MVA-BN vaccine to prevent mpox in adults living with HIV in Kinshasa
The Mpox Biology, Outcome, Transmission and Epidemiology Project - HIV Immunization and Vaccination Against Mpox eXposure Trial
This trial will test whether two standard doses of the MVA-BN vaccine given 28 days apart are safe and produce strong immune responses in adults living with HIV in Kinshasa.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Institute of Tropical Medicine, Belgium Academic / other |
| Locations | 1 site (Kinshasa) |
| Trial ID | NCT06839989 on ClinicalTrials.gov |
What this trial studies
This is an open-label phase 2 trial enrolling 600 adults living with HIV in Kinshasa who are on antiretroviral therapy. Participants are stratified into three groups by CD4 count (<200, 200–499, ≥500 cells/µL) with 200 people per group and will receive two subcutaneous MVA-BN doses 28 days apart. Safety and immune responses will be measured across six visits over about seven months. The study excludes people with prior smallpox/mpox vaccination, recent mpox exposure, pregnancy, or severe uncontrolled infections.
Who should consider this trial
Good fit: Adults aged 18–45 living with HIV who have been on combination ART for at least 8 weeks, without prior smallpox/mpox vaccination or recent mpox exposure, and willing to follow the visit schedule and contraception requirements if applicable.
Not a fit: People who are pregnant, have a history of smallpox/mpox vaccination or recent close contact with a confirmed mpox case, or who have uncontrolled severe infections are unlikely to benefit or will be excluded.
Why it matters
Potential benefit: If successful, the vaccine could offer a safe and effective way to prevent mpox in adults living with HIV across a range of immune statuses.
How similar studies have performed: MVA-BN (Jynneos/Imvamune/Imvanex) has been used widely and shown immunogenicity and an acceptable safety profile, though data specifically across low CD4 subgroups remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Kinshasa
- Centre Hospitalier Kabinda — Kinshasa, Democratic Republic of the Congo (Recruiting)
Study contacts
- Principal investigator: Laurens Liesenborghs, MD — Institute of Tropical Medicine
- Study coordinator: Stefanie Bracke, MD
- Email: sbracke@itg.be
- Phone: +32 3 3455580
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.