💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
HealthTeky