Status:
COMPLETED
A Pilot Study to Finetune Skin Processing Procedures in Recent Vaccinees, Prior to GeKoSkimm Study Initiation (GeKoSkimm-pilot)
Lead Sponsor:
Institute of Tropical Medicine, Belgium
Conditions:
Yellow Fever
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
This pilot study aims to optimize the sample processing techniques for collecting and analyzing skin biopsies obtained from individuals routinely vaccinated against yellow fever. By addressing logisti...
Eligibility Criteria
Inclusion
- BMI lower than 30kg/m²
- Able and willing to provide written informed consent
- Having received a yellow fever vaccination 28 days (+2 or -2 days) ago
Exclusion
- Any confirmed or suspected immunosuppressive or immunodeficient state (incl. cancer); asplenia; recurrent severe infections and use of immunosuppressant medication within the last 6 months prior to recruitment, except topical or short-term oral steroids
- History of bleeding disorder (e.g., factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following venipuncture
- Any other significant disease, disorder, planned surgery, or finding which may significantly affect the ability of the volunteer to participate in the study
- Tendency to keloid (scar) formation in response to skin damage
- Skin diseases at the biopsy or vaccination site
Key Trial Info
Start Date :
September 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 25 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06539351
Start Date
September 9 2024
End Date
November 25 2024
Last Update
May 9 2025
Active Locations (1)
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1
Clinical Trial Site ITM
Antwerp, Belgium