NCT05879965 Prospective Study for the FOLLOW-UP of Human Monkeypox Cases and Smallpox Vaccinees at Risk
| NCT ID | NCT05879965 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institute of Tropical Medicine, Belgium |
| Condition | Monkeypox |
| Study Type | OBSERVATIONAL |
| Enrollment | 345 participants |
| Start Date | 2022-10-06 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 345 participants in total. It began in 2022-10-06 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Nicole Berens-Riha, PhD
PRINCIPAL INVESTIGATOR
Institute of Tropical Medicine
Frequently Asked Questions
Who can join the NCT05879965 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Monkeypox. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05879965 currently recruiting?
Yes, NCT05879965 is actively recruiting participants. Contact the research team at bsmekens@itg.be for enrollment information.
Where is the NCT05879965 trial being conducted?
This trial is being conducted at Antwerp, Belgium.
Who is sponsoring the NCT05879965 clinical trial?
NCT05879965 is sponsored by Institute of Tropical Medicine, Belgium. The principal investigator is Nicole Berens-Riha, PhD at Institute of Tropical Medicine. The trial plans to enroll 345 participants.