Monkeypox Clinical Trials

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Prospective On-site and Questionnaire Study for the FOLLOW-UP of Mpox Cohort at ITM PLUS Evaluation of the Longevity of B- and T-cell Immune Responses in Former Mpox Patients and Vaccine Recipients

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• PCR-confirmed mpox infection since May 2022

• ≥18 years

• Willingness to provide written informed consent

• Willingness to follow the study schedule

• At least two smallpox vaccinations.

• ≥18 years

• Willingness to provide written informed consent

• Willingness to follow the study schedule

• On HIV-PrEP and a patient from ITM

• ≥18 years

• Willingness to provide written informed consent

• Willingness to follow the study schedule

Locations
Other Locations
Belgium
Institute of Tropical Medicine
RECRUITING
Antwerp
Contact Information
Primary
Study Coordinator
bsmekens@itg.be
+32(0)33455672
Time Frame
Start Date: 2022-10-06
Estimated Completion Date: 2028-06
Participants
Target number of participants: 345
Treatments
mpox patients
mpox cohort diagnosed and confirmed by PCR at the Institute of Tropical Medicine (ITM) in Antwerp during the recent mpox outbreak May-October 2022, 95 consented patients for follow-up
Smallpox vaccine recipients
sub-group 1: 100 participants routinely vaccinated with two subcutaneous 3rd generation smallpox vaccines sub-group 2: 100 participants routinely vaccinated with two intradermal 3rd generation smallpox vaccines
Healthy controls
50 controls recruited during HIV-PrEP consultation (no former mpox infection, no smallpox vaccination)
Related Therapeutic Areas
Sponsors
Leads: Institute of Tropical Medicine, Belgium

This content was sourced from clinicaltrials.gov