Prospective Study for the FOLLOW-UP of Human Monkeypox Cases and Smallpox Vaccinees at Risk (NCT05879965) | Clinical Trial Compass
RecruitingNot Applicable
Prospective Study for the FOLLOW-UP of Human Monkeypox Cases and Smallpox Vaccinees at Risk
Belgium345 participantsStarted 2022-10-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of individuals with a positive mpox serology in both groups
Timeframe: 2 years
2
Proportion of long-term problems or sequelae in mpox patients