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

11 de agosto de 2026 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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 de estudio

Intervencionista

Inscripción (Estimado)

40

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Prof. Dr. Patrick Soentjens
  • Número de teléfono: +3232476641
  • Correo electrónico: psoentjens@itg.be

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

      • Antwerp, Bélgica
        • Reclutamiento
        • Clinical Trial Site of the Institute of Tropical Medicine
        • Contacto:
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

Sí

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Otro
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: 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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
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
Periodo de tiempo: 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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
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
Periodo de tiempo: 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)

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Describe the spatially-resolved position of TRM cells in the skin of unvaccinated and healthy volunteers against YFV
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Day 14 (Visit 2)
IgG/IgM levels (mean fluorescence intensity) in capillary blood at visit 2
Day 14 (Visit 2)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

10 de agosto de 2026

Finalización primaria (Estimado)

15 de noviembre de 2026

Finalización del estudio (Estimado)

15 de noviembre de 2026

Fechas de registro del estudio

Enviado por primera vez

18 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

8 de junio de 2026

Publicado por primera vez (Actual)

9 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

11 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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