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Prospective Study for the FOLLOW-UP of Human Monkeypox Cases and Smallpox Vaccinees at Risk

Recruitingn/aAges 18 Years - anyAllInstitute of Tropical Medicine, Belgium
NCT05879965 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this observational study is to describe possible physical and psychological sequelae after an mpox infection and to evaluate the longevity of B- and T-cell immune responses in former mpox patients and vaccine recipients. The main questions it aims to answer are: * Are there any physical or pschological sequelae after mpox infection? * Is the humoral and/or cellular immune response to MPOX (or vaccinia) virus) durable? * Do the patients develop strong local immunity in comparison to systemic immunity? * How long is the virus still detectable in semen, saliva or the ano-rectal region? Participants will answer a questionnaire, samples with blood, saliva and semen as well as anal swabs will be collected. Follow-up visits 8, 16 and 24, 36, 48, and 60 months after infection or vaccination are planned. A healthy control group will be recruited in our HIV-PrEP clinic.

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📋 Eligibility rules (as published)
Mpox patients for immunological study Inclusion criteria * PCR-confirmed mpox infection since May 2022 * ≥18 years * Willingness to provide written informed consent * Willingness to follow the study schedule Exclusion criteria * Any vaccination 2 weeks before or after the visits (4 weeks for life-vaccines) * Any immune-compromising drugs or diseases (treated and controlled HIV-infection is no exclusion criteria) * Any mpox reinfection since study start Smallpox vaccinees for immunological study Inclusion criteria * At least two smallpox vaccinations. * ≥18 years * Willingness to provide written informed consent * Willingness to follow the study schedule Exclusion criteria * Any vaccination 2 weeks before or after the visits (4 weeks for life-vaccines) * Any immune-compromising drugs or diseases (treated and controlled HIV-infection is no exclusion criteria) * Any mpox infection in the past HIV-Prep patients Inclusion criteria * On HIV-PrEP and a patient from ITM * ≥18 years * Willingness to provide written informed consent * Willingness to follow the study schedule Exclusion criteria * Born before 1976 * Any documented or remembered smallpox vaccination or typical scar for a smallpox vaccination * Any vaccination 2 weeks before or after the visits (4 weeks for life-vaccines) * Any immune-compromising drugs or diseases * Any mpox infection in the past
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What it tests

  • Not listed
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Where

1 site
Institute of Tropical Medicine
Antwerp, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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