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Monkeypox vaccine safety under the microscope in congo study

NCT ID NCT05734508

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

500 people

The number who actually took part.

Started

Mar 2023

Finished

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

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • L'Hôpital Général de Référence de Kole

    Kole, Democratic Republic of the Congo

  • L'Hôpital Général de Référence de Tunda

    Tunda, Democratic Republic of the Congo

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