Prospective Study for the FOLLOW-UP of Human Monkeypox Cases and Smallpox Vaccinees at Risk

ConditionMonkeypox
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitute of Tropical Medicine, Belgium

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

345 Participants
are grouped into 3 trial groups
Group A: mpox patients
Group B: Smallpox vaccine recipients
Group C: Healthy controls

Trial outcomes

Primary outcomes

1

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

Time frame
2 years
2

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

Time frame
2 years

Secondary outcomes

1

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

Time frame
2 years

Other outcomes

Sponsors and contacts

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