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

NCT06539351 | Completed

• 1 other identifier: 1777/24A
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (1)

• Optimize sample processing for optimal cell yield

  To test the sample processing flow. This involves evaluating the efficiency and practicality of sample collection, preservation, and analysis protocols to ensure optimal cell yield.

  1 day

Secondary Outcomes (2)

• Absolute number of YFC-specific TRM cells per skin biopsy

  1 day

• percentage of YFC-specific TRM cells per skin biopsy

  1day

Study Arms (1)

All participants

OTHER

Other: Skin biopsy

Interventions

Skin biopsy OTHER

4mm skin punch biopsy

All participants

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead

Study Sites (1)

Clinical Trial Site ITM

Antwerp, Belgium

Location

MeSH Terms

Conditions

Yellow Fever

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Study Officials

• Wim Adriaensen, Prof

  Coordinating Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot study to optimize sample processing

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 6, 2024
• Study Start: September 9, 2024
• Primary Completion: November 25, 2024
• Study Completion: November 25, 2024
• Last Updated: May 9, 2025

Record last verified: 2025-05

Locations

BE (1)