Actively Recruiting

Phase Not Applicable
Age: 5Years - 80Years
All Genders
Healthy Volunteers
ID06887556

Mpox Comprehensive Assessment for Responsive Immunisation in Emergency Outbreaks

Led by University of Birmingham · Updated on 2025-03-20

650

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Birmingham

Lead Sponsor

R

Rwanda Biomedical Centre

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating Mpox, a disease with rising cases in Central and East Africa, caused by two virus strains with different characteristics and spread patterns. The study aims to develop new immune tests to estimate how many people have been exposed to Mpox or vaccinated, helping to prioritize vaccine use in affected communities. This outbreak is considered a public health emergency due to increasing cases and deaths, especially with limited testing in some regions. Participants are grouped by their exposure status: those at risk but without symptoms, those recovered from Mpox or vaccinated, and those with no known exposure. The study uses diagnostic tests including an Mpox-specific antibody ELISA and a dried blood spot lateral flow assay to detect immune responses. All participants undergo the same testing procedures to assess their exposure or immunity status. During the study visit, participants provide biological samples for testing and complete surveys about their views on outbreak studies, immune diagnostic tools, and vaccine logistics. Researchers will measure Mpox-specific antibodies and evaluate rapid test accuracy. The study will also gather perspectives from healthcare workers and the public to support future vaccine strategies. The total participation involves sampling and questionnaires conducted on the first day.

CONDITIONS

Brief Title

Mpox Comprehensive Assessment for Responsive Immunisation in Emergency Outbreaks

Who Can Participate

Age: 5Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy males and females aged between 5 and 80 years who can provide informed consent and follow study requirements
  • For suspected exposure group: live within or near a Mpox transmission area or be a close contact of confirmed Mpox cases
  • For post-exposure/vaccinated group: previous confirmed Mpox infection or vaccination and fully recovered
  • For control group: asymptomatic with no known Mpox exposure
Not Eligible

You will not qualify if you...

  • Unable or unwilling to provide informed consent or comply with study procedures
  • History of immune system disorders that might affect study results
  • Significant bleeding disorders
  • Pregnant or breast-feeding females
  • Suspected exposure group: known Mpox infection, current Mpox symptoms, or recent exposure within one month
  • Post-exposure/vaccinated group: ongoing Mpox symptoms
  • Control group: Mpox symptoms or recent exposure within one month

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo diagnostic tests to detect Mpox exposure through antibody assays.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Rwanda Biomedical Center

Kigali, Rwanda, P.O. Box 7162

Actively Recruiting

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Research Team

S

Shema Hugor

K

Karishma Gokani

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

Frequently Asked Questions

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