Phase 4
Completed N=500
Assessment of Safety Profile of MVA-BN Vaccine in the PALM-007 Study in DRC
Source: ClinicalTrials.gov NCT05734508 ↗Enrolled (actual)
500
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcomePrimary: Frequency of SAEs After First Dose of MVA-BN Vaccine — 0 Participants
◆ Published Evidence
Not yet cited
0citations
MVA-BN monkeypox vaccine safety in a clinical trial in the Democratic Republic of the Congo.
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.
Linked Publications
-
MVA-BN monkeypox vaccine safety in a clinical trial in the Democratic Republic of the Congo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of SAEs After First Dose of MVA-BN Vaccine |
— | — |
| PRIMARY Frequency of SAEs After Second Dose of MVA-BN Vaccine |
— | — |
| PRIMARY Frequency of AEs After First Dose of MVA-BN Vaccine |
219 | — |
| PRIMARY Frequency of AEs After Second MVA-BN Vaccine Dose |
102 | — |
Eligibility Criteria
Inclusion Criteria
- Provides written informed consent
- 18 years of age or older
- At high risk for Monkeypox infections
- Personnel and staff associated with the PALM 007-Monkeypox study sites in the DRC
- Willingness and ability to communicate AEs to study personnel
Exclusion Criteria
- Allergy to MVA-BN or any of its components
- Pregnant or breastfeeding women
- Fever (axillary temperature ≥37.5°celsius)
- People who have already received the MVA-BN vaccine (in routine vaccination or another study involving this vaccine)
- Participants who, in the judgement of the investigator, will be at significantly increased risk as a result of participation in the study
- Individuals with any condition or circumstance that would render them unable to comply with study procedures (e.g., not reachable by phone)
Data sourced from ClinicalTrials.gov (NCT05734508) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.