RecruitingNot ApplicableNCT06887556
Mpox Comprehensive Assessment for Responsive Immunisation in Emergency Outbreaks
Sponsor
University of Birmingham
Enrollment
650 participants
Start Date
Feb 5, 2025
Study Type
INTERVENTIONAL
Conditions
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 immune diagnostics that support models of disease burden and future vaccine utilisation.
Eligibility
Min Age: 5 YearsMax Age: 80 Years
Inclusion Criteria9
- 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 Criteria14
- 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
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Interventions
DIAGNOSTIC_TESTELISA
Mpox-specific antibody ELISA
DIAGNOSTIC_TESTLateral flow assay
Dried blood spot lateral flow assay for Mpox antibody
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06887556