Yellow Fever
Conditions
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.
Interventions
OTHERSkin biopsy
4mm skin punch biopsy
Sponsors
Institute of Tropical Medicine, Belgium
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Pilot study to optimize sample processing
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Optimize sample processing for optimal cell yield | 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
| Measure | Time frame | Description |
|---|---|---|
| Absolute number of YFC-specific TRM cells per skin biopsy | 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. |
| percentage of YFC-specific TRM cells per skin biopsy | 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. |
Countries
Belgium
Outcome results
None listed