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Baseline Assessment of Skin Resident Memory T Cells in Healthy Unvaccinated Participants

11 agosto 2026 aggiornato da: Institute of Tropical Medicine, Belgium

Baseline Assessment of Skin Resident Memory T Cells in Healthy Unvaccinated Participants (GeKoSkimm-Unvaccinated): add-on Study to the GeKoSkimm Trial (= A Randomized Controlled Trial to Compare the Immunogenicity and Skin Imprinting of Intradermal, Subcutaneous and Intramuscular Yellow Fever Vaccination)

In The main GeKoSkimm trial (= A randomized controlled trial to compare the immunogenicity and skin imprinting of intradermal, subcutaneous and intramuscular yellow fever vaccination) the investigators try to understand whether the route of injection (in the muscle, under the skin, or in the skin) when giving the yellow fever vaccine affects the strength of the body's immune response to yellow fever. More in particular the investigators want to know how well the immune responses are retained in the skin, as this is the place where the virus enters the body after a mosquito bite. This will be important for vaccines against infections transmitted via bites of mosquitoes and ticks, such as yellow fever virus. Because this is the first attempt on human samples and only skin samples after vaccination with yellow fever vaccine are available, the investigators want to assess the baseline or background immune response in 'unvaccinated' skin. Therefore, 40 volunteers will be recruited that have not been previously vaccinated against yellow fever and will not receive a yellow fever vaccine during this study. The participant will be requested to provide two skin samples from the upper arm and a blood sample to confirm their vaccination status regarded to yellow fever.

Panoramica dello studio

Descrizione dettagliata

Since baseline punch biopsies were not preferred nor incorporated in the GeKoSkimm trial (= A randomized controlled trial to compare the immunogenicity and skin imprinting of intradermal, subcutaneous and intramuscular yellow fever vaccination) due to ethical and logistical reasons, studying tissue-resident memory T (TRM) cells in a group of healthy unvaccinated participants is necessary to assess natural baseline levels of TRM cells in the skin before vaccination. The presence TRM cells in healthy and unvaccinated individuals provides a fundamental understanding of normal immune function and biological variability. This baseline data is essential for interpreting responses to vaccination in the GeKoSkimm trial and detecting any deviations or abnormalities that may arise and assess the baseline or background immune response in 'unvaccinated' skin. Therefore, 40 volunteers will be recruited that have not been previously vaccinated against yellow fever and will not receive a yellow fever vaccine during this study. The study consists of two study visits with 14 days (+/- 10 days) between each visit. Blood sampling of 15 mL is performed on the first visit (1X 10 mL Li-Hep + 5 mL SST) to confirm the vaccination status against yellow fever virus (YFV). Participants who turn out positive on the YFV virus neutralization test will be retrospectively excluded from analyses, and replaced with new participants. Skin biopsy sampling (2X 4 mm punch biopsy) in the upper arm is performed only on the second visit, with additional microsampling (microbiopsy and wound blood sampling). The microbiopsy will be taken from 20 participants, followed by two skin punch biopsies from the upper arm from all participants. Subsequently, a blood swab will be collected from the wound blood from all participants.

Tipo di studio

Interventistico

Iscrizione (Stimato)

40

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Prof. Dr. Patrick Soentjens
  • Numero di telefono: +3232476641
  • Email: psoentjens@itg.be

Backup dei contatti dello studio

Luoghi di studio

      • Antwerp, Belgio
        • Reclutamento
        • Clinical Trial Site of the Institute of Tropical Medicine
        • Contatto:
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

Inclusion Criteria:

  • BMI >/=18,5 kg/m2 and ≤35 kg/m2
  • Agreement to share and discuss participant's medical history and medical records when relevant with the study team
  • Able and willing to provide written informed consent
  • Agreement to refrain from blood donation and other vaccinations during the study

Exclusion Criteria:

  • Participants with a confirmed flavivirus infection in the past
  • Participants who received a flavivirus vaccination prior to enrolment (e.g. YFV, Japanese encephalitis virus, tick-borne encephalitis virus, Dengue)
  • Receipt of any vaccine (licensed or experimental) within 30 days prior to enrolment or during the study
  • Active participation in another interventional clinical study with active substance intake or large medical procedures affecting the study procedures during or 1 month prior to enrolment
  • Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature ≥38.0ºC within 24 hours prior to the visit; inclusion at a later date is permitted at the discretion of the investigator
  • Any confirmed or suspected immunosuppressive or immunodeficient state (incl. cancer and human immunodeficiency virus/hepatitis B virus infection); asplenia; recurrent severe infections and use of immunosuppressant medication (including antineoplastic and immunomodulating agents or radiotherapy) within the last 6 months prior to enrolment, except topical or short-term oral steroids (<2 weeks of daily receipt of 20 mg of prednisone or equivalent). Refer to annex 1 for a list of immunosuppressive medication
  • Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, psychiatric and neurological illness (mild/moderate well controlled comorbidities are allowed)
  • History of bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following venipuncture
  • Any significant disease, disorder or planned surgery which may affect the ability of the volunteer to participate in the study or impact (skin) immunity homeostasis
  • Suspected or known alcohol or drug dependency
  • Known pregnancy
  • Tendency to keloid (scar) formation in response to skin damage
  • Skin diseases or tattoo at the biopsy site
  • In the opinion of the investigator, unlikely compliance to the requirements of the study
  • History of thymus dysfunction (including myasthenia gravis, thymoma) or thymectomy
  • Individuals who are working at the investigational site or within the research team of this study
  • Participants who received immunoglobulins and/or any blood or blood derived products within 3 months preceding the study
  • Participants who are currently on anticoagulant therapy
  • Participants who are continuously using systemic antivirals

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: Healthy unvaccinated participants against yellow fever virus
Healthy participants that have not been vaccinated against yellow fever virus
2 x 4mm skin punch biopsies in the upper arm will be taken from each participant at visit 2 with additional microsampling (microbiopsy and wound blood sampling)
Blood sampling of 15 mL (10mL Lithium-Heparine + 5 mL SST) is performed on Visit 1 to confirm their vaccination status regarded to yellow fever

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Estimate the baseline number and proportion of skin-resident memory T cells against YFV (YFV-TRM) in the skin of unvaccinated and healthy volunteers against YFV
Lasso di tempo: Day 14 (Visit 2)
The number and proportion of YFV-specific T cells within the skin-resident lymphocyte parent population at visit 2, measured by flow cytometry.
Day 14 (Visit 2)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Estimate the baseline number and proportion of circulating effector- (YFV-TEM) and central-memory T cells against YFV (YFV-TCM) in the blood of unvaccinated and healthy volunteers against YFV
Lasso di tempo: Day 0 (Visit 1)
The number and proportion of circulating YFV-specific TCM and TEM cells within the CD3+ lymphocyte parent population at visit 1
Day 0 (Visit 1)

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Describe the spatially-resolved position of TRM cells in the skin of unvaccinated and healthy volunteers against YFV
Lasso di tempo: D14 (Visit 2)
Spatially-resolved YFV-specific TCR clonotypes in the skin at visit 2
D14 (Visit 2)
Determine the baseline TCR diversity index in the skin of unvaccinated healthy volunteers against YFV
Lasso di tempo: Day 14 (Visit 2)
TCR diversity index in the skin at visit 2
Day 14 (Visit 2)
Estimate the baseline cytokine and chemokine concentrations in capillary blood, and microbiopsies of unvaccinated and healthy volunteers against YFV
Lasso di tempo: Day 14 (Visit 2)
The number of cytokine and chemokine concentrations (ng/ul) in capillary blood, and microbiopsies at visit 2
Day 14 (Visit 2)
Estimate the baseline YFV-specific IgG/IgM levels in capillary blood of unvaccinated and healthy volunteers
Lasso di tempo: Day 14 (Visit 2)
IgG/IgM levels (mean fluorescence intensity) in capillary blood at visit 2
Day 14 (Visit 2)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

10 agosto 2026

Completamento primario (Stimato)

15 novembre 2026

Completamento dello studio (Stimato)

15 novembre 2026

Date di iscrizione allo studio

Primo inviato

18 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

8 giugno 2026

Primo Inserito (Effettivo)

9 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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