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

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.

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	Mpox (Monkeypox), Mpox
Enrollment	11,990 participants
Start Date	2025-09-30
Primary Completion	2027-08-01 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-09-15