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

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.

Timeline

Start

2023-03-23

Primary completion

2024-06-28

Completion

2024-06-28

Publications

• Ntamabyaliro N, Bonnett T, Potter G, Yox E, Liesenborghs L, Mbaya OT, Nussenblatt V, Kilara TK, Engo AB, Muhima E, Velela P, Itunime L, Biampata JL, Mbala P, Lusakibanza M, Basika MK, Tona G, Vogel S, Lane HC, Dodd LE, Muyembe JJ. MVA-BN monkeypox vaccine safety in a clinical trial in the Democratic Republic of the Congo. NPJ Vaccines. 2026 May 28. doi: 10.1038/s41541-026-01490-0. Online ahead of print.

Drugs

Indications