Clinical trial NCT05058898: A One Health Study of Monkeypox Human Infection
Official title: A One Health Study of Monkeypox Human Infection, Animal Reservoir, Disease Ecology and Diagnostic Tools
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Monkeypox Virus Infection
Keywords: epidemiology
outbreak investigation
anthropology,
animal reservoir
zoonotic disease
field diagnosis
Lead sponsor: Institut Pasteur
Sponsor class: INDUSTRY
Collaborators: name: Institut Pasteur de Bangui
First posted: 2021-09-28
Enrollment: 280
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The populations concerned by the study correspond to the sedentary populations known as "Bantus" and the more mobile populations known as "pygmies. These populations belong to different ethno-linguistic groups with more or less specific forest uses and subsistence practices: some are slash-and-burn farmers (Ngbaka, Bagando, Monzombo), others are more mobile and traditionally hunter-gatherers, but now practice agriculture (Bayaka "Pygmies").

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Brief summary: 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: This project is composed by monkyepox disease outbreak investigation in the CAR following national surveillance framework.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of monkeypox cases occuring following interhuman exposures
timeFrame: 36 months
measure: Proportion of monkeypox cases occuring following zoonotic exposures
timeFrame: 36 months
Secondary outcomes:
measure: Measurement of the Effective reproduction rate R in CAR according to the level of immunity (smallpox vaccine immunity or orthopoxvirus-related post disease immunity).
timeFrame: 36 months
measure: measurement of the sensitivity and the specificity of the existing diagnostic tests and those developed within the framework of the project
timeFrame: 36 months
measure: 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
timeFrame: 36 months
measure: Comparison of genetic proximities between different viral strains isolated in humans and animals in CAR and neighboring countries since 1980.
timeFrame: 36 months
measure: Identification of the characteristics associated with the environments in which human cases of monkeypox virus infection have occurred
timeFrame: 36 months
Other outcomes:
Locations:
city: Bangui
country: Central African Republic
facility: Institut Pasteur Bangui
Study officials:
References:
citation: Besombes C, Gonofio E, Konamna X, Selekon B, Grant R, Gessain A, Berthet N, Manuguerra JC, Fontanet A, Nakoune E. Intrafamily Transmission of Monkeypox Virus, Central African Republic, 2018. Emerg Infect Dis. 2019 Aug;25(8):1602-1604. doi: 10.3201/eid2508.190112. Epub 2019 Aug 17.
citation: Berthet N, Descorps-Declere S, Besombes C, Curaudeau M, Nkili Meyong AA, Selekon B, Labouba I, Gonofio EC, Ouilibona RS, Simo Tchetgna HD, Feher M, Fontanet A, Kazanji M, Manuguerra JC, Hassanin A, Gessain A, Nakoune E. Genomic history of human monkey pox infections in the Central African Republic between 2001 and 2018. Sci Rep. 2021 Jun 22;11(1):13085. doi: 10.1038/s41598-021-92315-8.