MpoxMPOX CARENCT06887556
Mpox Comprehensive Assessment for Responsive Immunisation in Emergency Outbreaks
A study testing ELISA and Lateral flow assay in people with Mpox, run by University of Birmingham at 1 site in Rwanda.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Mpox
- What is being tested?
- ELISA and Lateral flow assay
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 1 siteRwanda
- Study dates
- 5 Feb 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Fully recovered from Mpox infection
- Group 3 (control cohort) only:
- Asymptomatic with no known exposure to Mpox
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Karishma Gokani contact
Rwanda1 site, 1 recruiting
- Recruiting
Rwanda Biomedical Center
Kigali, P.O. Box 7162
Jean Pierre Musabyimana, +250788299096, jpierre.musabyimana@rbc.gov.rw
About this study
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.
Read the detailed description
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:
- Those who live within or adjacent to, or spend prolonged amounts of time in an epidemiologically identified region of Mpox transmission
- Close contacts of those with microbiologically confirmed Mpox
- Group 2 (post-exposure/vaccinated cohort):
- asymptomatic volunteers who have had clinically or microbiologically confirmed Mpox infection within the last one-month (group 2a) or more than one-month ago (group 2b)
- Those who have received a smallpox/MVA vaccine within the last one-month (group 2c) or more than one-month ago (group 2d)
- Group 3 (control cohort): asymptomatic volunteers with no known exposure to Mpox
- Conditions
- Mpox
- Being tested
- ELISA, Lateral flow assay
- Medical subject headings
- Mpox, Monkeypox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELISADiagnostic test
Mpox-specific antibody ELISA
Lateral flow assayDiagnostic test
Dried blood spot lateral flow assay for Mpox antibody
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | All participants will receive the same interventions. Receives: Diagnostic Test: ELISA; Diagnostic Test: Lateral flow assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of anti-Mpox specific IgG antibody by ELISA
Number of patients in whom anti-Mpox specific IgG antibody is detected
Measured: 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.
Measured: Day 1
Secondary outcomes (3)
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
Measured: 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.
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start5 Feb 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MpoxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Rwanda Biomedical Centre
- Responsible party
- Sponsor
- Investigators
- Christopher Green, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887556
- Sponsor's protocol ID
- Mpox CARE
- Acronym
- MPOX CARE
- Status last verified
- Nov 2024
- First submitted
- 18 Feb 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Gokani K, Semukunzi H, Rukundo G, Clarke J, Faustini SE, Musabyimana JP, Roche S, Jones S, Otter AD, Richter A, Muvunyi C, Heaney J, Green CA; MpoxCARE Study Group. Mpox comprehensive assessment for responsive immunisation in emergency outbreaks (MpoxCARE): study protocol. BMC Infect Dis. 2026 Feb 13;26(1):590. doi: 10.1186/s12879-026-12809-6.
PubMed 41688920
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mpox Comprehensive Assessment for Responsive Immunisation in Emergency Outbreaks
- ClinicalTrials.gov ID
- NCT06887556
- Acronym / sponsor ID
- MPOX CARE / Mpox CARE
- Conditions
- Mpox
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- Rwanda Biomedical Centre
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Those who live within or adjacent to, or spend prolonged amounts of time in an epidemiologically identified region of Mpox transmission
- Close contacts of those with microbiologically confirmed Mpox
- Group 2 (post-exposure/vaccinated cohort):
- asymptomatic volunteers who have had clinically or microbiologically confirmed Mpox infection within the last one-month (group 2a) or more than one-month ago (group 2b)
- Those who have received a smallpox/MVA vaccine within the last one-month (group 2c) or more than one-month ago (group 2d)
- Group 3 (control cohort): asymptomatic volunteers with no known exposure to Mpox
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Diagnostic Test: ELISA, Diagnostic Test: Lateral flow assayAll participants will receive the same interventions. |
Who may qualify
- Ages
- 5 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- Group 2 (post-exposure/vaccinated cohort) only
- Group 3 (control cohort) only:
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELISAMpox-specific antibody ELISA | Diagnostic test | All participants |
| Lateral flow assayDried blood spot lateral flow assay for Mpox antibody | Diagnostic test | All participants |
Primary outcome
Detection of anti-Mpox specific IgG antibody by ELISA
Time frame: Day 1
Number of patients in whom anti-Mpox specific IgG antibody is detected
The clinical diagnostic performance of the RDT for Mpox exposure confirmation
Time frame: Day 1
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.
3 secondary outcomes
Perspectives of healthcare workers and the public on studies in response to outbreaks
Time frame: Day 1
Perspectives of healthcare workers and the public on the development of novel immune diagnostic tools
Time frame: Day 1
Perspectives of healthcare workers and the public on the vaccine cold-chain readiness to support public health measures
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Derived from this study: PubMed 41688920Gokani K, Semukunzi H, Rukundo G, Clarke J, Faustini SE, Musabyimana JP, Roche S, Jones S, Otter AD, Richter A, Muvunyi C, Heaney J, Green CA; MpoxCARE Study Group. Mpox comprehensive assessment for responsive immunisation in emergency outbreaks (MpoxCARE): study protocol. BMC Infect Dis. 2026 Feb 13;26(1):590. doi: 10.1186/s12879-026-12809-6.
- Individual participant dataSharing planned: 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.
Related trials for Mpox
RecruitingObservational study
Evaluation of Effectiveness and Safety of LC16m8 Mpox Vaccine in the Democratic Republic of Congo (DRC)
Mpox (Monkeypox), Mpox
Enrolling by invitationObservational study
New York City Observational Study of Mpox Immunity
Monkeypox, Mpox
Enrolling by invitation
Smart Analysis and Decision-Making for Emerging Infectious Diseases
Emerging Infectious Diseases, COVID-19
Active, not recruitingPhase 4
Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster RCT
Monkeypox
RecruitingPhase 2
A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in Africa
Mpox (Monkeypox), Smallpox
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karishma Gokani contact
Christopher Green principal investigator
University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ELISA and Lateral flow assay in people with Mpox, run by University of Birmingham at 1 site in Rwanda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shema Hugor (+250 791 207 333, h.shema@cleancooling.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of anti-Mpox specific IgG antibody by ELISA (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06887556, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025; AzTrials last refreshed its copy on 30 Oct 2026.