NCT06539351

A Pilot Study to Finetune Skin Processing Procedures in Recent Vaccinees, Prior to GeKoSkimm Study Initiation (GeKoSkimm-pilot)

A Pilot Study to Finetune Skin Processing Procedures in Recent Vaccinees, Prior to GeKoSkimm Study Initiation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Institute of Tropical Medicine, Belgium · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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 logistical challenges early, risks will be mitigated and the main study's efficiency will be enhanced. In order to do so, 15 participants will be identified at the ITM polyclinic after receiving a yellow fever vaccination. Participants will be invited to one study visit at the ITM Clinical Trial Site (CTS) 28 days after vaccination to collect blood samples, skin punch biopsies and a minimally-invasive microbiopsy at the site of vaccination. To investigate the ideal location for the skin punch biopsies, participants will be divided in 3 groups; in the first 5 participants the biopsies will be taken directly on the vaccination site, for the next 5 participants, the biopsies will be taken at +/- 3 cm distance from the vaccination site, and for the last five participants, the biopsies will be taken at +/- 10 cm distance from the vaccination site.

Conditions

• Yellow Fever

Interventions

Type	Name	Description
OTHER	Skin biopsy	4mm skin punch biopsy

Timeline

• Start date: 2024-09-09
• Primary completion: 2024-11-25
• Completion: 2024-11-25
• First posted: 2024-08-06
• Last updated: 2025-05-09

Locations

1 site across 1 country: Belgium