NCT06839989 (Mbote-HIVAX) is a Phase 2 clinical trial of Mpox vaccination with MVA-BN in Mpox (Monkeypox), sponsored by Institute of Tropical Medicine, Belgium.

Who is sponsoring NCT06839989?

NCT06839989 is sponsored by Institute of Tropical Medicine, Belgium.

What drugs are being tested in NCT06839989?

Interventions in NCT06839989: Mpox vaccination with MVA-BN.

What condition does NCT06839989 study?

NCT06839989 studies Mpox (Monkeypox).

Is NCT06839989 still recruiting?

NCT06839989 is currently recruiting now. Last updated 15 August 2025.

Last reviewed 2025-08-15 · How we verify

NCT06839989: Mbote-HIVAX

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

An Immunogenicity and Safety Trial of MVA-BN in Adults Living With HIV for the Prevention of Mpox Infection, in Kinshasa, DRC

Recruiting now Phase 2 Last updated 15 August 2025

What this trial tests

Phase 2 trial testing Mpox vaccination with MVA-BN in Mpox (Monkeypox) in 600 participants. Currently enrolling.

Timeline

4 August 2025

Primary endpoint
31 December 2025

31 December 2025

Quick facts

Lead sponsor	Institute of Tropical Medicine, Belgium
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	600
Start date	4 August 2025
Primary completion	31 December 2025
Estimated completion	31 December 2025
Sites	1 location across Democratic Republic of the Congo

Drugs / interventions tested

Mpox vaccination with MVA-BN — full drug profile →

Conditions studied

Mpox (Monkeypox) — all drugs for Mpox (Monkeypox) →

Sponsor

Institute of Tropical Medicine, Belgium

Who can join

Adults 18 to 45, any sex, with Mpox (Monkeypox). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open-label, phase 2, immunogenicity and safety trial of the MVA-BN vaccine for the prevention of mpox in adults living with HIV with different level of CD4 counts in Kinshasa, DRC. The study team aims to investigate whether the administration of 2 standard subcutaneous doses of the Modified Vaccinia Ankara of Bavarian Nordic (MVA-BN) vaccine given 28 days apart, is immunogenic and safe when administered to People Living with HIV (PLHIV) with different levels of CD4 counts in the Democratic Republic of the Congo (DRC). Enrollment will be stratified according to three different subgroups based on CD4 counts assessed during visit 1A: \<200 cells/µL; 200 to 499 cells/µL; ≥ 500 cells/µL. A total of 600 participants will be included in the trial, with 200 participants per subgroup. All participants will be invited to 6 trial visits over a period of 7 months. This study will take place in cooperation with the National Programme for the Fight against AIDS (PNLS), the 'Programme Elargi de Vaccination (PEV)' and the 'Institut National de Santé Publique (INSP)'. As part of the response to the current mpox epidemic in DRC, a large cohort of about 10,000 individuals living in Kinshasa will be vaccinated in this program. Vaccination will take place in the Centre Hospitalier Kabinda (CHK) and the Pakadjuma Health Centre. All people living with HIV (PLHIV) with the intention to be vaccinated in the CHK, will be asked for their willingness to participate in the MBOTE-HIVAX clinical trial until the sample size of 600 participants needed for this clinical trial is reached.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Mpox (Monkeypox)

Currently open trials in the same condition.

NCT07267390 — Investigating MPXV Viral Clearance in Mpox Cases and Secondary Attack Rate in Contacts · recruiting
NCT06353737 — Looking for Asymptomatic Mpox in a Population at High Risk · recruiting

Other Institute of Tropical Medicine, Belgium trials

Trials by the same sponsor.

NCT07463040 — Study Comparing Several Drugs to Understand Which Work Against Cutaneous Leishmaniasis (CL) · Phase 3 · not yet recruiting
NCT07174648 — Testing of a New Rapid Antigen Test for Plague in Ituri, Democratic Republic of the Congo. · not yet recruiting
NCT07499739 — Mpox Biology, Outcome, Transmission and Epidemiology - Tracking the Immune Response After mpoX vaCcination (MBOTE-TRAXX) · Phase 4 · not yet recruiting
NCT07342829 — Prospective Follow-up After MVA-BN Booster Vaccination · not yet recruiting
NCT06840860 — Epidemiological and Pathophysiological Insights Through a Cross-sectional Survey (EPIC) · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06839989 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Institute of Tropical Medicine, Belgium
Last refreshed: 15 August 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06839989.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing