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 Type
OBSERVATIONAL
Enrollment
257
Tunda
Tunda, Maniema Province, Democratic Republic of the Congo
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.
Time frame: 21 days
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 21 days
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