Phase 4
N=500
Assessment of Safety Profile of MVA-BN Vaccine in the PALM-007 Study in DRC
Monkeypox
Bottom Line
View on ClinicalTrials.gov: NCT05734508 ↗Enrolled (actual)
500
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Frequency of SAEs After First Dose of MVA-BN Vaccine — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- MVA-BN vaccine (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Jun 2024
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 | — |
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.
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). 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.