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Mpox vaccine trial targets HIV-Positive adults in DRC

NCT ID NCT06839989

Prevention Sponsor: Institute of Tropical Medicine, Belgium Source: ClinicalTrials.gov ↗

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether the MVA-BN mpox vaccine is safe and triggers a strong immune response in 600 adults living with HIV in Kinshasa, DRC. Participants receive two vaccine doses 28 days apart and are grouped by their CD4 count. The goal is to see if the vaccine works well for people with different levels of immune health.

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 vaccine (Modified Vaccinia Ankara - Bavarian Nordic)
What this could lead to
If successful, this could show that the MVA-BN vaccine is safe and effective for preventing mpox in people living with HIV, potentially leading to better protection for this vulnerable group.
What could go wrong
This is a mid-stage trial focused on immune response and safety, not on preventing actual mpox infection. Results may not apply to people with very low CD4 counts or outside the DRC.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Age ≥ 18 years and ≤ 45 years at time of informed consent * Able and willing to provide written informed consent * Infected with HIV and receiving combination antiretroviral therapy (ART) for ≥ 8 weeks prior to study entry and vaccination * Preparedness to follow the study schedule * Willingness to use contraception for 1 month after each vaccination (only for women of childbearing potential) Exclusion Criteria: * A known history of mpox and/or smallpox * A known history of vaccination with 1st, 2nd or 3rd generation smallpox vaccines, or vaccine platforms that contain MVA as a vector * Planned MVA-based vaccination (other than study vaccination) during the trial * Close contact to a confirmed mpox case in the 3 weeks prior to study enrollment * Uncontrolled severe infection or other condition requiring hospitalization * Pregnancy * History of anaphylaxis or severe allergic reaction to any vaccine or known allergy to one of the components of the study vaccine

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Conditions

The condition(s) this trial relates to.

HIV infectious disease monkeypox prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mpox (monkeypox)

Contacts and locations

Locations

  • Centre Hospitalier Kabinda

    Kinshasa, Democratic Republic of the Congo

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