A One Health Study of Monkeypox Human Infection

Monkeypox Virus Infection Clinical Trial

— AFRIPOX  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05058898
• Other study ID #: 2019-047
• Status: Active, not recruiting
• Start date: September 9, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2023
• Source: Institut Pasteur
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 280
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Monkeypox
• Monkeypox Virus Infection

Intervention

Other:
• blood samples
5 mL
• Scabs and pus samples
if available

Locations

Country	Name	City	State
Central African Republic	Institut Pasteur Bangui	Bangui

Sponsors (2)

Lead Sponsor	Collaborator
Institut Pasteur	Institut Pasteur de Bangui

Country where clinical trial is conducted

Central African Republic, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Institut Pasteur Afripox