Evaluation of Effectiveness and Safety of LC16m8 Mpox Vaccine in the Democratic Republic of Congo (DRC)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1+
SponsorInternational Vaccine Institute
About this trial
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 criteria
Qualifiers
Individuals aged 12 months and above
Living in the study catchment area
Written informed consent/assent (if applicable)
Disqualifiers
Prior receipt of any mpox vaccine dose
Women known to be pregnant or breast feeding
Individuals suffering from any spreading skin disease
Immunocompromised individuals with known severe immuno-deficiency conditions (example, HIVAIDS, individuals being on chronic use of systemic steroids (>2 mg/kg/day or >20 mg/day prednisolone equivalent for periods exceeding 10 days, cytotoxic or other immunosuppressive drugs)
Trial design
Treatments tested in this trial
- LC16m8
Treatment groups
11,990 Participants
are divided into 2 treatment groupsSponsors and collaborators
International Vaccine Institute
Lead sponsor
Japan Institute for Health Secutiry
Collaborator
Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
Collaborator
Source ClinicalTrials.gov