Monkeypox, Biology, Outcome, Transmission and Epidemiology -Prospective Follow-up of High-risk Contacts

NCT06136117 | Completed

• 1 other identifier: 1657/22
• Study Type: observational
• Target: 257
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• To determine the rate of seroconversion amongst high-risk contacts of index patients.

  21 days

• To estimate the extent of asymptomatic shedding of MPXV.

  21 days

• To estimate the extent of presymptomatic shedding of MPXV.

  21 days

• To estimate the duration between start of viral shedding and the appearance of prodromal symptoms.

  21 days

• To estimate the incubation period of MPXV.

  21 days

Other Outcomes (3)

• To evaluate pre- or asymptomatic infectiousness.

  21 days

• To evaluate characteristics of the index cases that influence the risk of secondary infection.

  21 days

• To evaluate genomic differences in MPXV strains isolated from index and secondary cases

  21 days

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ▪ 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

You may not qualify if:

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

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead
• Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Leidos Biomedical Research, Inc.: collaborator
• Alliance for International Medical Action: collaborator
• University of California, Los Angeles: collaborator
• Institut de Recherche pour le Developpement: collaborator
• University of Manitoba: collaborator

Study Sites (1)

Tunda

Tunda, Maniema Province, Democratic Republic of the Congo

Location

MeSH Terms

Conditions

Mpox, Monkeypox

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Primate Diseases; Animal Diseases; Rodent Diseases

Study Officials

• Laurens Liesenborghs, Prof.

  Institute of Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: November 18, 2023
• Study Start: May 22, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: May 7, 2025

Record last verified: 2025-05

Locations

DE (1)