- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07636551
Baseline Assessment of Skin Resident Memory T Cells in Healthy Unvaccinated Participants
11 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
40
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Prof. Dr. Patrick Soentjens
- Numéro de téléphone: +3232476641
- E-mail: psoentjens@itg.be
Sauvegarde des contacts de l'étude
- Nom: Wim Adriaensen
- E-mail: wadriaensen@itg.be
Lieux d'étude
-
-
-
Antwerp, Belgique
- Recrutement
- Clinical Trial Site of the Institute of Tropical Medicine
-
Contact:
- Yven Van Herrewege
- Numéro de téléphone: +3232476557
- E-mail: yvanherrewege@itg.be
-
Contact:
- Jorge Reis Guerreiro
- E-mail: jreis@itg.be
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Oui
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
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
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
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
Délai: 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)
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Describe the spatially-resolved position of TRM cells in the skin of unvaccinated and healthy volunteers against YFV
Délai: 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
Délai: 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
Délai: 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
Délai: Day 14 (Visit 2)
|
IgG/IgM levels (mean fluorescence intensity) in capillary blood at visit 2
|
Day 14 (Visit 2)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
10 août 2026
Achèvement primaire (Estimé)
15 novembre 2026
Achèvement de l'étude (Estimé)
15 novembre 2026
Dates d'inscription aux études
Première soumission
18 mai 2026
Première soumission répondant aux critères de contrôle qualité
8 juin 2026
Première publication (Réel)
9 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
13 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies à transmission vectorielle
- Maladies transmises par les moustiques
- Infections
- Infections par virus à ARN
- Maladies virales
- Infections à arbovirus
- Infections à flavivirus
- Infections à Flaviviridae
- Fièvres hémorragiques, virales
- La fièvre jaune
- Techniques d'investigation
- Manipulation des échantillons
- Techniques de laboratoire clinique
- Techniques et procédures de diagnostic
- Diagnostic
- Perforation
- Procédures chirurgicales, opératoires
- Collection d'échantillons de sang
Autres numéros d'identification d'étude
- 1966/25
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .