Yellow FeverNCT06539351
A Pilot Study to Finetune Skin Processing Procedures in Recent Vaccinees, Prior to GeKoSkimm Study Initiation (GeKoSkimm-pilot)
A study testing Skin biopsy in people with Yellow Fever, run by Institute of Tropical Medicine, Belgium at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Yellow Fever
- What is being tested?
- Skin biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Sep 2024to 25 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Yellow Fever
- Being tested
- Skin biopsy
- Medical subject headings
- Yellow Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin biopsyOther
4mm skin punch biopsy
| Study group | Role | What they receive |
|---|---|---|
| All participants | Other | Not described Receives: Other: Skin biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (2)
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.
Measured: 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.
Measured: 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start9 Sep 2024
- Primary completion25 Nov 2024
- Study completion25 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Yellow FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study to optimize sample processing
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wim Adriaensen, Prof, Principal investigator, Coordinating Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539351
- Sponsor's protocol ID
- 1777/24A
- Status last verified
- May 2025
- First submitted
- 29 Jul 2024
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Finetune Skin Processing Procedures in Recent Vaccinees, Prior to GeKoSkimm Study Initiation
- ClinicalTrials.gov ID
- NCT06539351
- Acronym / sponsor ID
- 1777/24A
- Conditions
- Yellow Fever
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study to optimize sample processing
| Arm | Type | Receives |
|---|---|---|
| All participants | Other | Other: Skin biopsy |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin biopsy4mm skin punch biopsy | Other | All participants |
Primary outcome
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.
2 secondary outcomes
Absolute number of YFC-specific TRM cells per skin biopsy
Time frame: 1 day
percentage of YFC-specific TRM cells per skin biopsy
Time frame: 1day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
Related trials for Yellow Fever
RecruitingPhase 3
A Phase III Control Study of the Safety and Immunogenicity of vYF in Pediatric Population
Yellow Fever Immunization
RecruitingPhase 4
Antibiotics and Vaccine Immune Responses Study
Vaccine Response Impaired
Active, not recruitingPhase 2
Study on an Investigational Yellow Fever Vaccine Compared With YF-VAX in Adults in the USA
Yellow Fever, Healthy Volunteers
Recruiting
Baseline Assessment of Skin Resident Memory T Cells in Healthy Unvaccinated Participants
Yellow Fever (Healthy Volunteers), Biopsy/Methods
RecruitingPhase 2
Improving Vaccine Protection for Adults
Immune System Responses and Trained Immunity After AS01 Administration, Healthy Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wim Adriaensen, Prof principal investigator
Coordinating Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin biopsy in people with Yellow Fever, run by Institute of Tropical Medicine, Belgium at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimize sample processing for optimal cell yield (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.