A Phase 2 Randomized Multisite Trial to Inform Public Health Strategies Involving the Use of MVA-BN Vaccine for Mpox
Public ClinicalTrials.gov record NCT05740982. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2 Randomized, Open-Label, Multisite Trial to Inform Public Health Strategies Involving the Use of MVA-BN Vaccine for Mpox
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is a Phase 2 open-label, non-placebo controlled, multi-site clinical trial that will evaluate the standard SC regimen in adolescents ages 12 through 17 years, inclusive, and compared to the standard subcutaneous regimen in adults ages 18 to 50, inclusive. Approximately 135 healthy, vaccinia-naïve adults will be enrolled in a comparator arm (Arm 4) and will be given the standard, licensed regimen of 1x10\^8 TCID50 MVA-BN administered SC on Day 1 and 29. These adults (Arm 4) will be combined with the 76 healthy, vaccinia-naïve adults that received the standard SC regimen in Stage 1 (Arm 3). Together, this will be the comparator group for non-inferiority testing for the primary endpoint. Approximately 315 healthy, vaccinia-naïve adolescents will be enrolled and given 1x10\^8 TCID50 MVA-BN administered SC on Days 1 and 29 (Arm 5). The study will have a set target enrollment of at least 25% adolescents ages 12 to 14 years, inclusive, to ensure that adequate numbers of younger adolescents are enrolled. The primary objectives are 1.) to determine if peak (Day 43) humoral immune responses in adolescents ages 12 to 17 years following administration of a 2-dose 1 x 10\^8 TCID50 MVA-BN regimen administered SC are non-inferior to the response in adults ages 18 to 50 years who received the licensed 2-dose SC regimen of 1 x 10\^8 TCID50 MVA-BN ; and 2.) to describe safety of a 2-dose 1 x 10\^8 TCID50 MVA-BN regimen administered SC in adolescents ages 12 to 17 years.
Study identification
- NCT ID
- NCT05740982
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 450 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 12 Years to 50 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 21, 2023
- Primary completion
- Aug 27, 2024
- Completion
- Aug 27, 2024
- Last update posted
- Mar 26, 2026
2023 – 2024
United States locations
- U.S. sites
- 17
- U.S. states
- 13
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's of Alabama Child Health Research Unit (CHRU) | Birmingham | Alabama | 35233-0011 | — |
| George Washington University Medical Faculty Associates | Washington D.C. | District of Columbia | 20037 | — |
| Emory University School of Medicine | Atlanta | Georgia | 30322-1014 | — |
| University of Maryland, School of Medicine, Center for Vaccine Development and Global Health | Baltimore | Maryland | 21201-1509 | — |
| NIH Clinical Research Center, Investigational Drug Management and Research Section | Bethesda | Maryland | 20892-1504 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115-6110 | — |
| Saint Louis University Center for Vaccine Development | St Louis | Missouri | 63104-1015 | — |
| Washington University in St. Louis | St Louis | Missouri | 63110-1010 | — |
| University of Rochester Medical Center | Rochester | New York | 14642-0001 | — |
| Duke Vaccine and Trials Unit | Durham | North Carolina | 27703 | — |
| Cincinnati Children's Hospital Medical Center Vaccine Research Center | Cincinnati | Ohio | 45229-3039 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19146 | — |
| UPMC University Center | Pittsburgh | Pennsylvania | 15213 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | — |
| University of Texas Medical Branch | Galveston | Texas | 77555-0435 | — |
| Baylor College of Medicine | Houston | Texas | 77030-3411 | — |
| Kaiser Permanente Washington Health Research Institute | Seattle | Washington | 98101-1466 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05740982, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 26, 2026 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05740982 live on ClinicalTrials.gov.