See if LC16m8 mpox vaccine protects people in the DRC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a facility-based, prospective test-negative case-control study that also monitors safety after vaccination. It uses a cohort event monitoring approach and passive safety surveillance to evaluate LC16m8 in a pre-exposure setting within defined health zones in the DRC. The study includes community engagement, enhanced disease surveillance, vaccination with LC16m8, and safety follow-up to determine vaccine effectiveness and safety outcomes. The hypothesis is that pre-exposure vaccination provides over 70% protection against symptomatic mpox among both adults and children.

Why it matters

Who can join: the full rules

1. Vaccination:

   Inclusion criteria
   * Individuals aged 12 months and above
   * Living in the study catchment area
   * Written informed consent/assent (if applicable)

   Exclusion criteria
   * Prior receipt of any mpox vaccine dose
   * Women known to be pregnant or breast feeding
   * Individuals suffering from any spreading skin disease
   * Immunocompromised individuals with known severe immuno-deficiency conditions (example, HIVAIDS, individuals being on chronic use of systemic steroids (\>2 mg/kg/day or \>20 mg/day prednisolone equivalent for periods exceeding 10 days, cytotoxic or other immunosuppressive drugs)
   * Individuals with known underlying uncontrolled chronic diseases such as diabetes mellitus, cardiovascular disease, renal disease, hepatic disease, hematological disease, and developmental disturbance
   * Individuals with a history of hypersensitivity caused by a component of the vaccine

   Temporary exclusion criteria
   * Individuals with objective fever (Frontal temperature ≥ 38.5°C) or axillary temperature \> 37.5 °C
   * Individuals suffering from acute illness within 48 hours prior to vaccination and based on investigator judgement.
   * Receipt of any live vaccine injection within the previous 27 days (measles vaccine, rubella vaccine, mumps vaccine, varicella vaccine, BCG vaccine, yellow fever vaccine...).
2. Cohort Event Monitoring (CEM):

   Inclusion criteria
   * Written informed consent
   * Individual who receives single dose of LC16m8 vaccine at one of the vaccination centers participating in the study.
   * Must be reachable by phone (must have an active phone number of his/her own or in the household) throughout study participation.

   Exclusion criteria

   • Individual/parent/guardian unable to comply with the study procedures
3. Mpox surveillance (VE):

General Inclusion Criteria:

* Patients (with any vaccination status) presenting to a sentinel surveillance health facility with clinical signs and symptoms consistent with mpox disease (probable or suspected)
* Reside in the study area prior to testing.
* Eligible to receive LC16m8 vaccine during the vaccination.
* Give consent/assent (if applicable) to participate in the study.

Exclusion Criteria

* Individuals meeting any of the following criteria are not eligible for testing and enrollment in the study:
* Known contraindications for LC16m8 vaccine.
* As per the Investigator's medical judgement, an individual could be excluded from the study despite meeting all the inclusion/exclusion criteria mentioned above.

Where it's running

• The Institut National de la Recherche Biomédicale (INRB)
  Kinshasa, Democratic Republic of the Congo Recruiting

Study contacts

• Principal investigator: Jean Jacques Muyembe — Institut National de la Recherche Biomédicale
• Study coordinator: Birkneh Tilahun Tadesse, MD
• Email: birkneh.tadesse@ivi.int
• Phone: +821098041348

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• mRNA vaccine (BNT166a) for mpox and smallpox prevention in adults in Africa

  This tests whether two doses of the mRNA vaccine BNT166a are safe and produce an immune response in healthy adults in Africa, including people who have or have not had prior smallpox or mpox exposure.

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• Assessing immune responses to Mpox in outbreak regions

  This study is trying to see how people's immune systems respond to the Mpox virus in outbreak areas by collecting samples from those who may have been exposed, infected, or vaccinated.

  Recruiting University of Birmingham · Kigali · NCT06887556

• Observational study of monkeypox infection in Brazil

  This study is trying to see how different health factors affect the risk and severity of monkeypox in people in Brazil.

  Recruiting at 3 sites Hospital Israelita Albert Einstein · Belém, Pará and 2 other locations · NCT05784038

• Understanding the spread and impact of monkeypox in the Democratic Republic of Congo

  This study is trying to understand how monkeypox spreads and affects people in the Democratic Republic of Congo by comparing those who have the virus to those who don’t.

  Recruiting Institute of Tropical Medicine, Belgium · Kinshasa, Masina and 1 other locations · NCT06840860

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.