Actively Recruiting
Prospective Study for the FOLLOW-UP of Human Monkeypox Cases and Smallpox Vaccinees at Risk
Led by Institute of Tropical Medicine, Belgium · Updated on 2026-03-19
345
Participants Needed
1
Research Sites
295 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prospective Study for the FOLLOW-UP of Human Monkeypox Cases and Smallpox Vaccinees at Risk
Who Can Participate
Eligibility Criteria
You may qualify if you...
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
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Trial Site Locations
Total: 1 location
1
Institute of Tropical Medicine
Antwerp, Belgium, 2000
Actively Recruiting
Research Team
S
Study Coordinator
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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