A One Health Study of Monkeypox Human Infection

NCT05058898 | Unknown

• 1 other identifier: 2019-047
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Monkeypox Virus Infection

Keywords

epidemiology; outbreak investigation; anthropology,; animal reservoir; zoonotic disease; field diagnosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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 sensitivity and the specificity of the existing diagnostic tests and those developed within the framework of the project

  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

  36 months

• Comparison of genetic proximities between different viral strains isolated in humans and animals in CAR and neighboring countries since 1980.

  36 months

• Identification of the characteristics associated with the environments in which human cases of monkeypox virus infection have occurred

  36 months

Study Arms (4)

Risk factors transmission cases

Human cases of monkeypox confirmed by PCR

Other: blood samples; Other: Scabs and pus samples

Risk factors transmission contacts and co-exposures

Human contact of confirmed monkeypox cases

Other: blood samples

Serological follow up cases

Human cases of monkeypox confirmed by PCR from Lobaye region

Other: blood samples; Other: Scabs and pus samples

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

Interventions

blood samples OTHER

5 mL

Risk factors transmission cases; Risk factors transmission contacts and co-exposures; Serological follow up cases; Serological follow up contacts and co-exposures

Scabs and pus samples OTHER

if available

Risk factors transmission cases; Serological follow up cases

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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"). Translated with www.DeepL.com/Translator (free version)

You may qualify if:

• 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

You may not qualify if:

• area not accessible to investigation
• refusal to participate
• inability to obtain consent

Sponsors & Collaborators

• Institut Pasteur: lead
• Institut Pasteur de Bangui: collaborator

Study Sites (1)

Institut Pasteur Bangui

Bangui, Central African Republic

Location

Related Publications (2)

• 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.

  PMID: 31216261 BACKGROUND

• 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.

  PMID: 34158533 BACKGROUND

Related Links

• Institut Pasteur Afripox

Biospecimen

Retention: SAMPLES WITH DNA

blood, scabs and pus

MeSH Terms

Conditions

Mpox, Monkeypox; Zoonoses

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Primate Diseases; Animal Diseases; Rodent Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: September 28, 2021
• Study Start: September 9, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CE (1)