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Trial to Evaluate the Immunogenicity of Dose Reduction Strategies of the MVA-BN Monkeypox Vaccine
NCT05512949 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- BIOLOGICAL JYNNEOS
Study Locations (8)
California
- University of California, San Diego (UCSD) - Antiviral Research Center (AVRC) — San Diego
District of Columbia
- George Washington University Medical Faculty Associates — Washington D.C.
Georgia
- The Hope Clinic of Emory University — Decatur
Maryland
- NIH Clinical Research Center, Investigational Drug Management and Research Section — Bethesda
Massachusetts
- Brigham and Women's Hospital — Boston
Missouri
- Saint Louis University Center for Vaccine Development — St Louis
Tennessee
- Vanderbilt University Medical Center — Nashville
Texas
- Baylor College of Medicine — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 229 participants |
| Start Date | 2022-09-09 |
| Est. Completion | 2025-02-24 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05512949
The ClinicalTrials.gov registry entry for NCT05512949 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 229 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Monkeypox appearing as the primary indexed condition, and to 1 intervention — of which JYNNEOS is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05512949 reports 8 study locations spanning 8 distinct geographic areas — top geographies include California, District of Columbia, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05512949 about?
NCT05512949 is a clinical study titled "Trial to Evaluate the Immunogenicity of Dose Reduction Strategies of the MVA-BN Monkeypox Vaccine". 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 ...
What is the current status of trial NCT05512949?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 229 participants. The study started on 2022-09-09. Estimated completion is 2025-02-24.
What conditions does trial NCT05512949 study?
This clinical trial studies the following conditions: Monkeypox. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05512949?
The interventions under investigation include: JYNNEOS (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05512949?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05512949 being conducted?
This trial has 8 study locations across California, District of Columbia, Georgia, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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