AFRIPOX: A One Health Study of Monkeypox Human Infection

Sponsor

Institut Pasteur (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05058898

Collaborator

Institut Pasteur de Bangui (Other)

280

Enrollment

Location

26.7

Anticipated Duration (Months)

10.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Monkeypox Virus Infection	Other: blood samples Other: Scabs and pus samples

Detailed Description

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

280 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 9, 2021

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

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 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
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...).

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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