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

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.

Study Overview

• Status: Completed
• Conditions: Yellow Fever
• Intervention / Treatment: Other: Skin biopsy

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium
    • Clinical Trial Site ITM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: All participants	Other: Skin biopsy; 4mm skin punch biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute number of YFC-specific TRM cells per skin biopsy	Using different skin dissociation protocols, the absolute number of YFV-specific TRM cells that can be isolated out of 4mm punch biopsy skin samples, as determined by flow cytometry.	1 day
percentage of YFC-specific TRM cells per skin biopsy	Using different skin dissociation protocols, the percentage of YFV-specific TRM cells that can be isolated out of 4mm punch biopsy skin samples, as determined by flow cytometry.	1day

Collaborators and Investigators

• Sponsor: Institute of Tropical Medicine, Belgium
• Investigators: Principal Investigator: Wim Adriaensen, Prof, Coordinating Investigator

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2024
• Primary Completion (Actual): November 25, 2024
• Study Completion (Actual): November 25, 2024

Study Registration Dates

• First Submitted: July 29, 2024
• First Submitted That Met QC Criteria: August 1, 2024
• First Posted (Actual): August 6, 2024

Study Record Updates

• Last Update Posted (Actual): May 9, 2025
• Last Update Submitted That Met QC Criteria: May 8, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vector Borne Diseases; Mosquito-Borne Diseases; Infections; RNA Virus Infections; Virus Diseases; Arbovirus Infections; Flavivirus Infections; Flaviviridae Infections; Hemorrhagic Fevers, Viral; Yellow Fever
• Other Study ID Numbers: 1777/24A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No