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NCT Number: NCT06539351

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

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.

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Trial Site ITM

Antwerp, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Skin biopsy

Other

4mm skin punch biopsy

Primary outcomes

  1. Optimize sample processing for optimal cell yield

    Time frame: 1 day

    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.

Secondary outcomes

  1. Absolute number of YFC-specific TRM cells per skin biopsy

    Time frame: 1 day

    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.

  2. percentage of YFC-specific TRM cells per skin biopsy

    Time frame: 1day

    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.

Sponsors and collaborators

Lead sponsor

Institute of Tropical Medicine, Belgium

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 6, 2024
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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