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Assessment of Safety Profile of MVA-BN Vaccine in the PALM-007 Study in DRC

NCT05734508 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2026-02-12

Study results available
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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.

Conditions

  • Monkeypox

Interventions

BIOLOGICAL

MVA-BN vaccine

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

Sponsors & Collaborators

  • Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-23
Primary Completion
2024-06-28
Completion
2024-06-28
FDA Drug
Yes

Countries

  • Democratic Republic of the Congo

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05734508 on ClinicalTrials.gov