A Phase 2 interventional study of JYNNEOS in Monkeypox, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 8 sites in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-16.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Prevention
This study is a Phase 2 randomized, open-label, non-placebo controlled, multi-site clinical trial that will evaluate two intradermal (ID) regimens for Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine compared to the standard subcutaneous (SC) regimen in healthy, vaccinia-naïve adults 18 to 50 years of age, inclusive. At least 210 participants will be enrolled and randomized to one of three study arms. The two dose sparing strategies include one-fifth (2 x 10\^7) and one-tenth (1 x 10\^7) of the standard dose of MVA-BN administered ID on Day 1 and 29 (Arm 1 and 2, respectively). The comparator arm (Arm 3) will be the 2-dose standard (1 x 10\^8) MVA-BN SC regimen.
The study will enroll a 1:1:1 randomization allocation. Participants will not be stratified by clinical trial site, demographic characteristics or human immunodeficiency virus (HIV) infection status; however, these data will be collected during screening and enrollment. Each participant may be screened either in a separate visit in the 7 days prior to Day 1 or on Day 1.
The primary hypothesis involves a two-step hierarchical process. The study will first test non-inferiority of the 2 x 10\^7 ID regimen relative to 1 x 10\^8 SC (standard dose regimen). If the 2 x 10\^7 ID regimen is non-inferior to the standard dose regimen, hypothesis testing will proceed to test non-inferiority of the 1 x 10\^7 ID regimen relative to the standard dose regimen.
The primary objectives are: 1) to determine if peak humoral immune responses following an ID regimen of 2 x 10\^7 50% Tissue Culture Infectious Dose (TCID50) MVA-BN are non-inferior to the licensed regimen of 1 x 10\^8 MVA-BN administered SC; 2) to determine if peak humoral immune responses following an ID regimen of 1 x 10\^7 TCID50 MVA-BN are non-inferior to the licensed regimen of 1 x 10\^8 MVA-BN administered SC.
This study is a Phase 2 randomized, open-label, non-placebo controlled, multi-site clinical trial that will evaluate two intradermal (ID) regimens for Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine compared to the standard subcutaneous (SC) regimen. This study will enroll healthy, non-pregnant, non-breastfeeding adults 18 to 50 years old inclusive. Participants with stable medical conditions and well-controlled human immunodeficiency virus (HIV) infection can participate. At least 210 participants will be enrolled and randomized to one of three study arms. The two dose sparing strategies include one-fifth (2 x 10\^7) and one-tenth (1 x 10\^7) of the standard dose of MVA-BN administered ID on Day 1 and 29 (Arm 1 and 2, respectively). The comparator arm (Arm 3) will be the 2-dose standard (1 x 10\^8) MVA-BN SC regimen.
The study will enroll a 1:1:1 randomization allocation. Participants will not be stratified by clinical trial site, demographic characteristics or HIV infection status; however, these data will be collected during screening and enrollment. Each participant may be screened either in a separate visit in the 7 days prior to Day 1 or on Day 1.
The primary hypothesis involves a two-step hierarchical process. The study will first test non-inferiority of the 2 x 10\^7 ID regimen relative to 1 x 10\^8 SC (standard dose regimen). If the 2 x 10\^7 ID regimen is non-inferior to the standard dose regimen, hypothesis testing will proceed to test non-inferiority of the 1 x 10\^7 ID regimen relative to the standard dose regimen.
The primary objectives are: 1) to determine if peak humoral immune responses following an ID regimen of 2 x 10\^7 50% Tissue Culture Infectious Dose (TCID50) MVA-BN are non-inferior to the licensed regimen of 1 x 10\^8 MVA-BN administered SC; 2) to determine if peak humoral immune responses following an ID regimen of 1 x 10\^7 TCID50 MVA-BN are non-inferior to the licensed regimen of 1 x 10\^8 MVA-BN administered SC.
The secondary objectives are: 1) to determine if individual peak humoral immune responses following each ID regimen are non-inferior to the licensed regimen administered SC; 2) to evaluate humoral immune responses of each ID regimen (separately) compared to licensed SC regimen each study day; 3) to evaluate the kinetics of the humoral immune responses of each ID regimen (separately) compared to licensed SC regimen through Day 365; 4) To compare relative safety among study arms as assessed by systemic and local reactogenicity for 14 days after each vaccination, unsolicited adverse events for 28 days after each vaccination, and serious adverse events (SAE) and medically attended events (MAAE) from Day 1 through Day 57, and related SAE/MAAEs through Day 181.
72 studies on the registry are indexed under Mpox, Monkeypox; 30 are open to participants now.
This study's enrollment of 229 is below the median of 305 across 36 interventional studies indexed under Mpox, Monkeypox.
Browse Mpox, Monkeypox 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.
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.
In good general health as evidenced by medical history, physical examination, and clinical judgement of the investigator to be in stable state of health.
*Participants with pre-existing stable chronic medical conditions defined as conditions not requiring significant change in therapy or hospitalization for worsening disease in the 4 weeks prior to enrollment can be included at the discretion of the investigator. This includes stable, well-controlled positive individuals.
Exclusion Criteria:
Ever received a licensed or an smallpox or monkeypox vaccine.
*This includes Dryvax, Acam2000, LC 16 m8, Modified Vaccinia Ankara (MVA)-based vaccine candidate or licensed vaccines, and Jynneos, Imvamune or Imvanex).
Recent or current use of any immunosuppressing medications in the 4 weeks prior to signing ICF.
**Topical, ophthalmic, inhaled, intranasal and intraarticular are acceptable, but receipt of >/= 20 mg/day of prednisone or equivalent for >/= 14 consecutive days in the 4 weeks prior to signing ICF is exclusionary.
Has known allergy or history of anaphylaxis or other serious adverse reaction to a vaccine or vaccine products.
***This includes individuals with history of severe allergic reaction to gentamicin, ciprofloxacin, chicken or egg protein.
Has any medical disease or condition that, in the opinion of the participating site Principal Investigator (PI) or appropriate sub-investigator, precludes study participation.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
0.1 mL of 2 x 10\^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29. N=70
Biological: JYNNEOS
0.05 mL of 1 x 10\^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29. N=70
Biological: JYNNEOS
0.5 mL of 1 x 10\^8 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered subcutaneously on Days 1 and 29. N=70
Biological: JYNNEOS
JYNNEOS is FDA-approved and licensed as a smallpox and monkeypox vaccine in the United States. JYNNEOS is a live vaccine produced from the strain Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), an attenuated, non-replicating orthopoxvirus. Each 0.5 mL dose is formulated to contain 0.5 x 10\^8 to 3.95 x 10\^8 infectious units of MVA-BN live virus in 10 mM Tris (tromethamine), 140 mM sodium chloride at pH 7.7. Subcutaneous is administered in the deltoid region, intradermal is administered in the volar aspect (inner side) of the forearm.
Vaccinia Virus Specific Plaque Reduction Neutralization Test (PRNT) Geometric Mean Titer (GMT) at Day 43
Venous blood was collected at Study Day 43 and the serum was analyzed via the PRNT assay to determine if GMT of the intradermal regimen of 2 x 10\^7 TCID50 MVA-BN and 1 x 10\^7 TCID50 MVA- BN were non-inferior to that of the licensed regimen of 1 x 10\^8 TCID50 MVA-BN administered subcutaneously.
Time frame: Day 43
Individual Peak GMT Through Day 365
Blood was collected at baseline and multiple timepoints post vaccination for evaluation in a vaccinia virus Western Reserve PRNT assay. For each participant, the highest assessment post vaccination was determined as their peak response. For each arm, the geometric mean of peak responses was determined.
Time frame: Day 1 through Day 365
Vaccinia Virus Specific PRNT GMT at Study Day 1, 15, 29, 43, 57, 90, 181, and 365
Blood was collected at baseline and multiple timepoints post vaccination for evaluation in a vaccinia virus Western Reserve PRNT assay. Geometric means were determined for each timepoint.
Time frame: Day 1 through Day 365
Vaccinia Virus Specific PRNT Half-life (t ½)
Half-life, defined as the time from expected peak response (Day 43) to 50% maximal response, was estimated using the first participant visit with titer results less than or equal to half the titer results at Day 43.
Time frame: Day 43 through Day 365
Number of Participants Reporting Solicited Systemic AEs Through 14 Days After Each Study Vaccination
Systemic AEs solicited on a memory aid provided to participants included fever, chills, nausea, headache, fatigue, change in appetite, myalgia, and arthralgia. Participants are considered reporting the systemic AE if they reported mild or greater severity at any time through 14 days after each study vaccination (Day 1 through Day 15 for Dose 1 and Day 29-43 for Dose 2).
Time frame: Day 1 through Day 43
Number of Participants Reporting Solicited Local AEs Through 14 Days After Each Study Vaccination
Local AEs solicited on a memory aid provided to participants included pain at injection site, erythema/redness, induration/swelling (functional grade based on interference with daily activity and any measure value greater than 2.5 cm) and pruritis at injection site. Participants are considered reporting the local AE if they reported mild or greater severity at any time through 14 days after each study vaccination (Day 1 through Day 15 for Dose 1 and Day 29 through 43 for Dose 2).
Time frame: Day 1 through Day 43
Number of Participants Reporting Unsolicited Related and Unrelated Adverse Events (AEs) Through 28 Days After Each Vaccination
Frequency of all unsolicited non-serious AEs from day of each study vaccination through 28 days after each vaccination (Day 1 through Day 29 for Dose 1 and Day 29 through Day 57 for Dose 2).
Time frame: Day 1 through Day 57
Number of Participants Reporting Related and Unrelated Medically Attended Adverse Events (MAAEs)
An MAAE is an unsolicited AE that results in unscheduled medical attention such as a hospitalization for less than 24 hours, an emergency room visit, or an otherwise unscheduled healthcare visit for any reason. All MAAEs were collected from Study Day 1 through Study Day 57, and all MAAEs deemed related to the vaccine were collected through Study Day 181.
Time frame: Day 1 through Day 181
Number of Participants Reporting Related and Unrelated Serious Adverse Events (SAEs)
SAEs included any untoward medical occurrence that resulted in death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. All SAEs were collected from Study Day 1 through Study Day 57, and all SAEs deemed related to the vaccine were collected through Study Day 181.
Time frame: Day 1 through Day 181
Number of Participants Who Withdrew or Discontinued Vaccination
Participants could voluntarily withdraw their consent for study participation for any reason at any time. Primary reason for withdrawal was recorded and early termination visits were attempted. Participants who received the first vaccination could choose to discontinue receipt of study vaccine for any reason and could choose to remain in the study (i.e., not withdraw from study). In addition, a participant could be discontinued from receipt of the second vaccination. Discontinuation from vaccination did not mean automatic withdrawal from the study, and participants were monitored for safety and immunogenicity if the participant consented.
Time frame: Day 1 through Day 365
Participants were healthy, non-pregnant, non-breastfeeding adults 18 to 50 years old recruited from the communities at large surrounding 8 clinical sites throughout the U.S. The enrollment period occurred between 09SEP2022 and 12OCT2022.
| Milestone | 2 x 10^7 ID MVA-BN | 1 x 10^7 ID MVA-BN | 1 x 10^8 SC MVA-BN |
|---|---|---|---|
| Started | 75 | 78 | 76 |
| Completed | 69 | 68 | 71 |
| Not completed | 6 | 10 | 5 |
| Withdrew: Lost to follow-up | 4 | 6 | 2 |
| Withdrew: Protocol violation | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 | 2 |
| Withdrew: Completion status unknown | 1 | 3 | 0 |
Venous blood was collected at Study Day 43 and the serum was analyzed via the PRNT assay to determine if GMT of the intradermal regimen of 2 x 10\^7 TCID50 MVA-BN and 1 x 10\^7 TCID50 MVA- BN were non-inferior to that of the licensed regimen of 1 x 10\^8 TCID50 MVA-BN administered subcutaneously.
| titer | 2 x 10^7 ID MVA-BN | 1 x 10^7 ID MVA-BN | 1 x 10^8 SC MVA-BN |
|---|---|---|---|
| Vaccinia Virus Specific Plaque Reduction Neutralization Test (PRNT) Geometric Mean Titer (GMT) at Day 43 | 203.2 (164.5 to 250.9) | 113.2 (90.3 to 141.9) | 288.9 (222.4 to 375.2) |
Blood was collected at baseline and multiple timepoints post vaccination for evaluation in a vaccinia virus Western Reserve PRNT assay. For each participant, the highest assessment post vaccination was determined as their peak response. For each arm, the geometric mean of peak responses was determined.
| Titer | 2 x 10^7 ID MVA-BN | 1 x 10^7 ID MVA-BN | 1 x 10^8 SC MVA-BN |
|---|---|---|---|
| Individual Peak GMT Through Day 365 | 215.8 (174.8 to 266.2) | 127.0 (100.1 to 161.1) | 312.0 (238.5 to 408.2) |
Blood was collected at baseline and multiple timepoints post vaccination for evaluation in a vaccinia virus Western Reserve PRNT assay. Geometric means were determined for each timepoint.
| Titer | 2 x 10^7 ID MVA-BN | 1 x 10^7 ID MVA-BN | 1 x 10^8 SC MVA-BN |
|---|---|---|---|
| Day 1 | 10.2 (9.8 to 10.5) | 10.4 (9.8 to 11.1) | 11.2 (9.8 to 12.8) |
| Day 15 | 38.6 (29.9 to 50.0) | 20.8 (16.8 to 25.8) | 39.7 (29.0 to 54.3) |
| Day 29 | 43.7 (33.8 to 56.4) | 24.4 (19.8 to 30.0) | 42.3 (31.0 to 57.6) |
| Day 43 | 203.2 (164.5 to 250.9) | 113.2 (90.3 to 141.9) | 288.9 (222.4 to 375.2) |
| Day 57 | 115.5 (92.2 to 144.7) | 75.6 (61.0 to 93.6) | 175.3 (135.1 to 227.5) |
| Day 90 | 60.2 (48.7 to 74.5) | 36.8 (29.3 to 46.1) | 91.3 (69.0 to 120.8) |
| Day 181 | 25.1 (20.4 to 30.9) | 17.3 (14.2 to 21.1) | 39.7 (28.8 to 54.6) |
| Day 365 | 25.4 (20.2 to 31.9) | 21.7 (16.6 to 28.4) | 41.2 (30.3 to 55.9) |
Half-life, defined as the time from expected peak response (Day 43) to 50% maximal response, was estimated using the first participant visit with titer results less than or equal to half the titer results at Day 43.
| days | 2 x 10^7 ID MVA-BN | 1 x 10^7 ID MVA-BN | 1 x 10^8 SC MVA-BN |
|---|---|---|---|
| Vaccinia Virus Specific PRNT Half-life (t ½) | 44 (11 to 326) | 43 (12 to 322) | 43 (9 to 352) |
Systemic AEs solicited on a memory aid provided to participants included fever, chills, nausea, headache, fatigue, change in appetite, myalgia, and arthralgia. Participants are considered reporting the systemic AE if they reported mild or greater severity at any time through 14 days after each study vaccination (Day 1 through Day 15 for Dose 1 and Day 29-43 for Dose 2).
| Participants | 2 x 10^7 ID MVA-BN | 1 x 10^7 ID MVA-BN | 1 x 10^8 SC MVA-BN |
|---|---|---|---|
| Number of Participants Reporting Solicited Systemic AEs Through 14 Days After Each Study Vaccination | 59 | 55 | 62 |
Local AEs solicited on a memory aid provided to participants included pain at injection site, erythema/redness, induration/swelling (functional grade based on interference with daily activity and any measure value greater than 2.5 cm) and pruritis at injection site. Participants are considered reporting the local AE if they reported mild or greater severity at any time through 14 days after each study vaccination (Day 1 through Day 15 for Dose 1 and Day 29 through 43 for Dose 2).
| Participants | 2 x 10^7 ID MVA-BN | 1 x 10^7 ID MVA-BN | 1 x 10^8 SC MVA-BN |
|---|---|---|---|
| Number of Participants Reporting Solicited Local AEs Through 14 Days After Each Study Vaccination | 73 | 75 | 70 |
Frequency of all unsolicited non-serious AEs from day of each study vaccination through 28 days after each vaccination (Day 1 through Day 29 for Dose 1 and Day 29 through Day 57 for Dose 2).
| Participants | 2 x 10^7 ID MVA-BN | 1 x 10^7 ID MVA-BN | 1 x 10^8 SC MVA-BN |
|---|---|---|---|
| Related AEs | 64 | 62 | 37 |
| Unrelated AEs | 31 | 26 | 18 |
An MAAE is an unsolicited AE that results in unscheduled medical attention such as a hospitalization for less than 24 hours, an emergency room visit, or an otherwise unscheduled healthcare visit for any reason. All MAAEs were collected from Study Day 1 through Study Day 57, and all MAAEs deemed related to the vaccine were collected through Study Day 181.
| Participants | 2 x 10^7 ID MVA-BN | 1 x 10^7 ID MVA-BN | 1 x 10^8 SC MVA-BN |
|---|---|---|---|
| Related MAAEs | 1 | 0 | 0 |
| Unrelated MAAEs | 11 | 9 | 4 |
SAEs included any untoward medical occurrence that resulted in death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. All SAEs were collected from Study Day 1 through Study Day 57, and all SAEs deemed related to the vaccine were collected through Study Day 181.
| Participants | 2 x 10^7 ID MVA-BN | 1 x 10^7 ID MVA-BN | 1 x 10^8 SC MVA-BN |
|---|---|---|---|
| Related SAEs | 0 | 0 | 0 |
| Unrelated SAEs | 0 | 1 | 1 |
Participants could voluntarily withdraw their consent for study participation for any reason at any time. Primary reason for withdrawal was recorded and early termination visits were attempted. Participants who received the first vaccination could choose to discontinue receipt of study vaccine for any reason and could choose to remain in the study (i.e., not withdraw from study). In addition, a participant could be discontinued from receipt of the second vaccination. Discontinuation from vaccination did not mean automatic withdrawal from the study, and participants were monitored for safety and immunogenicity if the participant consented.
| participants | 2 x 10^7 ID MVA-BN | 1 x 10^7 ID MVA-BN | 1 x 10^8 SC MVA-BN |
|---|---|---|---|
| Withdrew | 6 | 9 | 5 |
| Discontinued Vaccination | 1 | 1 | 0 |
Collected over Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 2 x 10^7 ID MVA-BN | 0/75 (0%) | 0/75 (0%) | 75/75 (100%) |
| 1 x 10^7 ID MVA-BN | 0/78 (0%) | 1/78 (1.3%) | 78/78 (100%) |
| 1 x 10^8 SC MVA-BN | 0/76 (0%) | 1/76 (1.3%) | 75/76 (98.7%) |
| Event | 2 x 10^7 ID MVA-BN | 1 x 10^7 ID MVA-BN | 1 x 10^8 SC MVA-BN |
|---|---|---|---|
| Euglycaemic diabetic ketoacidosisMetabolism and nutrition disorders | 0/75 | 0/78 | 1/76 |
| CystitisInfections and infestations | 0/75 | 1/78 | 0/76 |
| Event | 2 x 10^7 ID MVA-BN | 1 x 10^7 ID MVA-BN | 1 x 10^8 SC MVA-BN |
|---|---|---|---|
| Injection site indurationGeneral disorders | 68/75 | 75/78 | 50/76 |
| Injection site pruritusGeneral disorders | 64/75 | 73/78 | 42/76 |
| Injection site painGeneral disorders | 49/75 | 44/78 | 67/76 |
| Injection site erythemaGeneral disorders | 62/75 | 56/78 | 40/76 |
| Injection site discolourationGeneral disorders | 58/75 | 60/78 | 9/76 |
| FatigueGeneral disorders | 43/75 | 43/78 | 53/76 |
| Injection site noduleGeneral disorders | 51/75 | 46/78 | 34/76 |
| HeadacheNervous system disorders | 36/75 | 37/78 | 43/76 |
| Injection site indurationGeneral disorders | 37/75 | 33/78 | 40/76 |
| MyalgiaMusculoskeletal and connective tissue disorders | 24/75 | 19/78 | 33/76 |
| Age, Categorical(Participants) | 2 x 10^7 ID MVA-BN | 1 x 10^7 ID MVA-BN | 1 x 10^8 SC MVA-BN | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 75 | 78 | 76 | 229 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | 2 x 10^7 ID MVA-BN | 1 x 10^7 ID MVA-BN | 1 x 10^8 SC MVA-BN | Total |
|---|---|---|---|---|
| Mean | 32.2 ± 8.9 | 31.6 ± 8.9 | 32.7 ± 9.1 | 32.2 ± 8.9 |
| Sex/Gender, Customized(Participants) | 2 x 10^7 ID MVA-BN | 1 x 10^7 ID MVA-BN | 1 x 10^8 SC MVA-BN | Total |
|---|---|---|---|---|
| Cisgender Man | 40 | 36 | 36 | 112 |
| Cisgender Woman | 29 | 41 | 37 | 107 |
| Genderqueer | 1 | 0 | 0 | 1 |
| Gender Non-binary | 3 | 1 | 1 | 5 |
| Gender Non-conforming | 0 | 0 | 1 | 1 |
| Transgender Man/Trans Man | 1 | 0 | 0 | 1 |
| Transgender Woman/Trans Woman | 1 | 0 | 0 | 1 |
| Other | 0 | 0 | 0 | 0 |
| Decline to state | 0 | 0 | 1 | 1 |
| Sex: Female, Male(Participants) | 2 x 10^7 ID MVA-BN | 1 x 10^7 ID MVA-BN | 1 x 10^8 SC MVA-BN | Total |
|---|---|---|---|---|
| Female | 33 | 42 | 37 | 112 |
| Male | 42 | 36 | 39 | 117 |
| Ethnicity (NIH/OMB)(Participants) | 2 x 10^7 ID MVA-BN | 1 x 10^7 ID MVA-BN | 1 x 10^8 SC MVA-BN | Total |
|---|---|---|---|---|
| Hispanic or Latino | 10 | 15 | 22 | 47 |
| Not Hispanic or Latino | 65 | 63 | 54 | 182 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | 2 x 10^7 ID MVA-BN | 1 x 10^7 ID MVA-BN | 1 x 10^8 SC MVA-BN | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 1 | 1 |
| Asian | 11 | 9 | 7 | 27 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 11 | 13 | 14 | 38 |
| White | 50 | 51 | 47 | 148 |
| More than one race | 2 | 4 | 4 | 10 |
| Unknown or Not Reported | 1 | 1 | 3 | 5 |
| Region of Enrollment(participants) | 2 x 10^7 ID MVA-BN | 1 x 10^7 ID MVA-BN | 1 x 10^8 SC MVA-BN | Total |
|---|---|---|---|---|
| United States | 75 | 78 | 76 | 229 |
| HIV Status(Participants) | 2 x 10^7 ID MVA-BN | 1 x 10^7 ID MVA-BN | 1 x 10^8 SC MVA-BN | Total |
|---|---|---|---|---|
| HIV Negative | 73 | 75 | 73 | 221 |
| HIV Positive | 2 | 3 | 3 | 8 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Mar 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 drug tested here: MVA-BN smallpox vaccine
National Institute of Allergy and Infectious Diseases (NIAID) →