Monkeypox, Biology, Outcome, Transmission and Epidemiology -Prospective Follow-up of High-risk Contacts (MBOTE-CONTACT)

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.

Study Overview

• Status: Completed
• Conditions: Mpox

• Study Type: Observational
• Enrollment (Actual): 257

Contacts and Locations

Study Locations

• Congo, The Democratic Republic of the
  • Maniema
    • Tunda, Maniema, Congo, The Democratic Republic of the
      • Tunda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• ▪ 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

  • 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

Exclusion Criteria:

• Having previously been diagnosed with mpox in the last 3 months
• Inability or unwillingness to comply with the proposed follow-up schedule

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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	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.	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.	21 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate pre- or asymptomatic infectiousness.	Number of PCR-positive samples from which MPXV can be cultured in cell culture.	21 days
To evaluate characteristics of the index cases that influence the risk of secondary infection.	Association between PCR positivity on any sample AND/OR symptomatic disease in the contact and characteristics of the index cases (included in PALM 007) including: disease severity of the index case; site of PCR positivity of the index case; viral load in samples obtained from the index case	21 days
To evaluate genomic differences in MPXV strains isolated from index and secondary cases	Whole genome sequencing of MPXV strains from index and secondary cases	21 days

Collaborators and Investigators

• Sponsor: Institute of Tropical Medicine, Belgium
• Collaborators: University of Manitoba; National Institute of Allergy and Infectious Diseases (NIAID); University of California, Los Angeles; Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo; Institut de Recherche pour le Developpement; Leidos Biomedical Research, Inc.; Alliance for International Medical Action
• Investigators: Principal Investigator: Laurens Liesenborghs, Prof., Institute of Tropical Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2023
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: November 14, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 7, 2025
• Last Update Submitted That Met QC Criteria: May 5, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Monkeypox
• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Poxviridae Infections; Monkeypox
• Other Study ID Numbers: 1657/22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No