Monkeypox
Conditions
Interventions
LC16m8 Vaccine
None
Sponsors
Institut National de la Recherche Biomedicale
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Vaccination: - Individuals aged 12 months and above - Living in the study catchment area 2. Cohort Event Monitoring (CEM): - 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. 3. Mpox surveillance (VE): - 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
Exclusion criteria: 1. Vaccination: - 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 immunodeficiency 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 1.1 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): - Individual/parent/guardian unable to comply with the study procedures 3. Mpox surveillance (VE): - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with complete mpox vaccination among those with symptomatic, RT-PCR confirmed mpox infection compared to those who test negative for mpox RT-PCR. This outcome measures the percentage of participants who had complete vaccination among those who tested positive for mpox by RT-PCR in comparison to the percentage of participants who had complete vaccination who tested negative for mpox by RT-PCR. Unit of Measure: Odds ratio Measurement tool: The odds of complete Vaccination status determined through vaccination record or participant self-report (complete vaccination is defined as symptom onset =14 days after receiving mpox vaccine) among mpox positive cases (RT-PCR positive) compared to the odds of complete Vaccination status among controls (mpox RT-PCR negative). | — |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of participants with complete vaccination in different age strata of participants with RT-PCR-confirmed mpox disease compared with the percentage of participants with complete vaccination in those without mpox disease. This outcome will assess the correlation between mpox disease status and vaccination status at the time of enrollment. Specifically, the investigators will compare the odds of having received a complete mpox vaccination among participants with RT-PCR-confirmed mpox disease to the odds among those who test negative for mpox. Analyses will be stratified by age group to explore potential age-related differences in vaccine coverage and effectiveness. Complete vaccination is defined as onset of first mpox symptoms 14 days or more after receipt of mpox vaccine. Unit of measure: Odds ratio Measurement tool: The odds of complete vaccination status (complete vaccination is defined as symptom onset =14 days after receiving mpox vaccine) in among mpox positive cases (RT-PCR positive) compared to the odds of complete Vaccination status among controls (mpox RT-PCR negative).;The percentage of participants with incomplete vaccination among participants with RT-PCR-confirmed mpox disease compared to the percentage of participants with incomplete vaccination among participants with negative mpox RTPCR (overall & stratified by age). This outcome measures the odds of having an incomplete mpox vaccination status among participants with RT-PCR confirmed mpox at the time of enrollment compared to participants who test negative to mpox. Incomplete vaccination is defined as onset of first mpox symptoms within 14 days of receipt of mpox vaccine. The analysis will be conducted both overall and stratified by age to examine potential differences across age groups. Unit of measurement: Odds ratio Measurement tool: The odds of incomplete vaccination status (incomplete vaccination is defined as symptom onset within 14 days of receiving mpox vaccine) amon | — |
Countries
Democratic Republic of the Congo
Contacts
Public ContactFlorian;Pierre Marks;Mutantu
International Vaccine Institute;Institut National de Recherche Biomedicale
Outcome results
None listed