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Evaluation of Effectiveness and Safety of LC16m8 Mpox Vaccine in the Democratic Republic of Congo (DRC)

NCT07093489 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 11990

Last updated 2025-09-15

No results posted yet for this study

Summary

This is a health facility-based prospective test-negative (TND) case-control study to evaluate vaccine effectiveness and active safety monitoring (cohort event monitoring), and passive surveillance for evaluation of the safety of the LC16m8 mpox vaccine in individuals aged one year and older in the DRC.

This study aims to assess the LC16m8 vaccine effectiveness and safety. The following activities will be carried out:

* Community engagement
* Enhanced health facility-based mpox disease surveillance
* Vaccination using the LC16m8 vaccine
* Safety monitoring following immunization
* LC16m8 Vaccine effectiveness evaluation using a TND

Study Hypothesis: The LC16m8 vaccine, administered as pre-exposure prophylaxis, confers greater than 70% protection against symptomatic mpox disease among adults and children in the DRC.

Conditions

  • Mpox (Monkeypox)
  • Mpox

Interventions

BIOLOGICAL

LC16m8

LC16m8 vaccine will be offered to all individuals aged \>1 year and meet the inclusion criteria within the catchment population. This will be done in line with the DRC government's LC16m8 vaccine roll out plan.

Sponsors & Collaborators

  • Japan Institute for Health Security (JIHS)

    collaborator UNKNOWN

  • Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo

    collaborator OTHER

  • International Vaccine Institute

    lead OTHER

Principal Investigators

  • Jean Jacques Muyembe · Institut National de la Recherche Biomédicale

  • Norio Ohmagari · Japan Institute for Health Security

  • Florian Marks · International Vaccine Institute

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2027-08-01
Completion
2027-12-31

Countries

  • Democratic Republic of the Congo

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07093489 on ClinicalTrials.gov