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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
StatusActive, Not Recruiting
PhasePhase 4
Started
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Record History

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  1. Trial status changed: Recruiting → Active, Not Recruiting
    • Site details revised at 3 of 3 sites
    v4
  2. Site details revised at 2 of 3 sitesv3
  3. Primary endpoint(s) modifiedv2 Show 7 more changesShow less
    • Recruitment opened
    • Primary completion pushed from Nov 15, 2026 to Dec 15, 2026
    • Trial sites expanded: 0 → 3 locations
    • Study completion pushed from Nov 15, 2028 to Dec 15, 2028
    • Start date changed from estimate of Apr 15, 2026 to May 15, 2026
    • Eligibility criteria expanded, about 5 words
    • Study description expanded, about 4 words
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
(from sponsor)		 Mpox
Related terms Mpox, Monkeypox
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov