A One Health Study of Monkeypox Human Infection

Study Overview
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Brief Summary
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This multidisciplinary project aim to understand the epidemiology of the monkeypox in Central African Republic through the identification of the animal reservoir, the clinical and epidemiological description of the human outbreak, through an ethnological approach around risk factors of the disease and through an ecological approach of the ecological context of emergence, and the improvement of biological diagnosis.

Detailed Description
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This project is composed by monkyepox disease outbreak investigation in the CAR following national surveillance framework.

Official Title
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A One Health Study of Monkeypox Human Infection, Animal Reservoir, Disease Ecology and Diagnostic Tools

Conditions
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Monkeypox Virus Infection

Intervention / Treatment
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* Other: blood samples
* Other: Scabs and pus samples


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Human population in villages affected by monkeypox epidemics: patients who developed monkeypox and their contacts Health care personnel (paramedics, nurses, doctors) who work or have worked in affected villages Traditional healers, diviners Members of villages affected by past monkeypox epidemics Exclusion Criteria: area not accessible to investigation refusal to participate inability to obtain consent
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Risk factors transmission cases<br>Human cases of monkeypox confirmed by PCR | Other: blood samples<br>* 5 mL<br>Other: Scabs and pus samples<br>* if available<br>|
| Risk factors transmission contacts and co-exposures<br>Human contact of confirmed monkeypox cases | Other: blood samples<br>* 5 mL<br>|
| Serological follow up cases<br>Human cases of monkeypox confirmed by PCR from Lobaye region | Other: blood samples<br>* 5 mL<br>Other: Scabs and pus samples<br>* if available<br>|
| Serological follow up contacts and co-exposures<br>Human contact of confirmed monkeypox cases from Lobaye region adjusted for age, month of the year and village of origin | Other: blood samples<br>* 5 mL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of monkeypox cases occuring following interhuman exposures | through a quantitative case-control study with an odds ratio of >3 for an exposure factor for human-to-human transmission. | 36 months | 
| Proportion of monkeypox cases occuring following zoonotic exposures | through a quantitative case-control study with an odds ratio of >3 for an exposure factor for zoonotic transmission. | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the Effective reproduction rate R in CAR according to the level of immunity (smallpox vaccine immunity or orthopoxvirus-related post disease immunity). | measurement of the level of population natural immunity and post vaccinal immunity to determine the Effective reproduction rate R and changes in R between 2000-2020 according to the evolution of immunity (smallpox vaccine immunity or orthopoxvirus-related post disease immunity). | 36 months | 
| measurement of the sensitivity and the specificity of the existing diagnostic tests and those developed within the framework of the project | sensitivity and specificity of the existing diagnostic tests and those developed within the framework of the project, as well as the reproducibility of measurements in relation to reference tests. | 36 months | 
| Identification and interpretation of genomic viral mutations from the viral sequences isolated from humans and animals in CAR for Phylogenetic and phylogeographic study of the monkeypox virus | identification and interpretation of mutations, search for the common ancestor. | 36 months | 
| Comparison of genetic proximities between different viral strains isolated in humans and animals in CAR and neighboring countries since 1980. | Comparison of genetic proximities | 36 months | 
| Identification of the characteristics associated with the environments in which human cases of monkeypox virus infection have occurred | ecosystems and their recent modifications, land use, associated climatic/meteorological elements in the tropical zone (CAR, Northern DRC...). | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epidemiology, outbreak investigation, anthropology,, animal reservoir, zoonotic disease, field diagnosis