Evaluation of Effectiveness and Safety of LC16m8 Mpox Vaccine in the Democratic Republic of Congo (DRC)
Evaluation of the Effectiveness and Safety of the LC16m8 Mpox Vaccine in Individuals Aged One Year and Older in the Democratic Republic of Congo (DRC)
International Vaccine Institute
11,990 participants
Dec 3, 2025
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
LC16m8 vaccine will be offered to all individuals aged \>1 year and meet the inclusion criteria within the catchment population. This will be done in line with the DRC government's LC16m8 vaccine roll out plan.
Locations(1)
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NCT07093489