An interventional study of ELISA and Lateral flow assay in Mpox, sponsored by University of Birmingham. Recruiting at 1 site in Rwanda. Open to participants aged 5 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-20.
Sponsored by University of Birmingham · Not applicable, Interventional, and Diagnostic
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.
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 circulating virus, clade Ia (previously known as clade I) in northwestern DRC primarily affecting children, and a new strain clade Ib in northeastern DRC which has since spread to bordering countries. The clade Ib strain, sub-lineage A was first identified in South Kivu. This strain has been found to have a APOBEC3-type mutations allowing increased circulation between humans. This novel clade is mainly characterized by the gene insertions and deletions including the deletion on C3L gene that effect the CDC recommended Clade I-specific real-time PCR detection. The WHO Director General declared the outbreak a public health emergency on 14th August 202433 as a result of escalating case numbers of both clade I strains. As of 28July 2024, this year there have been a total of 14,250 cases in 10 African countries, with a case fatality of 3.2%. This is likely to be an underestimate given the limited testing and healthcare capacity in some of the regions affected. The clade 1b Mpox outbreak is an urgent public health emergency in need of scientific countermeasures to control the spread of disease and protect African communities.
The primary clinical aim of this study to develop novel immune diagnostics to estimate Mpox's sero-prevalence and determine exposure to Mpox virus and/or previous vaccination as a tool for vaccine prioritization among at risk populations.
Participants will be recruited from the following groups:
Group 1 (suspected exposure cohort): asymptomatic volunteers at risk of Mpox including:
Group 2 (post-exposure/vaccinated cohort):
72 studies on the registry are indexed under Mpox, Monkeypox; 30 are open to participants now.
This study's planned enrollment of 650 is above the median of 305 across 36 interventional studies indexed under Mpox, Monkeypox.
Browse Mpox, Monkeypox studies →University of Birmingham is the lead sponsor of 182 studies on the registry; 29 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Group 1 (suspected exposure cohort) only
Group 2 (post-exposure/vaccinated cohort) only
Group 3 (control cohort) only:
Exclusion Criteria:
Group 1 (suspected exposure cohort) only
Group 2 (post-exposure/vaccinated cohort) only
Group 3 (control cohort only)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants will receive the same interventions.
Diagnostic Test: ELISA · Diagnostic Test: Lateral flow assay
Mpox-specific antibody ELISA
Dried blood spot lateral flow assay for Mpox antibody
Detection of anti-Mpox specific IgG antibody by ELISA
Number of patients in whom anti-Mpox specific IgG antibody is detected
Time frame: 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.
Time frame: Day 1
Perspectives of healthcare workers and the public on studies in response to outbreaks
Qualitative analysis of output from focus group discussion regarding taking part in this trial
Time frame: Day 1
Perspectives of healthcare workers and the public on the development of novel immune diagnostic tools
Qualitative analysis of focus groups with the healthcare workers and the public who have taken part in the study around this topic.
Time frame: Day 1
Perspectives of healthcare workers and the public on the vaccine cold-chain readiness to support public health measures
Qualitative analysis of focus groups with the healthcare workers and the public who have taken part in the study around this topic.
Time frame: Day 1
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
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.
No publications or documents are linked to this record.
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