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)
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 1
Healthy Volunteers: t
View:
⁃ Individuals aged 12 months and above
⁃ Living in the study catchment area
⁃ Written informed consent/assent (if applicable)
⁃ Written informed consent
⁃ Individual who receives single dose of LC16m8 vaccine at one of the vaccination centers participating in the study.
⁃ Must be reachable by phone (must have an active phone number of his/her own or in the household) throughout study participation.
• Patients (with any vaccination status) presenting to a sentinel surveillance health facility with clinical signs and symptoms consistent with mpox disease (probable or suspected)
• Reside in the study area prior to testing.
• Eligible to receive LC16m8 vaccine during the vaccination.
• Give consent/assent (if applicable) to participate in the study.
Locations
Other Locations
Democratic Republic of the Congo
The Institut National de la Recherche Biomédicale (INRB)
RECRUITING
Kinshasa
Contact Information
Primary
Birkneh Tilahun Tadesse, MD
birkneh.tadesse@ivi.int
+821098041348
Backup
Meseret Behute, MD
Meseret.Behute@ivi.int
+82129732401
Time Frame
Start Date:2025-12-03
Estimated Completion Date:2027-12-31
Participants
Target number of participants:11990
Treatments
Cohort Event Monitoring (CEM) - Safety cohort
At enrollment/vaccination visit, participants will be consecutively invited to be enrolled in the safety subset until the sample size of 10,000 has been achieved. The enrollment aims to include a proportional number of participants from various age groups, including 1-5 years, 6-12 years and 13-18 years, with representation from both sexes. The participation will be strictly voluntary according to the eligibility criteria.~Enrolled vaccinees will be actively followed up through phone calls/home visits/Health facility visits for the SAEs and AESIs assessment at weekly intervals for the first month and then at monthly intervals until 12 weeks post vaccination. Vaccinees/parents/guardians will be advised to return to the sentinel health facility if any serious event occurs at any time.
Vaccine Effectiveness (VE) Assessment
Health facility-based enhanced mpox surveillance will be implemented to record mpox cases within the vaccination catchment area. The study will be done in 2 or more health zones identified as hot spots by the DRC government. All patients presenting with probable or suspected mpox to the surveillance healthcare facilities will be approached for testing and enrollment into the surveillance study.~Vaccine effectiveness will be estimated using cases and controls assembled based on specific inclusion/exclusion criteria. A total of 1,990 participants (398 cases and 1,592 controls) will be required for assessment of vaccine effectiveness.