Massive mpox vaccine trial launches in DRC: could it stop the outbreak?

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

1. Vaccination: Inclusion criteria * Individuals aged 12 months and above * Living in the study catchment area * Written informed consent/assent (if applicable) Exclusion criteria * 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) * Individuals with known underlying uncontrolled chronic diseases such as diabetes mellitus, cardiovascular disease, renal disease, hepatic disease, hematological disease, and developmental disturbance * Individuals with a history of hypersensitivity caused by a component of the vaccine Temporary exclusion criteria * Individuals with objective fever (Frontal temperature ≥ 38.5°C) or axillary temperature \> 37.5 °C * Individuals suffering from acute illness within 48 hours prior to vaccination and based on investigator judgement. * Receipt of any live vaccine injection within the previous 27 days (measles vaccine, rubella vaccine, mumps vaccine, varicella vaccine, BCG vaccine, yellow fever vaccine...). 2. Cohort Event Monitoring (CEM): Inclusion criteria * 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. Exclusion criteria • Individual/parent/guardian unable to comply with the study procedures 3. Mpox surveillance (VE): General Inclusion Criteria: * 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. Exclusion Criteria * Individuals meeting any of the following criteria are not eligible for testing and enrollment in the study: * Known contraindications for LC16m8 vaccine. * As per the Investigator's medical judgement, an individual could be excluded from the study despite meeting all the inclusion/exclusion criteria mentioned above.