Mpox Comprehensive Assessment for Responsive Immunisation in Emergency Outbreaks
MPOX CARE
1 other identifier
interventional
650
1 country
1
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 immune diagnostics that support models of disease burden and future vaccine utilisation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 5, 2025
CompletedFirst Submitted
Initial submission to the registry
February 18, 2025
CompletedFirst Posted
Study publicly available on registry
March 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
March 20, 2025
November 1, 2024
1.8 years
February 18, 2025
March 19, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Detection of anti-Mpox specific IgG antibody by ELISA
Number of patients in whom anti-Mpox specific IgG antibody is detected
Day 1
The clinical diagnostic performance of the RDT for Mpox exposure confirmation
A blood sample will be tested on the lateral flow device which will give a positive/negative result for the presence of antibody. This will be compared to the gold standard testing modality of ELISA. The MPox POC LFT performance versus ELISA will be characterised by test sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and likelihood ratios.
Day 1
Secondary Outcomes (3)
Perspectives of healthcare workers and the public on studies in response to outbreaks
Day 1
Perspectives of healthcare workers and the public on the development of novel immune diagnostic tools
Day 1
Perspectives of healthcare workers and the public on the vaccine cold-chain readiness to support public health measures
Day 1
Study Arms (1)
All participants
EXPERIMENTALAll participants will receive the same interventions.
Interventions
Dried blood spot lateral flow assay for Mpox antibody
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Birminghamlead
- Rwanda Biomedical Centrecollaborator
Study Sites (1)
Rwanda Biomedical Center
Kigali, P.O. Box 7162, Rwanda
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher Green
University of Birmingham
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2025
First Posted
March 20, 2025
Study Start
February 5, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
March 20, 2025
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data requests can be submitted starting immediately after article publication and the data will be made accessible for up to 5 years. Extensions will be considered on a case-by-case basis.
- Access Criteria
- Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a methodologically sound research proposal. Data must be required to achieve the aims in the approved proposal. Data requests should be directed to c.a.green.2@bham.ac.uk.
The data that support the findings of this study are not openly available to protect the confidentiality of study participants. Fully anonymised data are, however, available from the authors upon reasonable request.