A Phase 1/2 interventional study of CoTend-BXBB (SARS2-30404) and CoTend-s3BXBB (SARS2-17032) in COVID-19 and SARS-CoV-2 Infection, sponsored by Kara Chew. Recruiting at 2 sites in United States. Open to participants aged 40 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Kara Chew · Phase 1/2, Interventional, and Prevention
The goal of this clinical trial is to test two investigational COVID-19 booster vaccines, called CoTend-s3BXBB and CoTend-BXBB, in healthy volunteers ages 40-64. The CoTend-s3BXBB vaccine includes a component called "s3", which was designed to improve the body's response to the vaccine. CoTend-BXBB is the same vaccine without s3.
The main questions the study aims to answer are: 1) Is the investigational vaccine safe? 2) Does "s3" lead to bigger, broader, and longer-lasting responses to the vaccine?
5 different doses of the vaccines will be studied. Participants will receive a single dose of either CoTend-s3BXBB, CoTend-BXBB, or placebo. Participants will be monitored for side effects. Saliva, nasal, and blood samples will be collected and immune responses to the vaccine will be measured.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's planned enrollment of 80 is below the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →This is the only study on the registry with Kara Chew as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The following laboratory criteria must be met at screening:
Individuals of must have a negative serum or urine beta-human chorionic gonadotropin (ß-HCG) test at screening and within 48 hours prior to entry.
Reproductive potential is defined as:
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria are met:
For participants capable of becoming pregnant and engaging in sexual activity that can lead to pregnancy, unwillingness to use during participation in the study. For participants capable of becoming pregnant, two of the following forms of contraception are required through 30 days following administration of study intervention, one of which must be a barrier method:
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.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
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).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
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.
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.
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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
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.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
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.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
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.
Intervention: CoTend-s3BXBB (SARS2-17032) Dose: 1x10\^6 vp (0.5mL) IM once
Biological: CoTend-s3BXBB (SARS2-17032)
Intervention: CoTend-BXBB (SARS2-30404) Dose: 1x10\^6 vp (0.5mL) IM once
Biological: CoTend-BXBB (SARS2-30404)
Intervention: CoTend-s3BXBB (SARS2-17032) Dose: 1x10\^7 vp (0.5mL) IM once
Biological: CoTend-s3BXBB (SARS2-17032)
Intervention: CoTend-BXBB (SARS2-30404) Dose: 1x10\^7 vp (0.5mL) IM once
Biological: CoTend-BXBB (SARS2-30404)
Intervention: CoTend-s3BXBB (SARS2-17032) Dose: 1x10\^8 vp (0.5mL) IM once
Biological: CoTend-s3BXBB (SARS2-17032)
Intervention: CoTend-BXBB (SARS2-30404) Dose: 1x10\^8 vp (0.5mL) IM once
Biological: CoTend-BXBB (SARS2-30404)
Intervention: CoTend-s3BXBB (SARS2-17032) Dose: 1x10\^9 vp (0.5mL) IM once
Biological: CoTend-s3BXBB (SARS2-17032)
Intervention: CoTend-BXBB (SARS2-30404) Dose: 1x10\^9 vp (0.5mL) IM once
Biological: CoTend-BXBB (SARS2-30404)
Intervention: CoTend-s3BXBB (SARS2-17032) Dose: 1x10\^10 vp (0.5mL) IM once
Biological: CoTend-s3BXBB (SARS2-17032)
Intervention: CoTend-BXBB (SARS2-30404) Dose: 1x10\^10 vp (0.5mL) IM once
Biological: CoTend-BXBB (SARS2-30404)
Intervention: CoTend-s3BXBB (SARS2-17032) Dose: 1x10\^9 vp (0.5mL) IM once
Biological: CoTend-s3BXBB (SARS2-17032)
Intervention: CoTend-BXBB (SARS2-30404) Dose: 1x10\^9 vp (0.5mL) IM once
Biological: CoTend-BXBB (SARS2-30404)
Intervention: Placebo (normal saline) Dose: 0.5mL IM once
Biological: Placebo
Intervention: CoTend-s3BXBB (SARS2-17032) Dose: 1x10\^10 vp (0.5mL) IM once
Biological: CoTend-s3BXBB (SARS2-17032)
Intervention: CoTend-BXBB (SARS2-30404) Dose: 1x10\^10 vp (0.5mL) IM once
Biological: CoTend-BXBB (SARS2-30404)
Intervention: Placebo (normal saline) Dose: 0.5mL IM once
Biological: Placebo
Ad35-vectored SARS-CoV-2 RBD (XBB.1.5) vaccine
Ad35-vectored s3-SARS-CoV-2 RBD (XBB.1.5) vaccine
Sterile sodium chloride 0.9% for injection, preservative free
Frequency of solicited local reactogenicity adverse events (AEs) within 7 days after dosing.
Number of participants with solicited local reactogenicity AEs (injection site pain, erythema, or swelling) within 7 days after dosing. An AE is any untoward medical occurrence in a clinical investigation of a patient administered a pharmaceutical product and that does not necessarily have a causal relationship with the treatment.
Time frame: 7 days
Frequency of solicited systemic reactogenicity AEs within 7 days after dosing.
Number of participants with solicited systemic reactogenicity AEs (malaise, participant-measured body temperature, fatigue, headache, chills, nausea, muscle aches/pain, joint pain) within 7 days after dosing.
Time frame: 7 days
Frequency of unsolicited AEs within 28 days after dosing.
Number of participants with unsolicited AEs within 28 days after dosing. Unsolicited AEs are AEs that were not pre-defined as solicited.
Time frame: 28 days
Frequency of serious adverse events (SAEs) within 28 days after dosing.
Number of participants with an SAE within 28 days after dosing. An SAE is defined as any adverse event that results in any of the following outcomes: death during a period of surveillance defined by the protocol, a life-threatening adverse experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. The following are also considered SAEs for this study: severe COVID-19, defined as COVID-19 requiring hospitalization or supplemental oxygen, myocarditis or pericarditis within 6 weeks of study vaccination, and acute or new onset thrombosis or thromboembolism within 60 days of vaccination.
Time frame: 28 days
Frequency of adverse events of special interest (AESIs) within 28 days after dosing.
Number of participants with AESIs. AESIs defined as: thrombotic or thromboembolic events, thrombosis with thrombocytopenia syndrome, immune thrombocytopenia, or capillary leak syndrome occurring within 60 days; new thrombocytopenia \<150 x 10\^9/L or below the lower laboratory limit of normal or worsening in grade of thrombocytopenia within 60 days after study vaccination; new D-dimer elevation \>2000 ng/mL within 60 days; laryngospasm, bronchospasm, or anaphylaxis assessed as at least possibly related; generalized urticaria assessed as related; any other grade allergic/ hypersensitivity reaction within 7 days; any ulceration, abscess, or necrosis at injection site assessed as possibly related; myocarditis or pericarditis occurring within 6 weeks; new diagnosis of Guillain-Barré syndrome occurring within 60 days; any new or worsened immune mediated medical condition; grade 3+ lab abnormality for which there is a reasonable possibility of causal relationship to study treatment.
Time frame: 28 days
Frequency of medically attended adverse events (MAAEs) within 28 days after dosing.
Number of participants with MAAEs (MAAE defined as an AE resulting in a hospitalization, emergency room visit, or otherwise unscheduled visit with medical personnel for any reason) within 28 days after dosing.
Time frame: 28 days
Geometric mean titers (GMTs) of serum anti-XBB.1.5 neutralizing antibodies (NAb) through week 8.
Serum anti-XBB.1.5 NAb GMT
Time frame: 8 weeks
Proportion of participants achieving serum anti-XBB.1.5 NAb titers of 1:250 or better through week 8.
Proportion of participants achieving serum anti-XBB.1.5 NAb titers of 1:250 or better
Time frame: 8 weeks
Geometric mean fold rise (GMFR) from pre-dose to week 8 in serum anti-XBB.1.5 NAb responses.
Geometric mean fold rise (GMFR) in serum anti-XBB.1.5 NAb levels
Time frame: Pre-dose to 8 weeks
Serum anti-D614G NAb GMTs through week 8.
Serum anti-D614G NAb GMTs
Time frame: 8 weeks
Serum anti-JN.1* NAb GMTs through week 8.
Serum anti-JN.1\* NAb GMTs (\*the most relevant SARS-CoV-2 variant at the time of analysis will be evaluated)
Time frame: 8 weeks
Proportion of participants achieving anti-D614G NAb titers of 1:250 or better through week 8.
Proportion of participants achieving anti-D614G NAb titers of 1:250 or better
Time frame: 8 weeks
Proportion of participants achieving anti-JN.1* NAb titers of 1:250 or better through week 8.
Proportion of participants achieving serum anti-JN.1\* NAb GMTs of 1:250 or better (\*the most relevant SARS-CoV-2 variant at the time of analysis will be evaluated).
Time frame: 8 weeks
GMFR from pre-dose to week 8 in serum anti-D614G NAb responses.
GMFR in serum anti-D614G NAb responses
Time frame: Pre-dose to 8 weeks
GMFR from pre-dose to week 8 in serum anti-JN.1* NAb responses.
GMFR in serum anti-JN.1\* NAb responses (\*the most relevant SARS-CoV-2 variant at the time of analysis will be evaluated).
Time frame: Pre-dose to 8 weeks
Serum anti-XBB.1.5 RBD IgG binding antibody (bAb) GMTs through week 8.
Serum anti-XBB.1.5 RBD IgG bAb GMTs
Time frame: 8 weeks
Serum anti-XBB.1.5 RBD IgA binding antibody GMTs through week 8.
Serum anti-XBB.1.5 RBD IgA bAb GMTs
Time frame: 8 weeks
Serum anti-D614G RBD IgG binding antibody (bAb) GMTs through week 8.
Serum anti-D614G RBD IgG bAb GMTs.
Time frame: 8 weeks
Serum anti-D614G RBD IgA binding antibody (bAb) GMTs through week 8.
Serum anti-D614G RBD IgA bAb GMTs through week 8.
Time frame: 8 weeks
Serum anti-JN.1* RBD IgG binding antibody (bAb) GMTs through week 8.
Serum anti-JN.1\* RBD IgG bAb GMTs (\*the most relevant SARS-CoV-2 variant at the time of analysis will be evaluated)
Time frame: 8 weeks
Serum anti-JN.1* RBD IgA binding antibody (bAb) GMTs through week 8.
Serum anti-JN.1\* RBD IgA bAb GMTs (\*the most relevant SARS-CoV-2 variant at the time of analysis will be evaluated)
Time frame: 8 weeks
Geometric mean fold rise (GMFR) from pre-dose to week 8 in serum anti-XBB.1.5 RBD IgG binding antibody responses.
Time frame: Pre-dose to 8 weeks
Geometric mean fold rise (GMFR) from pre-dose to week 8 in serum anti-XBB.1.5 RBD IgA binding antibody responses.
Time frame: Pre-dose to 8 weeks
Geometric mean fold rise (GMFR) from pre-dose to week 8 in serum anti-D614G RBD IgG binding antibody responses.
Time frame: Pre-dose to 8 weeks
Geometric mean fold rise (GMFR) from pre-dose to week 8 in serum anti-D614G RBD IgA binding antibody responses.
Time frame: Pre-dose to 8 weeks
Geometric mean fold rise (GMFR) from pre-dose to week 8 in serum anti-JN.1* RBD IgG binding antibody responses.
Time frame: Pre-dose to 8 weeks
Geometric mean fold rise (GMFR) from pre-dose to week 8 in serum anti-JN.1* RBD IgA binding antibody responses.
Time frame: Pre-dose to 8 weeks
Frequency of grade 3 or higher AEs through week 26 visit.
Number of participants with grade 3 or higher AEs through week 26 visit. Grade 3 AE is defined as severe symptoms causing inability to perform usual social and functional activities with intervention or hospitalization indicated. Grade 4 AE is defined as potentially life-threatening symptoms causing inability to perform basic self-care functions with intervention indicated to prevent permanent impairment, persistent disability, or death. All deaths related to an AE are classified as grade 5.
Time frame: 26 weeks
Frequency of SAEs through week 26 visit.
Number of participants with SAEs through week 26 visit.
Time frame: 26 weeks
Frequency of AESIs through week 26 visit.
Number of participants with AESIs through week 26 visit.
Time frame: 26 weeks
Frequency of MAAEs through week 26 visit.
Number of participants with MAAEs through week 26 visit
Time frame: 26 weeks
Frequency of SAEs through end of study visit
Number of participants with SAEs through their end of study visit
Time frame: Through end of study visit (52 or 104 weeks)
Frequency of AESIs through end of study visit
Number of participants with AESIs through their end of study visit
Time frame: Through end of study visit (52 or 104 weeks)
Frequency of MAAEs through end of study visit
Number of participants with MAAEs through their end of study visit
Time frame: Through end of study visit (52 or 104 weeks)
Fraction of RBD-specific CD4+ T cells through week 8.
Fraction of RBD-specific CD4+ T cells
Time frame: 8 weeks
Fraction of RBD-specific CD8+ T cells through week 8.
Fraction of RBD-specific CD8+ T cells
Time frame: 8 weeks
NAb GMTs through week 26.
Serum NAb GMTs
Time frame: 26 weeks
NAb GMTs through week 52.
Serum NAb GMTs
Time frame: 52 weeks
NAb GMTs through week 104.
Serum NAb GMTs
Time frame: 104 weeks
Binding Ab GMTs through week 26.
Serum binding Ab GMTs
Time frame: 26 weeks
Binding Ab GMTs through week 52.
Serum binding Ab GMTs
Time frame: 52 weeks
Binding Ab GMTs through week 104.
Serum binding Ab GMTs
Time frame: 104 weeks
Proportion of participants achieving NAb titers of 1:250 or better through week 26.
Proportion of participants achieving serum NAb titers of 1:250 or better
Time frame: 26 weeks
Proportion of participants achieving NAb titers of 1:250 or better through week 52.
Proportion of participants achieving serum NAb titers of 1:250 or better
Time frame: 52 weeks
Proportion of participants achieving NAb titers of 1:250 or better through week 104.
Proportion of participants achieving serum NAb titers of 1:250 or better
Time frame: 104 weeks
GMFR of NAb titers from pre-dose through week 26.
GMFR of serum NAb titers
Time frame: Pre-dose to 26 weeks
GMFR of NAb titers from pre-dose through week 52.
GMFR of serum NAb titers
Time frame: Pre-dose to 52 weeks
GMFR of NAb titers from pre-dose through week 104.
GMFR of serum NAb titers
Time frame: Pre-dose to 104 weeks
GMFR of binding Ab titers from pre-dose through week 26.
Time frame: Pre-dose to 26 weeks
GMFR of binding Ab titers from pre-dose through week 52.
Time frame: Pre-dose to 52 weeks
GMFR of binding Ab titers from pre-dose through week 104.
Time frame: Pre-dose to 104 weeks
Fraction of RBD-specific CD4+ T cells through week 26.
Fraction of RBD-specific CD4+ T cells
Time frame: 26 weeks
Fraction of RBD-specific CD4+ T cells through week 52.
Fraction of RBD-specific CD4+ T cells
Time frame: 52 weeks
Fraction of RBD-specific CD4+ T cells through week 104.
Fraction of RBD-specific CD4+ T cells
Time frame: 104 weeks
Fraction of RBD-specific CD8+ T cells through week 26.
Fraction of RBD-specific CD8+ T cells
Time frame: 26 weeks
Fraction of RBD-specific CD8+ T cells through week 52.
Fraction of RBD-specific CD8+ T cells
Time frame: 52 weeks
Fraction of RBD-specific CD8+ T cells through week 104.
Fraction of RBD-specific CD8+ T cells
Time frame: 104 weeks
Plan to share: Yes — De-identified data.
Time frame: After completion of the study analyses and publications.
Access criteria: There will be a managed access process with requirement of a data use agreement.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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