Status:
RECRUITING
Mpox Comprehensive Assessment for Responsive Immunisation in Emergency Outbreaks
Lead Sponsor:
University of Birmingham
Collaborating Sponsors:
Rwanda Biomedical Centre
Conditions:
Mpox
Eligibility:
All Genders
5-80 years
Phase:
NA
Brief Summary
The MPXV CARE study principally aims to use clinical and epidemiology data to target specific individuals willing and able to provide appropriate and proportionate biological samples to develop novel ...
Detailed Description
Cases of Mpox in Central and East Africa have been climbing since December 2022 when Democratic Republic of Congo (DRC) declared a national outbreak of the disease. There are two strains of circulatin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
650 Patients enrolled
Trial Details
Trial ID
NCT06887556
Start Date
February 5 2025
End Date
December 1 2026
Last Update
March 20 2025
Active Locations (1)
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1
Rwanda Biomedical Center
Kigali, Rwanda, P.O. Box 7162