A One Health Study of Monkeypox Human Infection

Active, not recruiting

• Conditions: Monkeypox Virus Infection
• Interventions: Other: blood samples; Other: Scabs and pus samples

• Registration Number: NCT05058898
• Lead Sponsor: Institut Pasteur

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.

Study Timeline

• Study Start: 2021-09-09
• Study First Submitted: 2021-09-24
• Study First Submitted QC: 2021-09-27
• Study First Posted: 2021-09-28
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-20
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 280

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Risk factors transmission cases	Scabs and pus samples	Human cases of monkeypox confirmed by PCR
Serological follow up cases	Scabs and pus samples	Human cases of monkeypox confirmed by PCR from Lobaye region
Serological follow up cases	blood samples	Human cases of monkeypox confirmed by PCR from Lobaye region
Serological follow up contacts and co-exposures	blood samples	Human contact of confirmed monkeypox cases from Lobaye region adjusted for age, month of the year and village of origin
Risk factors transmission cases	blood samples	Human cases of monkeypox confirmed by PCR
Risk factors transmission contacts and co-exposures	blood samples	Human contact of confirmed monkeypox cases

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Measurement of the Effective reproduction rate R in CAR according to the level of immunity (smallpox vaccine immunity or orthopoxvirus-related post disease immunity).	36 months	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).
measurement of the sensitivity and the specificity of the existing diagnostic tests and those developed within the framework of the project	36 months	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.
Identification of the characteristics associated with the environments in which human cases of monkeypox virus infection have occurred	36 months	ecosystems and their recent modifications, land use, associated climatic/meteorological elements in the tropical zone (CAR, Northern DRC...).
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	36 months	identification and interpretation of mutations, search for the common ancestor.
Comparison of genetic proximities between different viral strains isolated in humans and animals in CAR and neighboring countries since 1980.	36 months	Comparison of genetic proximities

Trial Locations

Locations (1)

Institut Pasteur Bangui; 🇨🇫 Bangui, Central African Republic