MpoxMBOTE-CONTACTNCT06136117
Monkeypox, Biology, Outcome, Transmission and Epidemiology -Prospective Follow-up of High-risk Contacts
An observational study of Mpox, run by Institute of Tropical Medicine, Belgium at 1 site in Democratic Republic of the Congo.
Trial summary
With the MBOTE-CONTACT study, a detailed follow-up study of high-risk contacts of mpox patients will be done. The MBOTE-CONTACT study will be nested in the NIH-Funded PALM-007 clinical trial (NCT05559099) and the MBOTE project on mpox transmission. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mpox
- How many people
- 257 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- 22 May 2023to 1 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study will take place in parallel to the PALM007 clinical trial, which evaluates the safety and efficacy of tecovirimat for the treatment of mpox. The study will recruit in Tunda, Maniema Province as well as in Kole, Sankuru province. These are the two sites where the PALM-007 has started. The study may expand to other potential PALM007 study sites, including Boende (Tshuappa Province), depending on the case burden and epidemiological context.Participants will be recruited among high-risk contacts of laboratory-confirmed mpox cases included in the ongoing PALM007 trial.Participants will be recruited according to two strategic tracks centered around 1) the study center and 2) the community.
Who may be able to join
- ▪ Be a high-risk contact of a laboratory-confirmed mpox case, with high-risk defined as having at least one the following types of exposure:
- living in the same household as an mpox patient
- having had sexual contact or intercourse with an mpox patient
- sleeping in the same room as an mpox patient
- sharing a meal with an mpox patient
- children: having played together
Show all 9Show fewer
- Last exposure to the mpox index case of less than 14 days ago
- Patients of any age and gender (children aged < 10 years are excluded from venous blood sampling)
- Patient or culturally acceptable representative is willing and able to give informed consent for participation in the study
Who cannot join
- Having previously been diagnosed with mpox in the last 3 months
- Inability or unwillingness to comply with the proposed follow-up schedule
Trial locations and contacts
1 site in 1 country.
Democratic Republic of the Congo1 site
Tunda
Tunda, Maniema Province
About this study
Official title: Mpox, Biology, Outcome, Transmission and Epidemiology - Prospective Follow-up of High-risk Contacts
With the MBOTE-CONTACT study, a detailed follow-up study of high-risk contacts of mpox patients will be done. The MBOTE-CONTACT study will be nested in the NIH-Funded PALM-007 clinical trial (NCT05559099) and the MBOTE project on mpox transmission. The study will take place in Maniema Province, Democratic Republic of Congo (DRC). Participants will be recruited among high-risk contacts of mpox patients included in the PALM-007 trial. Consenting contacts will be either followed daily at the central study site or visited weekly by an outreach team in the community. They will be examined daily for signs and symptoms and asked to provide daily saliva and weekly blood samples for polymerase chain reaction (PCR) and/or serology. If participants develop mpox, they are offered treatment and enrollment in the PALM-007 trial.
- Conditions
- Mpox
- Keywords
- Monkeypox
- Medical subject headings
- Mpox, Monkeypox
What is being measured
The primary outcome is the main question the study is designed to answer.
Study human-to-human transmission of Mpox virus (MPXV) by determining the secondary attack rate (SAR) among high-risk contacts of index patients.
Proportion of high-risk contacts with a positive MPXV PCR on any sample within 21 days after inclusion.
Measured: 21 days
Secondary outcomes (9)
To determine the rate of seroconversion amongst high-risk contacts of index patients.
The proportion of high-risk contacts with seroconversion for mpox antibodies on day 21 compared to baseline.
Measured: 21 days
To estimate the extent of asymptomatic shedding of MPXV.
PCR positivity in any sample (blood, saliva) among participants who do not have any symptoms at the moment of sampling, but develop symptoms later during follow-up.
Measured: 21 days
To estimate the extent of presymptomatic shedding of MPXV.
PCR positivity in any sample (blood, saliva) among participants who do not have any symptoms at the moment of sampling, but develop symptoms later during follow-up.
Measured: 21 days
To estimate the duration between start of viral shedding and the appearance of prodromal symptoms.
Time between PCR positivity in any sample and appearance of systemic symptoms: either adenopathy, fever or dysphagia.
Measured: 21 days
To estimate the incubation period of MPXV.
Time from last exposure to first PCR positivity. Time from last exposure to appearance of any symptom. Time from last exposure to appearance of skin lesions.
Measured: 21 days
To characterize the clinical presentation of symptomatic secondary cases.
Frequency, timing and type of signs and symptoms observed among participants with a positive PCR.
Measured: 21 days
To evaluate risk factors for infection and/or symptomatic disease.
Number of contacts with positive PCR on any sample AND/OR symptomatic disease and one of the following factors:
- Different types of contact with the index case
- Exposure to the same animal reservoir as the index case
- Being vaccinated against mpox
- Sociodemographic factors
Measured: 21 days
To evaluate the protective effect of previous small pox vaccinations against infection and/or symptomatic disease.
number of previous vaccinate contacts positive PCR on any sample AND/OR symptomatic disease.
Measured: 21 days
To estimate the duration between start of viral shedding and the appearance of skin symptoms.
Time between PCR positivity in any sample and appearance of skin lesions.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start22 May 2023
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de Recherche Biomedicale (INRB), National Institute of Allergy and Infectious Diseases (NIAID), Leidos Biomedical Research, Inc., Alliance for International Medical Action, University of California, Los Angeles, Institut de Recherche pour le Developpement, University of Manitoba
- Responsible party
- Sponsor
- Investigators
- Laurens Liesenborghs, Prof., Principal investigator, Institute of Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06136117
- Sponsor's protocol ID
- 1657/22
- Acronym
- MBOTE-CONTACT
- Status last verified
- May 2025
- First submitted
- 4 May 2023
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mpox, Biology, Outcome, Transmission and Epidemiology - Prospective Follow-up of High-risk Contacts
- ClinicalTrials.gov ID
- NCT06136117
- Acronym / sponsor ID
- MBOTE-CONTACT / 1657/22
- Conditions
- Mpox
- Keywords
- Monkeypox
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- Institut National de Recherche Biomedicale (INRB), National Institute of Allergy and Infectious Diseases (NIAID), Leidos Biomedical Research, Inc., Alliance for International Medical Action, University of California, Los Angeles, Institut de Recherche pour le Developpement, University of Manitoba
- Study start
- 22 May 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 18 Nov 2023 (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.
With the MBOTE-CONTACT study, a detailed follow-up study of high-risk contacts of mpox patients will be done. The MBOTE-CONTACT study will be nested in the NIH-Funded PALM-007 clinical trial (NCT05559099) and the MBOTE project on mpox transmission. The study will take place in Maniema Province, Democratic Republic of Congo (DRC). Participants will be recruited among high-risk contacts of mpox patients included in the PALM-007 trial. Consenting contacts will be either followed daily at the central study site or visited weekly by an outreach team in the community. They will be examined daily for signs and symptoms and asked to provide daily saliva and weekly blood samples for polymerase chain reaction (PCR) and/or serology. If participants develop mpox, they are offered treatment and enrollment in the PALM-007 trial.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will take place in parallel to the PALM007 clinical trial, which evaluates the safety and efficacy of tecovirimat for the treatment of mpox. The study will recruit in Tunda, Maniema Province as well as in Kole, Sankuru province. These are the two sites where the PALM-007 has started. The study may expand to other potential PALM007 study sites, including Boende (Tshuappa Province), depending on the case burden and epidemiological context.Participants will be recruited among high-risk contacts of laboratory-confirmed mpox cases included in the ongoing PALM007 trial.Participants will be recruited according to two strategic tracks centered around 1) the study center and 2) the community.
Key inclusion criteria (9 listed)
- ▪ Be a high-risk contact of a laboratory-confirmed mpox case, with high-risk defined as having at least one the following types of exposure:
- living in the same household as an mpox patient
- having had sexual contact or intercourse with an mpox patient
- sleeping in the same room as an mpox patient
- sharing a meal with an mpox patient
Key exclusion criteria (2 listed)
- Having previously been diagnosed with mpox in the last 3 months
- Inability or unwillingness to comply with the proposed follow-up schedule
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Study human-to-human transmission of Mpox virus (MPXV) by determining the secondary attack rate (SAR) among high-risk contacts of index patients.
Time frame: 21 days
Proportion of high-risk contacts with a positive MPXV PCR on any sample within 21 days after inclusion.
9 secondary outcomes
To determine the rate of seroconversion amongst high-risk contacts of index patients.
Time frame: 21 days
To estimate the extent of asymptomatic shedding of MPXV.
Time frame: 21 days
To estimate the extent of presymptomatic shedding of MPXV.
Time frame: 21 days
To estimate the duration between start of viral shedding and the appearance of prodromal symptoms.
Time frame: 21 days
To estimate the incubation period of MPXV.
Time frame: 21 days
To characterize the clinical presentation of symptomatic secondary cases.
Time frame: 21 days
To evaluate risk factors for infection and/or symptomatic disease.
Time frame: 21 days
To evaluate the protective effect of previous small pox vaccinations against infection and/or symptomatic disease.
Time frame: 21 days
To estimate the duration between start of viral shedding and the appearance of skin symptoms.
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
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. This study is not recruiting at the moment.
Laurens Liesenborghs, Prof. principal investigator
Institute of Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mpox, run by Institute of Tropical Medicine, Belgium at 1 site in Democratic Republic of the Congo.
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 2 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: finished, as of the sponsor's last update on 7 May 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 Democratic Republic of the Congo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study human-to-human transmission of Mpox virus (MPXV) by determining the secondary attack rate (SAR) among high-risk contacts of index patients. (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2025.