MVA-BN monkeypox vaccine safety in a clinical trial in the Democratic Republic of the Congo
npj Vaccines·
- DOI
- 10.1038/s41541-026-01490-0
- PMID
- 42209512
- PMCID
- —
- OpenAlex
- W7162683994
- Study type
- Journal article
- Publisher
- Springer Science and Business Media LLC
- Article type
- journal-article
- Integrity
- current
Why this research matters now
The findings provide additional evidence from an endemic setting that the MVA-BN vaccine, widely deployed for monkeypox prevention, is generally safe and well-tolerated with predominantly mild injection site reactions.
Structured evidence summary
Research question
The study evaluated the safety and tolerability of the MVA-BN monkeypox vaccine among adults working in a high-risk, endemic setting in the Democratic Republic of the Congo.
Study design
This was a single-arm clinical trial with active follow-up for 28 days after each of two vaccine doses administered 28 days apart. Participants were enrolled from March 2023 to June 2024.
Population and setting
The study enrolled 500 adults working as personnel on a monkeypox therapeutics trial in an endemic, high-risk setting in the Democratic Republic of the Congo. Of these, 494 participants received both vaccine doses and completed follow-up.
Main findings
No adverse events of grade 3 or higher were observed. Approximately one-third of participants reported at least one vaccination site reaction, most commonly mild or moderate injection site pain occurring in 24% after the first dose and 10% after the second dose. One case of breakthrough monkeypox infection occurred approximately three months following the second dose.
Public-health relevance
The findings provide additional evidence from an endemic setting that the MVA-BN vaccine, widely deployed for monkeypox prevention, is generally safe and well-tolerated with predominantly mild injection site reactions.
Important limitations
This summary relies on the supplied single-article abstract and metadata. The abstract does not specify exclusion criteria, baseline participant health characteristics, or duration of follow-up beyond 28 days post-dose for most safety outcomes. Decision-grade interpretation requires review of the full published article.
GIDS interpretation
This peer-reviewed journal article in npj Vaccines addresses monkeypox vaccine safety in the Democratic Republic of the Congo and was classified under vaccination and vaccine safety topics. The study contributes safety data from an endemic African setting where such evidence has been limited.
Related GIDS surveillance
Literature context does not validate, explain, or change a surveillance signal. Exact and contextual relationships are shown separately.
Evidence relationships
This article has 11 auditable classifier relationships to diseases, places, topics, and study design.