Clinical Trial

Mpox Biology, Outcome, Transmission and Epidemiology - Tracking the Immune Response After mpoX vaCcination (MBOTE-TRAXX): Clinical Study to Monitor the Immunological Response Following Mpox Vaccination in the City of Kinshasa, Democratic Republic of the Congo

Study acronym: MBOTE-TRAXX
Active, Not Recruiting Phase 4
View on ClinicalTrials.gov →
Summary
The study Mbote-TRAXX evaluates humoral and cellular immune responses in individuals vaccinated against mpox with the MVA-BN or LC16m8 vaccine administered as part of a routine mpox vaccination campaign in Kinshasa, Democratic Republic of the Congo (DRC). Participants will be followed up at multiple time points after vaccination in order to assess the kinetics and durability of the immune response by collection of blood samples. It is planned to include approximately 150 participants vaccinated with MVA-BN and 150 participants vaccinated with LC16m8.
Protocol Amendment History 6 changes
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-06-12
critical Recruitment opened 2026-05-20
critical Primary endpoint(s) modified 2026-05-20
notable Trial sites expanded: 0 -> 3 locations 2026-05-20
notable Primary completion pushed: 2026-11-15 -> 2026-12-15 2026-05-20
minor Completion pushed: 2028-11-15 -> 2028-12-15 2026-05-20
Trial Details
NCT Number NCT07499739
Lead Sponsor Institute of Tropical Medicine, Belgium
Collaborators: Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo, Programme Elargi de Vaccination de République Démocratique du Congo, National Institute of Public Health of the Democratic Republic of the Congo
Conditions Mpox
Enrollment 300 participants
Start Date 2026-05-15
Primary Completion 2026-12-15 (estimated)
Study Completion 2028-12-15 (estimated)
Updated on ClinicalTrials.gov 2026-06-11