Health Trials

Mpox Comprehensive Assessment for Responsive Immunisation in Emergency Outbreaks

ConditionMpox
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-80
SponsorUniversity of Birmingham

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • ELISA

    Diagnostic test

    Mpox-specific antibody ELISA

  • Lateral flow assay

    Diagnostic test

    Dried blood spot lateral flow assay for Mpox antibody

Treatment groups

650 Participants
are divided into 1 treatment group
Group A: All participantsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

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
2

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
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Birmingham

Lead sponsor

Rwanda Biomedical Centre

Collaborator

Source ClinicalTrials.gov
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