About this trial
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
This trial does not accept healthy volunteersQualifiers
PCR-confirmed mpox infection since May 2022
≥18 years
Willingness to provide written informed consent
Willingness to follow the study schedule
Disqualifiers
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
At least two smallpox vaccinations.
Trial population
Former mpox patients ≥18 years, diagnosed by PCR at ITM since May 2022 Smallpox vaccine recipients vaccinated at ITM since August 2022 Healthy HIV-PrEP users
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Proportion of individuals with a positive mpox serology in both groups
To compare the MPXV-specific serological response in naturally infected mpox male patients 8, 16 and 24 months after onset of symptoms with the MPXV-specific serological response in routinely (=2 either subcutaneous (SC) or intradermal (ID) vaccinations with an interval of 4-8 weeks) vaccinated men against smallpox 8 months after the first vaccination
Proportion of long-term problems or sequelae in mpox patients
To describe any possible long-term problem or sequela after an acute human mpox infection diagnosed and confirmed by PCR at ITM since the beginning of the mpox outbreak End of May 2022
Secondary outcomes
longevity of humoral and/or cellular immune response to mpox or vaccinia virus
B-cell and T-cell characteristics in former mpox patients and smallpox vaccinees 8, 16, 24 months after symptom
Sponsors and contacts
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