Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05512949 · ClinicalTrials.gov registry record · Phase 2
Trial to Evaluate the Immunogenicity of Dose Reduction Strategies of the MVA-BN Monkeypox Vaccine
A Phase 2 study of Monkeypox, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 229
- Enrollment target
- 8
- Study locations
NCT05512949 is a Phase 2 study of Monkeypox that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 229 participants, roughly in line with the 215-participant average among 3 other Monkeypox trials with a reported enrollment target. The trial reports 8 study locations across 8 states.
The verdict
NCT05512949, a Phase 2 study of Monkeypox, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 229 participants
- Enrollment target
- 8
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 229 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 215-participant average among 3 other Monkeypox trials with a reported enrollment target. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
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.
NCT05512949 reports 8 study locations spanning 8 distinct geographic areas - top geographies include California, District of Columbia, Georgia.
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.
What interventions are being tested in trial NCT05512949?
The interventions under investigation include: JYNNEOS (BIOLOGICAL).
Who is sponsoring clinical trial NCT05512949?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Monkeypox
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Phase 2 Randomized Multisite Trial to Inform Public Health Strategies Involving the Use of MVA-BN Vaccine for Mpox
COMPLETED · Phase 2
-
Virologic and Immunologic Characteristics of Severe Mpox in Persons With Advanced HIV
RECRUITING
-
A Clinical Study Investigating the Safety and Immune Responses After Immunization With Investigational Monkeypox Vaccines
ACTIVE NOT RECRUITING · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.