Assessing immune responses to Mpox in outbreak regions
Mpox Comprehensive Assessment for Responsive Immunisation in Emergency Outbreaks
NA · University of Birmingham · NCT06887556
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 650 (estimated) |
| Ages | 5 Years to 80 Years |
| Sex | All |
| Sponsor | University of Birmingham (other) |
| Locations | 1 site (Kigali) |
| Trial ID | NCT06887556 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While there have been studies on Mpox, this approach focusing on novel immune diagnostics in outbreak settings is relatively novel and untested.
Eligibility criteria
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 this trial is running
Kigali
- Rwanda Biomedical Center — Kigali, Rwanda (RECRUITING)
Study contacts
- Principal investigator: Christopher Green — University of Birmingham
- Study coordinator: Shema Hugor
- Email: h.shema@cleancooling.org
- Phone: +250 791 207 333
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mpox