Clinical trial Recruiting at 1 site Interventional Ages 5 to 80

Assessing immune responses to Mpox in outbreak regions

Official title: Mpox Comprehensive Assessment for Responsive Immunisation in Emergency Outbreaks

Run by University of Birmingham · NCT06887556 · Data updated 2026-11-12

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.

Quick facts

Study typeInterventional
Ages5 Years to 80 Years
SexAll
Enrollment650 (estimated)
SponsorUniversity of Birmingham
Academic / other
Locations1 site (Kigali)
StatusRecruiting
StartedFebruary 5, 2025
Main results expectedDecember 2026
Study endsDecember 2026
Registry record updatedMarch 20, 2025
Trial IDNCT06887556 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include healthy individuals aged 5-80 who live in or near areas with Mpox transmission and are willing to provide informed consent.

Probably not a fit

Patients with a history of immune system disorders or those unable to comply with study procedures may not benefit from this study.

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

What this trial studies

This study aims to gather clinical and epidemiological data to develop new immune diagnostics for Mpox, particularly in regions experiencing outbreaks. It focuses on individuals who can provide biological samples to help estimate the sero-prevalence of the virus and assess exposure levels. The study will involve various cohorts, including those with suspected exposure, those previously infected or vaccinated, and asymptomatic controls. The research is crucial in understanding the disease's spread and informing future vaccination strategies.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic tools and strategies for controlling Mpox outbreaks.

How similar studies have gone: While there have been studies on Mpox, this approach focusing on novel immune diagnostics in outbreak settings is relatively novel and untested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Healthy males and females aged between ages 5-80 years, who are able and willing to provide informed consent and will comply with the study requirements.
* Group 1 (suspected exposure cohort) only

  * Live within or adjacent to an epidemiologically identified region of Mpox transmission
  * Close contacts of those with microbiologically confirmed Mpox
* Group 2 (post-exposure/vaccinated cohort) only

  * Previous clinically or microbiologically confirmed Mpox or confirmed previous vaccination with a smallpox/MVA vaccine
  * Fully recovered from Mpox infection
* Group 3 (control cohort) only:

  * Asymptomatic with no known exposure to Mpox

Exclusion Criteria:

* Unwilling or unable to provide informed consent to take part
* Unwilling or unable to comply with study procedures
* History of any suspected or confirmed disorder of the immune system that, in the opinion of the investigators, might impair the results of the study
* Have a bleeding disorder deemed significant by a member of the study team
* Pregnant or breast-feeding females
* Group 1 (suspected exposure cohort) only

  * Known history of Mpox infection
  * Current symptoms consistent with Mpox
  * Known exposure to Mpox in the last month
* Group 2 (post-exposure/vaccinated cohort) only

  * Participants with any ongoing symptoms of Mpox, indicating incomplete recovery.
* Group 3 (control cohort only)

  * Symptoms of Mpox
  * Known exposure to Mpox in the last month

Where it's running

  • Rwanda Biomedical Center
    Kigali, Rwanda
    Recruiting

Study contacts

Similar studies

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

  • Mpox sample collection with SDS-EDTA paper strips in DRC

    A study tests whether SDS-EDTA-treated chromatography paper strips can collect mpox samples as well as standard swabs for lab testing in people with suspected mpox in South Kivu, DRC.

    Recruiting Universitaire Ziekenhuizen KU Leuven · Bukavu · NCT07634081

  • See if LC16m8 mpox vaccine protects people in the DRC

    This study tests whether the LC16m8 mpox vaccine helps prevent mpox in people aged 12 months and older in the DRC.

    Recruiting International Vaccine Institute · Kinshasa · NCT07093489

  • 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

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.