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Evaluation of Effectiveness and Safety of LC16m8 Mpox Vaccine in the Democratic Republic of Congo (DRC)

Study acronym: MPX-001
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Recruitment opened
    • Start date changed from estimate of Sep 30, 2025 to Dec 3, 2025
    • Site details revised
    • Study description shortened, about 1 word
    v3
  2. Start date: Aug 1, 2025 to Sep 30, 2025
    • Secondary endpoints: details revised at 1 of 5 entries
    • Collaborators reordered
    • Study description expanded, about 5 words
    v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a health facility-based prospective test-negative (TND) case-control study to evaluate vaccine effectiveness and active safety monitoring (cohort event monitoring), and passive surveillance for evaluation of the safety of the LC16m8 mpox vaccine in individuals aged one year and older in the DRC. This study aims to assess the LC16m8 vaccine effectiveness and safety. The following activities will be carried out: * Community engagement * Enhanced health facility-based mpox disease surveillance * Vaccination using the LC16m8 vaccine * Safety monitoring following immunization * LC16m8 Vaccine effectiveness evaluation using a TND Study Hypothesis: The LC16m8 vaccine, administered as pre-exposure prophylaxis, confers greater than 70% protection against symptomatic mpox disease among adults and children in the DRC.
Trial Details
NCT Number NCT07093489
Lead Sponsor International Vaccine Institute
Collaborators: Japan Institute for Health Secutiry, Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
Conditions
(from sponsor)		 Mpox (Monkeypox), Mpox
Related terms Mpox, Monkeypox
Enrollment 11,990 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov