Prospective Study for the FOLLOW-UP of Human Monkeypox Cases and Smallpox Vaccinees at Risk
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Monkeypox. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
Long-term problems or sequelae after an acute viral infection are described. The study aim is to investigate if long-term symptoms and sequelae can be found in the ITM human mpox infection cohort previously diagnosed and confirmed by PCR at the Institute of Tropical Medicine in Antwerp during the mpox outbreak 2022 in Belgium. The immune response after a natural mpox infection and after a smallpox vaccination will additionally analysed over time.
Consented participants Mpox patients, acute infection (n=169, 21% assumed smallpox vaccination in childhood) Mpox patients for follow-up (n=95, 20% assumed smallpox vaccination in childhood) Smallpox vaccinees, two intradermal doses (n=100) Smallpox vaccinees, two subcutaneous doses (n=100) Healthy unvaccinated controls (n=50)
Design This prospective longitudinal study has the main objectives 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. Participants are being followed up 8, 16 and 24 months after infection or vaccination.
Sample collection Anal eSwabs from patients, controls and vaccinees Saliva (Omnigene-oral and dry swabs) from patients, controls and vaccinees Serum from patients, controls and vaccinees Optional semen samples from patients PBMC samples from a sub-group of patients, controls and vaccinees
Laboratory analysis MPXV-PCR on saliva, anorectal and optional semen samples of former mpox patients, vaccinated individuals and healthy controls Mpox-specific antibody profiling from serum Mucosal immunity (IgA, IgG) mpox-specific/reactive from anal swabs and/or saliva Enumeration of MPXV-specific effector-memory T cells via flow cytometry-based AIM or ICS assays (peptide pool stimulation or HLA-restricted multimer-based capture assays) Enumeration of MPXV-specific memory B cells or plasma cells via flow cytometry-ased AIM or ICS assays (recombinant antigen stimulation or HLA-restricted multimer-based capture assays)
Primary outcome measures
- Proportion of individuals with a positive mpox serology in both groups [Time frame: 2 years]
- Proportion of long-term problems or sequelae in mpox patients [Time frame: 2 years]
Secondary outcome measures (1)
- longevity of humoral and/or cellular immune response to mpox or vaccinia virus [Time frame: 2 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Belgium · 1 center
- Institute of Tropical Medicine — Antwerp
Identifiers
NCT: NCT05879965 · 1628/22