Monkeypox vaccine safety under the microscope in congo study
NCT ID NCT05734508
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed study monitored the safety of the MVA-BN (Jynneos) vaccine in 500 adults at high risk for monkeypox in the Democratic Republic of the Congo. Participants received two doses of the vaccine and were followed for up to 28 days after their last dose. The main goal was to track any serious or minor side effects that occurred shortly after vaccination.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MVA-BN (Jynneos) vaccine
- What this could lead to
- If the vaccine is shown to be safe, it could support its use to protect people at high risk for monkeypox.
- What could go wrong
- This study only looked at safety, not how well the vaccine prevents infection. It was also small and limited to a specific group of adults.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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500 people
The number who actually took part.
- Started
-
Mar 2023
- Finished
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Jun 2024
- Lead sponsor
-
A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Institut National de Rescherche Biomédicale (INRB)
Kinshasa, Democratic Republic of the Congo
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L'Hôpital Général de Référence de Kole
Kole, Democratic Republic of the Congo
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L'Hôpital Général de Référence de Tunda
Tunda, Democratic Republic of the Congo
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can we better understand mpox in young people?
- Can a smallpox vaccine stop mpox in its tracks?
- Experimental drug targets smallpox and monkeypox after exposure
- Monkeypox vaccine immune response under the microscope
- Can a pill speed up monkeypox recovery? major trial underway
- Scientists investigate mpox in severely weakened immune systems