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NCT05740982 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Randomized Multisite Trial to Inform Public Health Strategies Involving the Use of MVA-BN Vaccine for Mpox
A Phase 2 study of Monkeypox, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 450
- Enrollment target
- 18
- Study locations
NCT05740982 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 450 participants, above the 142-participant average among 3 other Monkeypox trials with a reported enrollment target (217% higher). The trial reports 18 study locations across 14 states.
The verdict
NCT05740982, 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
- 450 participants
- Enrollment target
- 18
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- BIOLOGICAL JYNNEOS
Study Locations (18)
Maryland
- University of Maryland, School of Medicine, Center for Vaccine Development and Global Health - Baltimore
- NIH Clinical Research Center, Investigational Drug Management and Research Section - Bethesda
Missouri
- Saint Louis University Center for Vaccine Development - St Louis
- Washington University in St. Louis - St Louis
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
- UPMC University Center - Pittsburgh
Texas
- University of Texas Medical Branch - Galveston
- Baylor College of Medicine - Houston
Alabama
- Children's of Alabama Child Health Research Unit (CHRU) - Birmingham
District of Columbia
- George Washington University Medical Faculty Associates - Washington D.C.
Georgia
- Emory University School of Medicine - Atlanta
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2023-03-22 |
| Est. Completion | 2024-08-28 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05740982
The ClinicalTrials.gov registry entry for NCT05740982 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 142-participant average among 3 other Monkeypox trials with a reported enrollment target (217% higher). 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.
NCT05740982 reports 18 study locations spanning 14 distinct geographic areas - top geographies include Maryland, Missouri, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05740982 about?
NCT05740982 is a clinical study titled "A Phase 2 Randomized Multisite Trial to Inform Public Health Strategies Involving the Use of MVA-BN Vaccine for Mpox". 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, vaccin...
What is the current status of trial NCT05740982?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 450 participants. The study started on 2023-03-22. Estimated completion is 2024-08-28.
What conditions does trial NCT05740982 study?
This clinical trial studies the following conditions: Monkeypox.
What interventions are being tested in trial NCT05740982?
The interventions under investigation include: JYNNEOS (BIOLOGICAL).
Who is sponsoring clinical trial NCT05740982?
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 NCT05740982 being conducted?
This trial has 18 study locations across Alabama, District of Columbia, Georgia, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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