Prospective Study for the FOLLOW-UP of Human Monkeypox Cases and Smallpox Vaccinees at Risk
Prospective On-site and Questionnaire Study for the FOLLOW-UP of Mpox Cohort at ITM PLUS Evaluation of the Longevity of B- and T-cell Immune Responses in Former Mpox Patients and Vaccine Recipients
Institute of Tropical Medicine, Belgium
345 participants
Oct 6, 2022
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria13
- Mpox patients for immunological study
- PCR-confirmed mpox infection since May 2022
- ≥18 years
- Willingness to provide written informed consent
- Willingness to follow the study schedule
- At least two smallpox vaccinations.
- ≥18 years
- Willingness to provide written informed consent
- Willingness to follow the study schedule
- On HIV-PrEP and a patient from ITM
- ≥18 years
- Willingness to provide written informed consent
- Willingness to follow the study schedule
Exclusion Criteria11
- Any vaccination 2 weeks before or after the visits (4 weeks for life-vaccines)
- Any mpox reinfection since study start
- Smallpox vaccinees for immunological study
- Any vaccination 2 weeks before or after the visits (4 weeks for life-vaccines)
- Any mpox infection in the past
- HIV-Prep patients
- 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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Locations(1)
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NCT05879965