA | 272.17 ± 920.54 | 617.58 ± 630.84 | 276.55 ± 225.66 | 926.48 ± 162 | 497.09 ± 542.78 | 456.9 ± 123.89 | 948.78 ± 219.75 | 10.36 ± 989.47 | 6.61 ± 2278.71 | 12.37 ± 102810.04 |
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) 3 plex assay (Wu-1 full-length spike, receptor binding domain (RBD), and N proteins). Wu-1 full-length spike and RBD were used to assess vaccine response. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing anti-COVID-19 antibody response data were considered to be missing-completely-at-random.
| IU/mL | Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA) | Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA) | Cohort E, Arm E2: Alternative mRNA + Withhold IS (MTX) | Cohort E, Arm E4: Sanofi-GSK + Withhold IS (MTX) | Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT) | Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (BCDT) | Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT) |
|---|---|---|---|---|---|---|---|
| Week 0, Wu-1 Full-Length Spike | 22.14 ± 1247.32 | 48.64 ± 23319.38 | 127.11 ± 3076.50 | 228.43 ± 163.73 | 3.83 ± 1803.22 | 0.33 ± 144.78 | 139.71 ± 8202.42 |
| Week 4, Wu-1 Full-Length Spike | 1329.5 ± 3501.10 | 306.1 ± 1263457.31 | 6307.1 ± 166.16 | 1122.85 ± 156.9 | 9.67 ± 7718.35 | 0.33 ± 145.66 | 137.36 ± 5885.99 |
| Week 12, Wu-1 Full-Length Spike | 684.1 ± 7400.94 | 205.05 ± 683623.84 | 1143.73 ± 109.59 | 701.21 ± 193.34 | 13.88 ± 6077.43 | 0.15 ± NA | 88.11 ± 4049.13 |
| Week 0, Receptor Binding Domain (RBD) | 18.28 ± 314.85 | 40.85 ± 5113.92 | 136.55 ± 5462.96 | 312.05 ± 167.64 | 3.87 ± 933.74 | 1.17 ± 58.88 | 195.64 ± 32100.88 |
| Week 4, Receptor Binding Domain (RBD) | 1583.14 ± 2496.89 | 593.17 ± 173461.30 | 8464.11 ± 216.65 | 1668.91 ± 162.22 | 7.56 ± 4854.01 | 1.24 ± 69.04 | 187.34 ± 21600.14 |
| Week 12, Receptor Binding Domain (RBD) | 812.4 ± 6728.02 | 311.56 ± 120989.28 | 1458.9 ± 113.83 | 1030.47 ± 203.85 | 11.4 ± 3794.97 | 0.8 ± NA | 123.87 ± 9374.45 |
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) V-Plex ACE2 neutralization assay which measure antibodies that block the binding of angiotensin-converting enzyme 2 (ACE2) to the SARS-CoV-2 Spike antigens, including variants of the SARS-CoV-2 virus according to the manufacturer's instruction (MSD Catalog # K15654U). Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing anti-COVID-19 antibody response data were considered to be missing-completely-at-random. Results are reported as fold inhibition by a sample relative to signal from a 'diluent only' control (maximum ACE2 binding to antigen). Highly neutralizing samples show high fold inhibition whereas negative or low samples show low fold inhibition of ACE2 binding.
| Fold Inhibition | Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Cohort C, Arm C3: Janssen + Continue IS (BCDT) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 0 | 1 ± 0 | 2 ± NA | 1 ± 0 | 1.08 ± 23.42 | 1 ± 0.00 | 1 ± 0 | 1 ± 0 | 1 ± 0 | 1 ± 0 | 1 ± 0 | 1.02 ± 10.36 | 1.09 ± 24.88 |
| Week 4 | 15.03 ± 154928.64 | 18 ± NA | 5.96 ± 291.28 | 9.49 ± 577.34 | 3.46 ± 91.02 | 5.52 ± 255.65 | 40.15 ± 914418.24 | 6.16 ± 383.45 | 24.88 ± 2444.17 | 1.16 ± 38.70 | 1.14 ± 31.58 | 1.31 ± 73.48 |
| Week 12 | 9.11 ± 13182.95 | 30 ± NA | 2.99 ± 249.41 | 3.56 ± 135.35 | 4.47 ± 162.84 | 1.59 ± 41.68 | 5.67 ± 9124.55 | 2.16 ± 63.89 | 4.25 ± 203.12 | 1.08 ± 22.87 | 1.55 ± 653.94 | 1.59 ± 94.74 |
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) V-Plex ACE2 neutralization assay which measure antibodies that block the binding of angiotensin-converting enzyme 2 (ACE2) to the SARS-CoV-2 Spike antigens, including variants of the SARS-CoV-2 virus according to the manufacturer's instruction (MSD Catalog # K15654U). Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing anti-COVID-19 antibody response data were considered to be missing-completely-at-random. Results are reported as fold inhibition by a sample relative to signal from a 'diluent only' control (maximum ACE2 binding to antigen). Highly neutralizing samples show high fold inhibition whereas negative or low samples show low fold inhibition of ACE2 binding.
| Fold Inhibition | Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA) | Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA) | Cohort E, Arm E2: Alternative mRNA + Withhold IS (MTX) | Cohort E, Arm E4: Sanofi-GSK + Withhold IS (MTX) | Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT) | Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (BCDT) | Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT) |
|---|---|---|---|---|---|---|---|
| Week 0 | 1 ± 0.00 | 1.64 ± 51.25 | 3.2 ± 9598.10 | 1.62 ± 59.19 | 1.14 ± 86.32 | 1 ± 0 | 9.42 ± 412.99 |
| Week 4 | 23.32 ± 651.97 | 15.31 ± 6552.75 | 109.39 ± 1119.69 | 7.34 ± 1124.11 | 1.54 ± 195.75 | 1 ± 0 | 6.6 ± 268.60 |
| Week 12 | 7.61 ± 701.06 | 10.34 ± 4255.15 | 5.71 ± 319.78 | 4.03 ± 451.42 | 1.43 ± 117.21 | 1 ± NA | 2.9 ± 100.15 |
The Clinical Global Impression of Change (CGI-C) is the clinician's global impression of a participant's clinical condition in terms of change relative to the start of treatment. Change is rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
| Participants | Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Cohort C, Arm C3: Janssen + Continue IS (BCDT) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Very much improved | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Much improved | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Minimally improved | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 2 | 4 | 0 | 0 |
| No change | 1 | 0 | 7 | 6 | 0 | 3 | 2 | 7 | 7 | 26 | 42 | 8 |
| Minimally worse | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 2 | 1 | 6 | 2 | 0 |
| Much worse | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Very much worse | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
The Clinical Global Impression of Change (CGI-C) is the clinician's global impression of a participant's clinical condition in terms of change relative to the start of treatment. Change is rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
| Participants | Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA) | Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA) | Cohort E, Arm E2: Alternative mRNA + Withhold IS (MTX) | Cohort E, Arm E4: Sanofi-GSK + Withhold IS (MTX) | Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT) | Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (BCDT) | Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT) |
|---|---|---|---|---|---|---|---|
| Very much improved | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Much improved | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Minimally improved | 2 | 1 | 0 | 0 | 3 | 0 | 0 |
| No change | 7 | 3 | 8 | 4 | 44 | 2 | 18 |
| Minimally worse | 0 | 1 | 0 | 1 | 5 | 0 | 2 |
| Much worse | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Very much worse | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
The Physician's Global Assessment of the participant's current disease activity is assessed on a 10 cm linear horizontal visual analog scale, where the left hand extreme of the line is considered "Very Good" (0 cm, no disease activity) and the right hand extreme is considered "Very Bad" (10 cm, severe disease activity).
| cm | Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Cohort C, Arm C3: Janssen + Continue IS (BCDT) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 0 | 1.1 ± 1.3 | 0 ± NA | 1.2 ± 0.9 | 2.5 ± 2.6 | 1.9 ± 1.5 | 1.2 ± 0.6 | 1.2 ± 1.6 | 1.5 ± 1.2 | 1.2 ± 1.8 | 1.1 ± 1.5 | 1.6 ± 2.6 | 1.3 ± 1.8 |
| Week 4 | 2.8 ± 1.6 | 0.4 ± NA | 1.6 ± 1.2 | 1.7 ± 1.9 | 4.5 ± 2.8 | 0.7 ± 0.8 | 0.5 ± 0.8 | 1.2 ± 1.2 | 1.3 ± 1.6 | 1.3 ± 1.7 | 0.5 ± 1 | 0.7 ± 1.1 |
| Week 12 | 2.1 ± 2.7 | 0.2 ± NA | 1.6 ± 1.1 | 1.2 ± 1.3 | 3.4 ± 4.4 | 1 ± 0.7 | 1.8 ± 0.8 | 0.7 ± 0.9 | 1.3 ± 1.1 | 1.6 ± 1.9 | 0.8 ± 1.5 | 1.1 ± 1.8 |
The Physician's Global Assessment of the participant's current disease activity is assessed on a 10 cm linear horizontal visual analog scale, where the left hand extreme of the line is considered "Very Good" (0 cm, no disease activity) and the right hand extreme is considered "Very Bad" (10 cm, severe disease activity).
| cm | Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA) | Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA) | Cohort E, Arm E2: Alternative mRNA + Withhold IS (MTX) | Cohort E, Arm E4: Sanofi-GSK + Withhold IS (MTX) | Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT) | Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (BCDT) | Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT) |
|---|---|---|---|---|---|---|---|
| Week 0 | 1.7 ± 1.6 | 2.6 ± 3.1 | 0.4 ± 0.4 | 1 ± 0.8 | 1.4 ± 2 | 0.8 ± 0.1 | 1.4 ± 1.1 |
| Week 4 | 1.7 ± 1.7 | 3.4 ± 2.4 | 0.6 ± 0.5 | 0.9 ± 0.6 | 1.54 ± 1.8 | 1.1 ± 0.9 | 1.3 ± 1.6 |
| Week 12 | 1.3 ± 1.2 | 1.8 ± 2.1 | 0.5 ± 0.4 | 1 ± 0.8 | 1.6 ± 1.8 | 0.2 ± 0.1 | 1 ± 1.4 |
The Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) is a validated, physician-based assessment tool used to measure the extent of lupus disease activity within the past 28 days. hSLEDAI total score is a weighted sum of the presence of 24 lupus disease symptoms and ranges from 0 to 105, with higher scores indicating more lupus disease activity present.
| hSLEDAI Score | Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Cohort C, Arm C3: Janssen + Continue IS (BCDT) |
|---|---|---|---|---|---|---|---|---|---|---|
| Week 0 | 0 ± NA | 0 ± NA | 2 ± 2.19 | 7.83 ± 6.21 | 4 ± NA | 2 ± 3.46 | 0.67 ± 1.15 | 2 ± 2.83 | 4 ± NA | 0 ± NA |
| Week 4 | 4 ± NA | 2 ± NA | 3.4 ± 2.97 | 5.57 ± 4.31 | 6 ± NA | 2.67 ± 3.06 | 0.67 ± 1.15 | 3 ± 4.24 | 4 ± 2.83 | 2 ± NA |
| Week 12 | 0 ± NA | 2 ± NA | 3.33 ± 3.27 | 5.57 ± 6.11 | 0 ± NA | 0 ± 0 | 1.33 ± 2.31 | 4 ± NA | 4 ± 2.83 | 0 ± NA |
The Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) is a validated, physician-based assessment tool used to measure the extent of lupus disease activity within the past 28 days. hSLEDAI total score is a weighted sum of the presence of 24 lupus disease symptoms and ranges from 0 to 105, with higher scores indicating more lupus disease activity present.
| hSLEDAI Score | Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA) | Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA) | Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT) |
|---|---|---|---|
| Week 0 | 4 ± 4 | 2 ± NA | 4 ± 4.4 |
| Week 4 | 0.7 ± 1.2 | 4 ± 2.8 | 4.3 ± 4 |
| Week 12 | 0.7 ± 1.2 | 2 ± 0 | 3 ± 1.4 |
The Thanou Modified Safety of Estrogens in Lupus Erythematosus: National Assessment- Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) assesses systemic lupus erythematosus (SLE) disease activity and categorizes mild/moderate or severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), other disease activity criteria, and hospitalization due to SLE. The hSLEDAI is a validated, physician-based assessment tool used to measure the extent of lupus disease activity within the past 28 days. hSLEDAI total score is a weighted sum of the presence of 24 lupus disease symptoms and ranges from 0 to 105, with higher scores indicating more lupus disease activity present.
| Participants | Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Cohort C, Arm C3: Janssen + Continue IS (BCDT) |
|---|---|---|---|---|---|---|---|---|---|---|
| Severe SELENA-SLEDAI Flare at Week 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Severe SELENA-SLEDAI Flare at Week 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Severe SELENA-SLEDAI Flare at Week 12 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
The Thanou Modified Safety of Estrogens in Lupus Erythematosus: National Assessment- Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) assesses systemic lupus erythematosus (SLE) disease activity and categorizes mild/moderate or severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), other disease activity criteria, and hospitalization due to SLE. The hSLEDAI is a validated, physician-based assessment tool used to measure the extent of lupus disease activity within the past 28 days. hSLEDAI total score is a weighted sum of the presence of 24 lupus disease symptoms and ranges from 0 to 105, with higher scores indicating more lupus disease activity present.
| Participants | Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA) | Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA) | Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT) |
|---|---|---|---|
| Severe SELENA-SLEDAI Flare at Week 0 | 0 | 0 | 0 |
| Severe SELENA-SLEDAI Flare at Week 4 | 0 | 0 | 0 |
| Severe SELENA-SLEDAI Flare at Week 12 | 0 | 0 | 0 |
The Disease Activity Score 28 C-reactive Protein (DAS28-CRP) is: a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (\>5.1=high disease activity; \<=3.2=low disease activity; \<2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm). Reference: van Gestel AM et al. Arthritis Rheum.1998; 41(10): 1845-50.
| DAS28-CRP Score | Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) |
|---|---|---|---|---|---|---|
| Week 0 | 2.7 ± 1.1 | 2.5 ± NA | 2.1 ± 0.8 | 2.7 ± 1.3 | 3.1 ± 1.4 | 3.3 ± 1.5 |
| Week 4 | 3 ± 0.7 | 2.6 ± 0.9 | 1.6 ± 0.6 | 2.8 ± 1.1 | 3.3 ± 1.3 | 3.3 ± 1.1 |
| Week 12 | 3.5 ± 0 | 3.5 ± NA | 2.1 ± 1.1 | 2.8 ± 1 | 3.4 ± 2.3 | 3.2 ± 1.7 |
The Disease Activity Score 28 C-reactive Protein (DAS28-CRP) is: a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (\>5.1=high disease activity; \<=3.2=low disease activity; \<2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm). Reference: van Gestel AM et al. Arthritis Rheum.1998; 41(10): 1845-50.
| DAS28-CRP Score | Cohort E, Arm E2: Alternative mRNA + Withhold IS (MTX) | Cohort E, Arm E4: Sanofi-GSK + Withhold IS (MTX) | Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT) | Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT) |
|---|---|---|---|---|
| Week 0 | 1.9 ± 0.6 | 1.8 ± 0.7 | 2.8 ± 1.2 | 3 ± 0.8 |
| Week 4 | 2.1 ± 0.5 | 2 ± 0.7 | 2.6 ± 1 | 2.6 ± 0.9 |
| Week 12 | 1.9 ± 0.4 | 2 ± 0.8 | 3 ± 1.2 | 2.3 ± 0.4 |
Severe disease flare included onset of new or significant worsening of internal organ involvement requiring hospitalization or change in treatment. Internal organ involvement included scleroderma renal crisis, interstitial lung disease, left or right sided heart failure, pulmonary arterial hypertension on right-sided heart catheterization or other worsening of internal organs.
| Participants | Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) |
|---|---|---|---|---|---|
| Severe Flare at Week 0 | 0 | 0 | 0 | 0 | 0 |
| Severe Flare at Week 4 | 0 | 0 | 0 | 0 | 0 |
| Severe Flare at Week 12 | 0 | 0 | 0 | 0 | 0 |
Severe disease flare included onset of new or significant worsening of internal organ involvement requiring hospitalization or change in treatment. Internal organ involvement included scleroderma renal crisis, interstitial lung disease, left or right sided heart failure, pulmonary arterial hypertension on right-sided heart catheterization or other worsening of internal organs.
| Participants | Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA) | Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA) | Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT) |
|---|---|---|---|
| Severe Flare at Week 0 | 0 | 0 | 0 |
| Severe Flare at Week 4 | 0 | 0 | 0 |
| Severe Flare at Week 12 | 0 | 0 | 0 |
The Pemphigus Disease Area Index (PDAI) was developed by the International Pemphigus Committee and measures both activity of and damage due to pemphigus on the skin, scalp, and mucous membranes. Total scores can range from 0 to a possible 263 maximum score, with 250 points representing disease activity (120 points for skin activity, 10 points for scalp activity, and 120 points for mucosal activity) and 13 points representing disease damage. Higher scores reflect worse disease.
| PDAI Total Activity Score | Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) |
|---|---|---|
| Week 0 | 1 ± NA | 0 ± 0 |
| Week 4 | 5 ± NA | 0 ± 0 |
| Week 12 | 0 ± NA | 1 ± 1.41 |
The Pemphigus Disease Area Index (PDAI) was developed by the International Pemphigus Committee and measures both activity of and damage due to pemphigus on the skin, scalp, and mucous membranes. Total scores can range from 0 to a possible 263 maximum score, with 250 points representing disease activity (120 points for skin activity, 10 points for scalp activity, and 120 points for mucosal activity) and 13 points representing disease damage. Higher scores reflect worse disease.
| PDAI Total Activity Score | Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT) | Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT) |
|---|---|---|
| Week 0 | 0 ± 0 | 0 ± 0 |
| Week 4 | 0 ± 0 | 0 ± 0 |
| Week 12 | 0 ± 0 | 0 ± 0 |
Relapse required: either criteria (a) with investigator determination of relapse or criteria (a) and (b): (a) New, recurrent or worsening neurological symptoms attributable to MS, that meet all of the following: i. Appeared or evolved subacutely (over \<3 months). ii. Persisting \>24 hours. iii. Can't be attributed to confounding factors. iv. Occur ≥30 days after onset of a prior confirmed relapse. (b) New, recurrent or worsening neurological symptoms accompanied by corresponding objective worsening on neurologic examination with an increase of any one of the following compared to the immediate prior assessment: i. ≥0.5 step(s) on the Expanded Disability Status Scale (EDSS), ii. ≥2 points on one Functional Systems Score (FSS), iii. ≥1 point on two or more FSS. Episodic spasms, sexual dysfunction, fatigue, mood change, or bladder/bowel urgency or incontinence will not suffice to establish relapse. Sexual dysfunction and fatigue will not contribute to the EDSS/FSS for assessing relapse.
| Participants | Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Cohort C, Arm C3: Janssen + Continue IS (BCDT) |
|---|---|---|---|
| MS Relapse at Screening | 0 | 0 | 0 |
| MS Relapse at Week 4 | 0 | 0 | 0 |
| MS Relapse at Week 12 | 0 | 0 | 0 |
Relapse required: either criteria (a) with investigator determination of relapse or criteria (a) and (b): (a) New, recurrent or worsening neurological symptoms attributable to MS, that meet all of the following: i. Appeared or evolved subacutely (over \<3 months). ii. Persisting \>24 hours. iii. Can't be attributed to confounding factors. iv. Occur ≥30 days after onset of a prior confirmed relapse. (b) New, recurrent or worsening neurological symptoms accompanied by corresponding objective worsening on neurologic examination with an increase of any one of the following compared to the immediate prior assessment: i. ≥0.5 step(s) on the Expanded Disability Status Scale (EDSS), ii. ≥2 points on one Functional Systems Score (FSS), iii. ≥1 point on two or more FSS. Episodic spasms, sexual dysfunction, fatigue, mood change, or bladder/bowel urgency or incontinence will not suffice to establish relapse. Sexual dysfunction and fatigue will not contribute to the EDSS/FSS for assessing relapse.
| Participants | Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT) | Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (BCDT) | Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT) |
|---|---|---|---|
| MS Relapse at Screening | 0 | 0 | 0 |
| MS Relapse at Week 4 | 0 | 0 | 0 |
| MS Relapse at Week 12 | 0 | 0 | 0 |
The Juvenile Arthritis Disease Activity Score 10-C-reactive Protein (JADAS10-CRP) is a score on a scale (0 to 40) indicating activity of juvenile idiopathic arthritis. Total active joints are scored 0 to 10, with an active joint count \>10 scored as 10 points. The Physician's Global Assessment and Patient's Global Assessment are measured on a 0-10 scale (0 cm, no disease activity to 10 cm, worst disease activity). CRP is normalized to a 0 to 10 scale according to the following formula: (CRP (mg/L) - 10)/10. CRP values \<10 mg/L are scored as 0, and CRP \>110 mg/L are scored as 10. The final score is given by the simple sum of its component. Higher scores indicate worse disease activity.
| JADAS10 Score | Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX) |
|---|---|
| Week 0 | 0.8 ± NA |
| Week 4 | 0.6 ± NA |
| Week 12 | 0.4 ± NA |
The Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Short Form (Version 2.0) will be used to assess trends over time in this state of health measure. The PROMIS-29 consists of 7 domains related to physical, mental and social health. Raw scores are calculated for each domain and translated into a T-score per the PROMIS-29 scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. Physical Function domain score is presented. A higher score represents better functioning for the Physical Function domain.
| T-Score | Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Cohort C, Arm C3: Janssen + Continue IS (BCDT) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 0 | 37.9 ± NA | 43.4 ± NA | 47.6 ± 10.1 | 40.2 ± 3.9 | 35.6 ± 3.3 | 50.1 ± 6.1 | 39.6 ± 5 | 48.9 ± 9 | 41.8 ± 12 | 43.5 ± 9.5 | 44.2 ± 9.9 | 43.5 ± 11.8 |
| Week 4 | 39.8 ± 0.9 | 41.8 ± NA | 48.9 ± 8.7 | 42.7 ± 10 | 41.9 ± 2.1 | 46.5 ± 2.7 | 42.7 ± 12.3 | 47.2 ± 10.5 | 41.7 ± 10.5 | 43.5 ± 9.1 | 44.7 ± 10.5 | 43.6 ± 11.7 |
| Week 12 | 37.3 ± 0.8 | 56.9 ± NA | 47.6 ± 10.1 | 42.1 ± 7.7 | 35 ± 2.4 | 45.3 ± 0 | 39.3 ± 7.5 | 46.1 ± 11.5 | 41.1 ± 11.9 | 43.5 ± 9.4 | 44.7 ± 9.5 | 44.1 ± 11.9 |
The Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Short Form (Version 2.0) will be used to assess trends over time in this state of health measure. The PROMIS-29 consists of 7 domains related to physical, mental and social health. Raw scores are calculated for each domain and translated into a T-score per the PROMIS-29 scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. Physical Function domain score is presented. A higher score represents better functioning for the Physical Function domain.
| T-Score | Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA) | Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA) | Cohort E, Arm E2: Alternative mRNA + Withhold IS (MTX) | Cohort E, Arm E4: Sanofi-GSK + Withhold IS (MTX) | Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT) | Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (BCDT) | Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT) |
|---|---|---|---|---|---|---|---|
| Week 0 | 44.9 ± 7.9 | 46.3 ± 7.6 | 48.3 ± 10.4 | 48.3 ± 8.4 | 45.9 ± 9.9 | 56.9 ± 0 | 47.1 ± 9.5 |
| Week 4 | 46.4 ± 8.5 | 42.5 ± 10.5 | 48.4 ± 10.4 | 47.2 ± 9.4 | 44.9 ± 9.6 | 56.9 ± 0 | 48.6 ± 9.6 |
| Week 12 | 45.5 ± 9.3 | 46.8 ± 9.3 | 47.6 ± 9 | 44.2 ± 8.5 | 43.9 ± 10 | 51.1 ± 8.2 | 48.3 ± 9.4 |
The Patient Global Assessment of the participant's current disease activity is assessed on a 10 cm linear horizontal visual analog scale, where the left hand extreme of the line is considered "Very Good" (0 cm, no disease activity) and the right hand extreme is considered "Very Bad" (10 cm, severe disease activity).
| cm | Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Cohort C, Arm C3: Janssen + Continue IS (BCDT) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 0 | 7.2 ± 2.1 | 3 ± NA | 3.1 ± 2.9 | 3.8 ± 2.9 | 5.8 ± 1.8 | 4.8 ± 1.9 | 5.4 ± 1.6 | 3.7 ± 2.4 | 5.1 ± 3.6 | 3.8 ± 2.4 | 3.2 ± 2.9 | 3.9 ± 3.2 |
| Week 4 | 7.9 ± 0.5 | 6.5 ± NA | 2.7 ± 2.3 | 3.1 ± 2.3 | 4.9 ± 4.4 | 6.5 ± 0.9 | 5.6 ± 1.8 | 3.6 ± 2.9 | 4.9 ± 3.6 | 3.3 ± 2.6 | 2.6 ± 2.4 | 3 ± 2.6 |
| Week 12 | 5.8 ± 1.1 | 7.5 ± NA | 3.5 ± 2.9 | 3.7 ± 3.2 | 6.2 ± 1.1 | 4.6 ± 1.1 | 6.8 ± 1.5 | 4.3 ± 3.1 | 4.9 ± 3 | 3.5 ± 2.5 | 2.3 ± 2.2 | 2.3 ± 2.3 |
The Patient Global Assessment of the participant's current disease activity is assessed on a 10 cm linear horizontal visual analog scale, where the left hand extreme of the line is considered "Very Good" (0 cm, no disease activity) and the right hand extreme is considered "Very Bad" (10 cm, severe disease activity).
| cm | Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA) | Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA) | Cohort E, Arm E2: Alternative mRNA + Withhold IS (MTX) | Cohort E, Arm E4: Sanofi-GSK + Withhold IS (MTX) | Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT) | Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (BCDT) | Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT) |
|---|---|---|---|---|---|---|---|
| Week 0 | 3.2 ± 2.6 | 2.7 ± 3.4 | 3.2 ± 2.1 | 2.8 ± 2.6 | 2.7 ± 2.5 | 2.6 ± 3.4 | 2.6 ± 2.6 |
| Week 4 | 3 ± 2.1 | 2.9 ± 3.1 | 3 ± 2.5 | 3 ± 2 | 3 ± 2.5 | 1 ± 1.4 | 2.7 ± 2.9 |
| Week 12 | 2.9 ± 2.7 | 1.8 ± 2.2 | 3.1 ± 2.3 | 3.9 ± 2.7 | 3.1 ± 2.5 | 2.5 ± 3.5 | 1.9 ± 2.2 |
The Patient Global Impression of Change (PGI-C) is the participant's global impression of their clinical condition in terms of change relative to the start of treatment. Change is rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
| Participants | Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Cohort C, Arm C3: Janssen + Continue IS (BCDT) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Very much improved | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Much improved | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Minimally improved | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| No change | 1 | 1 | 8 | 7 | 1 | 2 | 2 | 8 | 6 | 31 | 41 | 7 |
| Minimally worse | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 2 | 5 | 1 | 0 |
| Much worse | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 2 | 0 |
| Very much worse | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
The Patient Global Impression of Change (PGI-C) is the participant's global impression of their clinical condition in terms of change relative to the start of treatment. Change is rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
| Participants | Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA) | Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA) | Cohort E, Arm E2: Alternative mRNA + Withhold IS (MTX) | Cohort E, Arm E4: Sanofi-GSK + Withhold IS (MTX) | Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT) | Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (BCDT) | Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT) |
|---|---|---|---|---|---|---|---|
| Very much improved | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Much improved | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Minimally improved | 2 | 2 | 1 | 0 | 3 | 0 | 0 |
| No change | 7 | 2 | 7 | 5 | 46 | 2 | 19 |
| Minimally worse | 0 | 0 | 0 | 0 | 2 | 0 | 1 |
| Much worse | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Very much worse | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation. All AEs were classified by system organ class (SOC) and preferred term, according to a standardized thesaurus (Medical Dictionary for Regulatory Activities \[MedDRA\] version 24.0. Related AEs were defined as "possibly related" (the AE has a reasonable possibility to be related; there is evidence to suggest a causal relationship) or "related" (the adverse event is clearly related). Severity was assessed according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
| Participants | Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Cohort C, Arm C3: Janssen + Continue IS (BCDT) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Percent of Stage 1 Adult Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 1 | 0 |
All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation. All AEs were classified by system organ class (SOC) and preferred term, according to a standardized thesaurus (Medical Dictionary for Regulatory Activities \[MedDRA\] version 24.0. Related AEs were defined as "possibly related" (the AE has a reasonable possibility to be related; there is evidence to suggest a causal relationship) or "related" (the adverse event is clearly related). Severity was assessed according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
| Participants | Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA) | Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA) | Cohort E, Arm E2: Alternative mRNA + Withhold IS (MTX) | Cohort E, Arm E4: Sanofi-GSK + Withhold IS (MTX) | Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT) | Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (BCDT) | Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT) |
|---|---|---|---|---|---|---|---|
| Percent of Stage 2 Adult Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine | 2 | 0 | 1 | 1 | 4 | 0 | 0 |
An event is considered "serious" if, in the view of either the investigator or Sponsor, it results in any of the following: 1. Death. 2. Life-threatening event: considered "life-threatening" if, in the view of either the investigator or Sponsor, its occurrence places the participant at immediate risk of death. It does not include an AE that, had it occurred in a more severe form, might have caused death. 3. Inpatient hospitalization or prolongation of existing hospitalization. 4. Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. 5. Congenital anomaly or birth defect. 6. Important medical events that may not result in death, be life threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above.
| Participants | Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Cohort C, Arm C3: Janssen + Continue IS (BCDT) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Percent of Stage 1 Adult Participants Who Experience Any Serious Adverse Events (SAEs) | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 5 | 4 | 0 |
An event is considered "serious" if, in the view of either the investigator or Sponsor, it results in any of the following: 1. Death. 2. Life-threatening event: considered "life-threatening" if, in the view of either the investigator or Sponsor, its occurrence places the participant at immediate risk of death. It does not include an AE that, had it occurred in a more severe form, might have caused death. 3. Inpatient hospitalization or prolongation of existing hospitalization. 4. Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. 5. Congenital anomaly or birth defect. 6. Important medical events that may not result in death, be life threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above.
| Participants | Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA) | Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA) | Cohort E, Arm E2: Alternative mRNA + Withhold IS (MTX) | Cohort E, Arm E4: Sanofi-GSK + Withhold IS (MTX) | Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT) | Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (BCDT) | Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT) |
|---|---|---|---|---|---|---|---|
| Percent of Stage 2 Adult Participants Who Experience Any Serious Adverse Events (SAEs) | 1 | 1 | 0 | 0 | 6 | 0 | 1 |
Medically attended adverse event (MAAE) is defined as a hospitalization, emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason that is considered possibly related or related to study vaccine.
| Participants | Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Cohort C, Arm C3: Janssen + Continue IS (BCDT) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Percent of Stage 1 Adult Participants Who Experience Any Medically Attended Adverse Events (MAAEs) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Medically attended adverse event (MAAE) is defined as a hospitalization, emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason that is considered possibly related or related to study vaccine.
| Participants | Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA) | Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA) | Cohort E, Arm E2: Alternative mRNA + Withhold IS (MTX) | Cohort E, Arm E4: Sanofi-GSK + Withhold IS (MTX) | Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT) | Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (BCDT) | Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT) |
|---|---|---|---|---|---|---|---|
| Percent of Stage 2 Adult Participants Who Experience Any Medically Attended Adverse Events (MAAEs) | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
A new onset chronic medical condition (NOCMC) is defined as any new ICD diagnosis (per current International Statistical Classification of Diseases and Related Health Problems) that is applied to the study participant during the course of the study, after receipt of the vaccine, that is expected to continue for at least 3 months and requires continued health care intervention.
| Participants | Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Cohort C, Arm C3: Janssen + Continue IS (BCDT) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Percent of Stage 1 Adult Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 5 | 0 |
A new onset chronic medical condition (NOCMC) is defined as any new ICD diagnosis (per current International Statistical Classification of Diseases and Related Health Problems) that is applied to the study participant during the course of the study, after receipt of the vaccine, that is expected to continue for at least 3 months and requires continued health care intervention.
| Participants | Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA) | Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA) | Cohort E, Arm E2: Alternative mRNA + Withhold IS (MTX) | Cohort E, Arm E4: Sanofi-GSK + Withhold IS (MTX) | Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT) | Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (BCDT) | Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT) |
|---|---|---|---|---|---|---|---|
| Percent of Stage 2 Adult Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs) | 0 | 0 | 0 | 0 | 2 | 0 | 1 |
Efficacy measure.
| Participants | Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Cohort C, Arm C3: Janssen + Continue IS (BCDT) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Percent of Stage 1 Adult Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection | 1 | 0 | 3 | 3 | 0 | 1 | 0 | 3 | 6 | 14 | 12 | 6 |
COVID-19 infections (all grades) were confirmed by molecular COVID-19 testing. AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 24.0.
| Participants | Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA) | Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA) | Cohort E, Arm E2: Alternative mRNA + Withhold IS (MTX) | Cohort E, Arm E4: Sanofi-GSK + Withhold IS (MTX) | Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT) | Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (BCDT) | Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT) |
|---|---|---|---|---|---|---|---|
| Percent of Stage 2 Adult Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection | 2 | 1 | 1 | 3 | 20 | 0 | 6 |
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center Meso Scale Discovery 3 plex assay. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing antibody data were considered missing-completely-at-random. Seroconversion was assessed in the subgroup of participants who were anti-COVID-19 antibody negative at Week 0; defined as a result less than or equal to the positive threshold value (spike=10.8424, RBD=14.0858), defined independently for spike and RBD. Seroconversion was defined as having a result greater than the positive threshold at the Week 4 visit.
| Participants | Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA) |
|---|---|
| Percentage of Stage 2 Pediatric Participants Who Seroconverted | 0 |
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center Meso Scale Discovery 3 plex assay. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing antibody data were considered missing-completely-at-random. Fold increase was assessed in the subgroup of participants who were anti-COVID-19 antibody positive at Week 0; defined as having a result greater than the positive threshold value (spike=10.8424, RBD=14.0858), defined independently for spike and RBD. Fold increase = (antibody response at Week 4)/(antibody response at Week 0).
| Fold Change | Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX) |
|---|---|
| Fold Change, Wu-1 Full-Length Spike | 149.84 ± NA |
| Fold Change, Receptor Binding Domain (RBD) | 112.05 ± NA |
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) 3 plex assay (Wu-1 full-length spike, receptor binding domain (RBD), and N proteins). Wu-1 full-length spike and RBD were used to assess vaccine response. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing anti-COVID-19 antibody response data were considered to be missing-completely-at-random.
| IU/mL | Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA) | Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX) |
|---|---|---|
| Week 0, Wu-1 Full-Length Spike | 1.27 ± NA | 123.28 ± NA |
| Week 4, Wu-1 Full-Length Spike | 6.53 ± NA | 18473.06 ± NA |
| Week 12, Wu-1 Full-Length Spike | — | 3583.89 ± NA |
| Week 0, Receptor Binding Domain (RBD) | 2.49 ± NA | 175.7 ± NA |
| Week 4, Receptor Binding Domain (RBD) | 10.65 ± NA | 19688.14 ± NA |
| Week 12, Receptor Binding Domain (RBD) | — | 3664.63 ± NA |
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) V-Plex ACE2 neutralization assay which measure antibodies that block the binding of angiotensin-converting enzyme 2 (ACE2) to the SARS-CoV-2 Spike antigens, including variants of the SARS-CoV-2 virus according to the manufacturer's instruction (MSD Catalog # K15654U). Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing anti-COVID-19 antibody response data were considered to be missing-completely-at-random. Results are reported as fold inhibition by a sample relative to signal from a 'diluent only' control (maximum ACE2 binding to antigen). Highly neutralizing samples show high fold inhibition whereas negative or low samples show low fold inhibition of ACE2 binding.
| Fold Inhibition | Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA) | Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX) |
|---|---|---|
| Week 0 | 1 ± NA | 1 ± NA |
| Week 4 | 1 ± NA | 722 ± NA |
| Week 12 | — | 158 ± NA |
The Clinical Global Impression of Change (CGI-C) is the clinician's global impression of a participant's clinical condition in terms of change relative to the start of treatment. Change is rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
| Participants | Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA) | Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX) |
|---|---|---|
| Very much improved | 0 | 0 |
| Much improved | 0 | 0 |
| Minimally improved | 0 | 0 |
| No change | 1 | 0 |
| Minimally worse | 0 | 1 |
| Much worse | 0 | 0 |
| Very much worse | 0 | 0 |
The Physician's Global Assessment of the participant's current disease activity is assessed on a 10 cm linear horizontal visual analog scale, where the left hand extreme of the line is considered "Very Good" (0 cm, no disease activity) and the right hand extreme is considered "Very Bad" (10 cm, severe disease activity).
| cm | Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA) | Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX) |
|---|---|---|
| Week 0 | 0 ± NA | 0.8 ± NA |
| Week 4 | 0 ± NA | 0.6 ± NA |
| Week 12 | 0 ± NA | 0.4 ± NA |
The Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K is a validated, physician-based assessment tool used to measure the extent of lupus disease activity within the past 28 days. SLEDAI-2K total score is a weighted sum of the presence of 24 lupus disease symptoms and ranges from 0 to 105, with higher scores indicating more lupus disease activity present.
| SLEDAI-2K Score | Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA) |
|---|---|
| Week 0 | 2 ± NA |
| Week 4 | 2 ± NA |
| Week 12 | 0 ± NA |
The Patient Global Assessment of the participant's current disease activity is assessed on a 10 cm linear horizontal visual analog scale, where the left hand extreme of the line is considered "Very Good" (0 cm, no disease activity) and the right hand extreme is considered "Very Bad" (10 cm, severe disease activity).
| cm | Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA) | Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX) |
|---|---|---|
| Week 0 | 5 ± NA | 0 ± NA |
| Week 4 | 5 ± NA | 0 ± NA |
| Week 12 | 5 ± NA | 0 ± NA |
The Patient Global Impression of Change (PGI-C) is the participant's global impression of their clinical condition in terms of change relative to the start of treatment. Change is rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
| Participants | Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA) | Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX) |
|---|---|---|
| Very much improved | 0 | 0 |
| Much improved | 0 | 0 |
| Minimally improved | 0 | 0 |
| No change | 1 | 1 |
| Minimally worse | 0 | 0 |
| Much worse | 0 | 0 |
| Very much worse | 0 | 0 |
All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation. All AEs were classified by system organ class (SOC) and preferred term, according to a standardized thesaurus (Medical Dictionary for Regulatory Activities \[MedDRA\] version 24.0. Related AEs were defined as "possibly related" (the AE has a reasonable possibility to be related; there is evidence to suggest a causal relationship) or "related" (the adverse event is clearly related). Severity was assessed according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
| Participants | Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA) | Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX) |
|---|---|---|
| Percent of Stage 2 Pediatric Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine | 0 | 0 |
An event is considered "serious" if, in the view of either the investigator or Sponsor, it results in any of the following: 1. Death. 2. Life-threatening event: considered "life-threatening" if, in the view of either the investigator or Sponsor, its occurrence places the participant at immediate risk of death. It does not include an AE that, had it occurred in a more severe form, might have caused death. 3. Inpatient hospitalization or prolongation of existing hospitalization. 4. Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. 5. Congenital anomaly or birth defect. 6. Important medical events that may not result in death, be life threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above.
| Participants | Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA) | Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX) |
|---|---|---|
| Percent of Stage 2 Pediatric Participants Who Experience Any Serious Adverse Events (SAEs) | 0 | 0 |
Medically attended adverse event (MAAE) is defined as a hospitalization, emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason that is considered possibly related or related to study vaccine.
| Participants | Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA) | Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX) |
|---|---|---|
| Percent of Stage 2 Pediatric Participants Who Experience Any Medically Attended Adverse Events (MAAEs) | 0 | 0 |
A new onset chronic medical condition (NOCMC) is defined as any new ICD diagnosis (per current International Statistical Classification of Diseases and Related Health Problems) that is applied to the study participant during the course of the study, after receipt of the vaccine, that is expected to continue for at least 3 months and requires continued health care intervention.
| Participants | Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA) | Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX) |
|---|---|---|
| Percent of Stage 2 Pediatric Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs) | 0 | 0 |
COVID-19 infections (all grades) were confirmed by molecular COVID-19 testing. AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 24.0.
| Participants | Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA) | Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX) |
|---|---|---|
| Percent of Stage 2 Pediatric Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection | 0 | 0 |
Collected over All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation (up to Week 48).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | 0/2 (0%) | 0/2 (0%) | 1/2 (50%) |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | 0/8 (0%) | 0/8 (0%) | 3/8 (37.5%) |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | 0/9 (0%) | 0/9 (0%) | 4/9 (44.4%) |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | 0/2 (0%) | 1/2 (50%) | 0/2 (0%) |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | 0/3 (0%) | 0/3 (0%) | 2/3 (66.7%) |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | 0/10 (0%) | 0/10 (0%) | 3/10 (30%) |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | 0/10 (0%) | 1/10 (10%) | 5/10 (50%) |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | 0/40 (0%) | 5/40 (12.5%) | 15/40 (37.5%) |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | 0/45 (0%) | 4/45 (8.9%) | 12/45 (26.7%) |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | 0/8 (0%) | 0/8 (0%) | 6/8 (75%) |
| Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA) | 0/9 (0%) | 1/9 (11.1%) | 5/9 (55.6%) |
| Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA) | 0/5 (0%) | 1/5 (20%) | 2/5 (40%) |
| Cohort E, Arm E2: Alternative mRNA + Withhold IS (MTX) | 0/8 (0%) | 0/8 (0%) | 3/8 (37.5%) |
| Cohort E, Arm E4: Sanofi-GSK + Withhold IS (MTX) | 0/6 (0%) | 0/6 (0%) | 4/6 (66.7%) |
| Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT) | 0/53 (0%) | 6/53 (11.3%) | 20/53 (37.7%) |
| Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (BCDT) | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT) | 0/20 (0%) | 1/20 (5%) | 9/20 (45%) |
| Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA) | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX) | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Event | Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA) | Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA) | Cohort E, Arm E2: Alternative mRNA + Withhold IS (MTX) | Cohort E, Arm E4: Sanofi-GSK + Withhold IS (MTX) | Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT) | Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (BCDT) | Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT) | Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA) | Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cardiac failure acuteCardiac disorders | 0/2 | 0/1 | 0/8 | 0/9 | 1/2 | 0/3 | 0/3 | 0/10 | 0/10 | 0/40 | 0/45 | 0/8 | 0/9 | 0/5 | 0/8 | 0/6 | 0/53 | 0/2 | 0/20 | 0/1 | 0/1 |
| Acute myocardial infarctionCardiac disorders | 0/2 | 0/1 | 0/8 | 0/9 | 0/2 | 0/3 | 0/3 | 0/10 | 0/10 | 0/40 | 0/45 | 0/8 | 0/9 | 1/5 | 0/8 | 0/6 | 0/53 | 0/2 | 0/20 | 0/1 | 0/1 |
| Urinary tract infectionInfections and infestations | 0/2 | 0/1 | 0/8 | 0/9 | 0/2 | 0/3 | 0/3 | 0/10 | 0/10 | 0/40 | 0/45 | 0/8 | 1/9 | 0/5 | 0/8 | 0/6 | 0/53 | 0/2 | 0/20 | 0/1 | 0/1 |
| COVID-19Infections and infestations | 0/2 | 0/1 | 0/8 | 0/9 | 0/2 | 0/3 | 0/3 | 0/10 | 1/10 | 0/40 | 0/45 | 0/8 | 0/9 | 0/5 | 0/8 | 0/6 | 0/53 | 0/2 | 0/20 | 0/1 | 0/1 |
| Herpes zosterInfections and infestations | 0/2 | 0/1 | 0/8 | 0/9 | 0/2 | 0/3 | 0/3 | 0/10 | 0/10 | 0/40 | 0/45 | 0/8 | 0/9 | 0/5 | 0/8 | 0/6 | 0/53 | 0/2 | 1/20 | 0/1 | 0/1 |
| Cardiomyopathy alcoholicCardiac disorders | 0/2 | 0/1 | 0/8 | 0/9 | 0/2 | 0/3 | 0/3 | 0/10 | 0/10 | 1/40 | 0/45 | 0/8 | 0/9 | 0/5 | 0/8 | 0/6 | 0/53 | 0/2 | 0/20 | 0/1 | 0/1 |
| Pulmonary malformationCongenital, familial and genetic disorders | 0/2 | 0/1 | 0/8 | 0/9 | 0/2 | 0/3 | 0/3 | 0/10 | 0/10 | 1/40 | 0/45 | 0/8 | 0/9 | 0/5 | 0/8 | 0/6 | 0/53 | 0/2 | 0/20 | 0/1 | 0/1 |
| Pneumonia bacterialInfections and infestations | 0/2 | 0/1 | 0/8 | 0/9 | 0/2 | 0/3 | 0/3 | 0/10 | 0/10 | 1/40 | 0/45 | 0/8 | 0/9 | 0/5 | 0/8 | 0/6 | 0/53 | 0/2 | 0/20 | 0/1 | 0/1 |
| Uhthoff's phenomenonNervous system disorders | 0/2 | 0/1 | 0/8 | 0/9 | 0/2 | 0/3 | 0/3 | 0/10 | 0/10 | 1/40 | 0/45 | 0/8 | 0/9 | 0/5 | 0/8 | 0/6 | 0/53 | 0/2 | 0/20 | 0/1 | 0/1 |
| PemphigusSkin and subcutaneous tissue disorders | 0/2 | 0/1 | 0/8 | 0/9 | 0/2 | 0/3 | 0/3 | 0/10 | 0/10 | 1/40 | 0/45 | 0/8 | 0/9 | 0/5 | 0/8 | 0/6 | 0/53 | 0/2 | 0/20 | 0/1 | 0/1 |
| Event | Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA) | Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA) | Cohort E, Arm E2: Alternative mRNA + Withhold IS (MTX) | Cohort E, Arm E4: Sanofi-GSK + Withhold IS (MTX) | Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT) | Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (BCDT) | Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT) | Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA) | Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| COVID-19Infections and infestations | 1/2 | 0/1 | 3/8 | 3/9 | 0/2 | 1/3 | 0/3 | 3/10 | 5/10 | 14/40 | 11/45 | 6/8 | 2/9 | 1/5 | 1/8 | 3/6 | 20/53 | 0/2 | 6/20 | 0/1 | 0/1 |
| HypertensionVascular disorders | 0/2 | 0/1 | 0/8 | 0/9 | 0/2 | 1/3 | 0/3 | 0/10 | 0/10 | 0/40 | 1/45 | 0/8 | 0/9 | 0/5 | 0/8 | 0/6 | 0/53 | 0/2 | 0/20 | 0/1 | 0/1 |
| Viral upper respiratory tract infectionInfections and infestations | 0/2 | 0/1 | 0/8 | 0/9 | 0/2 | 0/3 | 0/3 | 0/10 | 0/10 | 0/40 | 0/45 | 0/8 | 0/9 | 1/5 | 0/8 | 0/6 | 0/53 | 0/2 | 0/20 | 0/1 | 0/1 |
| Injection site indurationGeneral disorders | 0/2 | 0/1 | 0/8 | 0/9 | 0/2 | 0/3 | 0/3 | 0/10 | 0/10 | 0/40 | 0/45 | 0/8 | 0/9 | 0/5 | 0/8 | 1/6 | 0/53 | 0/2 | 0/20 | 0/1 | 0/1 |
| Injection site painGeneral disorders | 0/2 | 0/1 | 0/8 | 0/9 | 0/2 | 0/3 | 0/3 | 0/10 | 0/10 | 0/40 | 0/45 | 0/8 | 0/9 | 0/5 | 0/8 | 1/6 | 0/53 | 0/2 | 0/20 | 0/1 | 0/1 |
| Injection site swellingGeneral disorders | 0/2 | 0/1 | 0/8 | 0/9 | 0/2 | 0/3 | 0/3 | 0/10 | 0/10 | 0/40 | 0/45 | 0/8 | 0/9 | 0/5 | 0/8 | 1/6 | 0/53 | 0/2 | 0/20 | 0/1 | 0/1 |
| TachycardiaCardiac disorders | 0/2 | 0/1 | 1/8 | 0/9 | 0/2 | 0/3 | 0/3 | 0/10 | 0/10 | 0/40 | 0/45 | 0/8 | 1/9 | 0/5 | 0/8 | 0/6 | 0/53 | 0/2 | 0/20 | 0/1 | 0/1 |
| Herpes zosterInfections and infestations | 0/2 | 0/1 | 1/8 | 0/9 | 0/2 | 0/3 | 0/3 | 0/10 | 0/10 | 0/40 | 0/45 | 0/8 | 0/9 | 0/5 | 0/8 | 0/6 | 0/53 | 0/2 | 0/20 | 0/1 | 0/1 |
| Oral herpesInfections and infestations | 0/2 | 0/1 | 0/8 | 0/9 | 0/2 | 0/3 | 0/3 | 0/10 | 0/10 | 0/40 | 0/45 | 0/8 | 0/9 | 0/5 | 1/8 | 0/6 | 0/53 | 0/2 | 0/20 | 0/1 | 0/1 |
| PneumoniaInfections and infestations | 0/2 | 0/1 | 0/8 | 0/9 | 0/2 | 0/3 | 0/3 | 0/10 | 0/10 | 0/40 | 0/45 | 0/8 | 0/9 | 0/5 | 1/8 | 0/6 | 0/53 | 0/2 | 0/20 | 0/1 | 0/1 |
Randomized or allocated to study arms for Stage 1, Stage 2 and Stage 2 Sanofi.
| Age, Categorical(Participants) | Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA) | Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA) | Cohort E, Arm E2: Alternative mRNA + Withhold IS (MTX) | Cohort E, Arm E4: Sanofi-GSK + Withhold IS (MTX) | Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT) | Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (BCDT) | Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT) | Cohort F, Arm F1: Janssen + Withhold IS (BCDT) | Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA) | Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Stage 1 — <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | — | — | — | — | — | — | — | — | — | — | 1 |
| Stage 1 — Between 18 and 65 years | 2 | 2 | 6 | 9 | 2 | 0 | 1 | 6 | 4 | 33 | 40 | 8 | — | — | — | — | — | — | — | — | — | — | 113 |
| Stage 1 — >=65 years | 0 | 0 | 3 | 1 | 0 | 3 | 2 | 5 | 7 | 8 | 4 | 1 | — | — | — | — | — | — | — | — | — | — | 34 |
| Stage 2 — <=18 years | — | — | — | — | — | — | — | — | — | — | — | — | 0 | — | 0 | — | 1 | 0 | — | 0 | 1 | 1 | 3 |
| Stage 2 — Between 18 and 65 years | — | — | — | — | — | — | — | — | — | — | — | — | 6 | — | 6 | — | 47 | 2 | — | 1 | 0 | 0 | 62 |
| Stage 2 — >=65 years | — | — | — | — | — | — | — | — | — | — | — | — | 3 | — | 2 | — | 9 | 0 | — | 0 | 0 | 0 | 14 |
| Stage 2 Sanofi — <=18 years | — | — | — | — | — | — | — | — | — | — | — | — | — | 0 | — | 0 | — | — | 0 | — | — | — | 0 |
| Stage 2 Sanofi — Between 18 and 65 years | — | — | — | — | — | — | — | — | — | — | — | — | — | 3 | — | 4 | — | — | 16 | — | — | — | 23 |
| Stage 2 Sanofi — >=65 years | — | — | — | — | — | — | — | — | — | — | — | — | — | 2 | — | 2 | — | — | 4 | — | — | — | 8 |
| Age, Continuous(years) | Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA) | Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA) | Cohort E, Arm E2: Alternative mRNA + Withhold IS (MTX) | Cohort E, Arm E4: Sanofi-GSK + Withhold IS (MTX) | Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT) | Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (BCDT) | Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT) | Cohort F, Arm F1: Janssen + Withhold IS (BCDT) | Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA) | Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Stage 1 | 62.0 ± 2.89 | 41.0 ± 9.90 | 50.4 ± 16.34 | 44.7 ± 13.12 | 59.5 ± 0.71 | 70.7 ± 5.69 | 64.7 ± 17.39 | 62.3 ± 7.98 | 66.0 ± 9.96 | 51.3 ± 14.81 | 45.4 ± 13.02 | 55.1 ± 7.15 | — | — | — | — | — | — | — | — | — | — | 51.9 ± 14.46 |
| Stage 2 | — | — | — | — | — | — | — | — | — | — | — | — | 51.4 ± 16.46 | — | 62.4 ± 4.66 | — | 51.1 ± 13.41 | 54.0 ± 5.66 | — | 54.0 ± NA | 17.0 ± NA | 12.0 ± NA | 51.5 ± 14.39 |
| Stage 2 Sanofi | — | — | — | — | — | — | — | — | — | — | — | — | — | 51.6 ± 19.86 | — | 63.0 ± 9.19 | — | — | 52.9 ± 11.09 | — | — | — | 54.7 ± 12.73 |
| Sex: Female, Male(Participants) | Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA) | Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA) | Cohort E, Arm E2: Alternative mRNA + Withhold IS (MTX) | Cohort E, Arm E4: Sanofi-GSK + Withhold IS (MTX) | Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT) | Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (BCDT) | Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT) | Cohort F, Arm F1: Janssen + Withhold IS (BCDT) | Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA) | Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Stage 1 — Female | 2 | 2 | 8 | 9 | 2 | 2 | 3 | 11 | 10 | 27 | 35 | 5 | — | — | — | — | — | — | — | — | — | — | 116 |
| Stage 1 — Male | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 1 | 14 | 10 | 4 | — | — | — | — | — | — | — | — | — | — | 32 |
| Stage 2 — Female | — | — | — | — | — | — | — | — | — | — | — | — | 9 | — | 6 | — | 43 | 1 | — | 1 | 1 | 1 | 62 |
| Stage 2 — Male | — | — | — | — | — | — | — | — | — | — | — | — | 0 | — | 2 | — | 14 | 1 | — | 0 | 0 | 0 | 17 |
| Stage 2 Sanofi — Female | — | — | — | — | — | — | — | — | — | — | — | — | — | 5 | — | 4 | — | — | 19 | — | — | — | 28 |
| Stage 2 Sanofi — Male | — | — | — | — | — | — | — | — | — | — | — | — | — | 0 | — | 2 | — | — | 1 | — | — | — | 3 |
| Ethnicity (NIH/OMB)(Participants) | Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA) | Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA) | Cohort E, Arm E2: Alternative mRNA + Withhold IS (MTX) | Cohort E, Arm E4: Sanofi-GSK + Withhold IS (MTX) | Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT) | Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (BCDT) | Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT) | Cohort F, Arm F1: Janssen + Withhold IS (BCDT) | Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA) | Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Stage 1 — Hispanic or Latino | 1 | 0 | 2 | 2 | 1 | 0 | 1 | 0 | 2 | 1 | 5 | 1 | — | — | — | — | — | — | — | — | — | — | 16 |
| Stage 1 — Not Hispanic or Latino | 1 | 2 | 7 | 8 | 1 | 3 | 2 | 11 | 9 | 40 | 40 | 8 | — | — | — | — | — | — | — | — | — | — | 132 |
| Stage 1 — Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | — | — | — | — | — | — | — | — | — | — | 0 |
| Stage 2 — Hispanic or Latino | — | — | — | — | — | — | — | — | — | — | — | — | 1 | — | 0 | — | 4 | 0 | — | 0 | 0 | 0 | 5 |
| Stage 2 — Not Hispanic or Latino | — | — | — | — | — | — | — | — | — | — | — | — | 8 | — | 8 | — | 53 | 2 | — | 1 | 1 | 1 | 74 |
| Stage 2 — Unknown or Not Reported | — | — | — | — | — | — | — | — | — | — | — | — | 0 | — | 0 | — | 0 | 0 | — | 0 | 0 | 0 | 0 |
| Stage 2 Sanofi — Hispanic or Latino | — | — | — | — | — | — | — | — | — | — | — | — | — | 0 | — | 0 | — | — | 0 | — | — | — | 0 |
| Stage 2 Sanofi — Not Hispanic or Latino | — | — | — | — | — | — | — | — | — | — | — | — | — | 5 | — | 6 | — | — | 20 | — | — | — | 31 |
| Stage 2 Sanofi — Unknown or Not Reported | — | — | — | — | — | — | — | — | — | — | — | — | — | 0 | — | 0 | — | — | 0 | — | — | — | 0 |
| Race (NIH/OMB)(Participants) | Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA) | Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA) | Cohort E, Arm E2: Alternative mRNA + Withhold IS (MTX) | Cohort E, Arm E4: Sanofi-GSK + Withhold IS (MTX) | Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT) | Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (BCDT) | Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT) | Cohort F, Arm F1: Janssen + Withhold IS (BCDT) | Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA) | Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Stage 1 — American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | — | — | — | — | — | — | — | — | — | — | 1 |
| Stage 1 — Asian | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | — | — | — | — | — | — | — | — | — | — | 3 |
| Stage 1 — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | — | — | — | — | — | — | — | — | — | — | 0 |
| Stage 1 — Black or African American | 0 | 2 | 3 | 6 | 1 | 0 | 1 | 2 | 3 | 2 | 8 | 2 | — | — | — | — | — | — | — | — | — | — | 30 |
| Stage 1 — White | 2 | 0 | 6 | 3 | 1 | 3 | 1 | 7 | 6 | 38 | 35 | 7 | — | — | — | — | — | — | — | — | — | — | 109 |
| Stage 1 — More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | — | — | — | — | — | — | — | — | — | — | 2 |
| Stage 1 — Unknown or Not Reported | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | — | — | — | — | — | — | — | — | — | — | 3 |
| Stage 2 — American Indian or Alaska Native | — | — | — | — | — | — | — | — | — | — | — | — | 0 | — | 0 | — | 0 | 0 | — | 0 | 0 | 0 | 0 |
| Stage 2 — Asian | — | — | — | — | — | — | — | — | — | — | — | — | 0 | — | 0 | — | 1 | 0 | — | 0 | 1 | 0 | 2 |
| Stage 2 — Native Hawaiian or Other Pacific Islander | — | — | — | — | — | — | — | — | — | — | — | — | 0 | — | 0 | — | 0 | 0 | — | 0 | 0 | 0 | 0 |
| Stage 2 — Black or African American | — | — | — | — | — | — | — | — | — | — | — | — | 2 | — | 0 | — | 6 | 0 | — | 1 | 0 | 0 | 9 |
| Stage 2 — White | — | — | — | — | — | — | — | — | — | — | — | — | 6 | — | 8 | — | 48 | 2 | — | 0 | 0 | 1 | 65 |
| Stage 2 — More than one race | — | — | — | — | — | — | — | — | — | — | — | — | 0 | — | 0 | — | 0 | 0 | — | 0 | 0 | 0 | 0 |
| Stage 2 — Unknown or Not Reported | — | — | — | — | — | — | — | — | — | — | — | — | 1 | — | 0 | — | 2 | 0 | — | 0 | 0 | 0 | 3 |
| Stage 2 Sanofi — American Indian or Alaska Native | — | — | — | — | — | — | — | — | — | — | — | — | — | 0 | — | 0 | — | — | 0 | — | — | — | 0 |
| Stage 2 Sanofi — Asian | — | — | — | — | — | — | — | — | — | — | — | — | — | 1 | — | 0 | — | — | 1 | — | — | — | 2 |
| Stage 2 Sanofi — Native Hawaiian or Other Pacific Islander | — | — | — | — | — | — | — | — | — | — | — | — | — | 0 | — | 0 | — | — | 0 | — | — | — | 0 |
| Stage 2 Sanofi — Black or African American | — | — | — | — | — | — | — | — | — | — | — | — | — | 1 | — | 0 | — | — | 2 | — | — | — | 3 |
| Stage 2 Sanofi — White | — | — | — | — | — | — | — | — | — | — | — | — | — | 3 | — | 6 | — | — | 17 | — | — | — | 26 |
| Stage 2 Sanofi — More than one race | — | — | — | — | — | — | — | — | — | — | — | — | — | 0 | — | 0 | — | — | 0 | — | — | — | 0 |
| Stage 2 Sanofi — Unknown or Not Reported | — | — | — | — | — | — | — | — | — | — | — | — | — | 0 | — | 0 | — | — | 0 | — | — | — | 0 |
| Region of Enrollment(Participants) | Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA) | Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA) | Cohort E, Arm E2: Alternative mRNA + Withhold IS (MTX) | Cohort E, Arm E4: Sanofi-GSK + Withhold IS (MTX) | Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT) | Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (BCDT) | Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT) | Cohort F, Arm F1: Janssen + Withhold IS (BCDT) | Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA) | Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States — Stage 1 | 2 | 2 | 9 | 10 | 2 | 3 | 3 | 11 | 11 | 41 | 45 | 9 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 148 |
| United States — Stage 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 9 | 0 | 8 | 0 | 57 | 2 | 0 | 1 | 1 | 1 | 79 |
| United States — Stage 2 Sanofi | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 0 | 6 | 0 | 0 | 20 | 0 | 0 | 0 | 31 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — The plan is to share data upon completion of the study in: Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
Time frame: On average, within 24 months after database lock for the trial.
Access criteria: Open access.
Data sharing details ↗ · www.immport.org
Ran from Aug 2021 to primary completion in Jun 2023, 22 months.
Results were first posted in Aug 2025, 2 years 2 months after primary completion. A results delay was requested in Feb 2024.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: 2019-nCoV Vaccine mRNA-1273 · BNT162 Vaccine · Ad26COVS1 · Mycophenolic Acid · Methotrexate
National Institute of Allergy and Infectious Diseases (NIAID) →