Epidemiological and Clinical Characteristics of Human Mpox Outbreak in Equateur Province in the Democratic Republic of Congo (Part3)

NCT06984705 | Enrolling By Invitation

• 1 other identifier: N553/BN/PMMF/2024-3
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate the effectiveness of smallpox vaccination administered before the global eradication of smallpox against currently circulating mpox in the Democratic Republic of the Congo. The main question it aims to answer is: Is the smallpox vaccine experience protective against mpox infection ? Researchers will compare mpox test positive group and negative group to see if the smallpox vaccine can protect against mpox infection. Participants will

• be included after informed consent,
• respond the survey with structured questionnaire
• and accept skin lesion and blood sampling.

Conditions

Mpox (Monkeypox)

Keywords

vaccine efficacy; test negative control

Outcome Measures

Primary Outcomes (1)

• Confirmed mpox

  Definition: the positivity of mpox is determined based on the gene amplification testing for mpox genes. The subjects sampled as suspected mpox patients will be classified based on pathogen diagnostic results: those testing positive will be defined as cases, and those testing negative will be defined as controls.

  Day 1

Secondary Outcomes (1)

• Severity

  Day 1

Study Arms (2)

cases

• Cases are defined as Individuals who reported to local health agents with symptoms consistent with mpox and subsequently tested positive for mpox through a molecular-based diagnostic test.

controls

Controls are defined as Individuals who reported to local health agents with symptoms consistent with mpox but subsequently tested negative for mpox through a molecular-based diagnostic test.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study targets patients born before 1984 with mpox-like skin lesions (both sexes) in the selected sites. All patients suspected of having mpox-like lesions and who provide proxy-assisted written informed consent to participate in the study are eligible for inclusion due to reduction of the risk of contact transmission with verbal agreement documented and confirmed by a witness. This approach prioritizes participant and staff safety while adhering to ethical standards.

You may qualify if:

• Individuals born before 1984: Although it is officially stated that smallpox vaccination was administered in the DRC until 1982, individuals born up to 1984 were included to account for potential discrepancies of several years in remote areas.
• Presence of skin lesions suspected to be mpox.
• Provision of informed consent:
• Proxy-assisted informed consent is allowed under safety considerations. Following oral consent, the investigator will document this on the informed consent form as a witness.

You may not qualify if:

• Participants will be excluded from the study under the following conditions:
• Refusal to participate in the study: Individuals who decline to provide consent for study participation will be excluded.

Sponsors & Collaborators

• Osaka Metropolitan University: lead
• Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo: collaborator

Study Sites (1)

Equateur Provincial Public Health Laboratory

Mbandaka, Équateur Province, Democratic Republic of the Congo

Location

Biospecimen

Retention: SAMPLES WITH DNA

Skin lesion and oral mucosa swab sample

MeSH Terms

Conditions

Mpox, Monkeypox

Condition Hierarchy (Ancestors)

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

Study Officials

• Natsuko Kaku, PhD

  Osaka Metropolitan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 22, 2025
• Study Start: July 31, 2025
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

DE (1)