Clinical trial NCT06136117: Monkeypox, Biology, Outcome, Transmission and Epidemiology -Prospective Follow-up of High-risk Contacts
Official title: Mpox, Biology, Outcome, Transmission and Epidemiology - Prospective Follow-up of High-risk Contacts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mpox
Keywords: Monkeypox
Lead sponsor: Institute of Tropical Medicine, Belgium
Sponsor class: OTHER
Collaborators: name: Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Leidos Biomedical Research, Inc.
name: Alliance for International Medical Action
name: University of California, Los Angeles
name: Institut de Recherche pour le Developpement
name: University of Manitoba
First posted: 2023-11-18
Enrollment: 257
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Study human-to-human transmission of Mpox virus (MPXV) by determining the secondary attack rate (SAR) among high-risk contacts of index patients.
timeFrame: 21 days
Secondary outcomes:
measure: To determine the rate of seroconversion amongst high-risk contacts of index patients.
timeFrame: 21 days
measure: To estimate the extent of asymptomatic shedding of MPXV.
timeFrame: 21 days
measure: To estimate the extent of presymptomatic shedding of MPXV.
timeFrame: 21 days
measure: To estimate the duration between start of viral shedding and the appearance of prodromal symptoms.
timeFrame: 21 days
measure: To estimate the incubation period of MPXV.
timeFrame: 21 days
measure: To characterize the clinical presentation of symptomatic secondary cases.
timeFrame: 21 days
measure: To evaluate risk factors for infection and/or symptomatic disease.
timeFrame: 21 days
measure: To evaluate the protective effect of previous small pox vaccinations against infection and/or symptomatic disease.
timeFrame: 21 days
measure: To estimate the duration between start of viral shedding and the appearance of skin symptoms.
timeFrame: 21 days
Other outcomes:
measure: To evaluate pre- or asymptomatic infectiousness.
timeFrame: 21 days
measure: To evaluate characteristics of the index cases that influence the risk of secondary infection.
timeFrame: 21 days
measure: To evaluate genomic differences in MPXV strains isolated from index and secondary cases
timeFrame: 21 days
Locations:
city: Tunda
country: Congo, The Democratic Republic of the
facility: Tunda
state: Maniema
Study officials:
affiliation: Institute of Tropical Medicine
name: Laurens Liesenborghs, Prof.
role: PRINCIPAL_INVESTIGATOR
References: