CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 500 enrolled
Drug / intervention
MVA-BN vaccinebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05734508
NCT05734508Phase 4Completed
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Cohort Events Monitoring (CEM) Study for the Assessment of Safety Profile of MVA-BN (Jynneos) Vaccine in Adult Personnel and Staff in the PALM-007 Study in Democratic Republic Of The Congo

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Feb 21, 2023·Updated Feb 12, 2026

In Brief

A Phase 4 clinical trial evaluating MVA-BN vaccine for Monkeypox. Completed, enrolled 500 participants across 3 sites.

Detailed Summary

The goal of this observational study is to monitor and assess the safety profile of the MVA-BN vaccine among staff and study personnel of the PALM-007 study in the Democratic Republic of the Congo. The main questions it aims to answer are: * To estimate the incidence of serious adverse events (SAEs) in all individuals vaccinated with the MVA-BN vaccine * To estimate the incidence of adverse events (AEs) after each dose of MVA-BN vaccine. Participants will receive two doses of vaccine and will be actively followed up to the 28th day after their last dose of MVA-BN vaccine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMonkeypox
CountriesDemocratic Republic of the Congo
CollaboratorsInstitut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo

Timeline

Phase 4CompletedFinished
202420252026
First PostedFeb 21, 2023
Enrollment StartMar 23, 2023
Primary CompletionJun 28, 2024
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 3.4 years ago

Interventions

MVA-BN vaccinebiological

A live vaccine produced from the Modified Vaccinia Ankara-Bavarian Nordic strain (MVA-BN), an attenuated and non-replicating orthopox virus