CompletedPhase 4

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

Democratic Republic of the Congo500 participantsStarted 2023-03-23

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Frequency of SAEs After First Dose of MVA-BN Vaccine

Timeframe: Within 14 days of first vaccine dose

Frequency of SAEs After Second Dose of MVA-BN Vaccine

Timeframe: Within 14 days of second vaccine dose

Frequency of AEs After First Dose of MVA-BN Vaccine

Timeframe: Within 14 days of first vaccine dose

Frequency of AEs After Second MVA-BN Vaccine Dose

Timeframe: Within 28 days of second vaccine dose

Trial details

NCT IDNCT05734508

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2024-06-28

Results submitted2026-01-05

View on ClinicalTrials.gov More Monkeypox trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Frequency of SAEs After First Dose of MVA-BN Vaccine

Timeframe: Within 14 days of first vaccine dose

Frequency of SAEs After Second Dose of MVA-BN Vaccine

Timeframe: Within 14 days of second vaccine dose

Frequency of AEs After First Dose of MVA-BN Vaccine

Timeframe: Within 14 days of first vaccine dose

Frequency of AEs After Second MVA-BN Vaccine Dose

Timeframe: Within 28 days of second vaccine dose