- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07636551
Baseline Assessment of Skin Resident Memory T Cells in Healthy Unvaccinated Participants
11 de agosto de 2026 atualizado 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.
Visão geral do estudo
Status
Recrutamento
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Estimado)
40
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Prof. Dr. Patrick Soentjens
- Número de telefone: +3232476641
- E-mail: psoentjens@itg.be
Estude backup de contato
- Nome: Wim Adriaensen
- E-mail: wadriaensen@itg.be
Locais de estudo
-
-
-
Antwerp, Bélgica
- Recrutamento
- Clinical Trial Site of the Institute of Tropical Medicine
-
Contato:
- Yven Van Herrewege
- Número de telefone: +3232476557
- E-mail: yvanherrewege@itg.be
-
Contato:
- Jorge Reis Guerreiro
- E-mail: jreis@itg.be
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Sim
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Outro: 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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
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
Prazo: 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)
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Describe the spatially-resolved position of TRM cells in the skin of unvaccinated and healthy volunteers against YFV
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Day 14 (Visit 2)
|
IgG/IgM levels (mean fluorescence intensity) in capillary blood at visit 2
|
Day 14 (Visit 2)
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
10 de agosto de 2026
Conclusão Primária (Estimado)
15 de novembro de 2026
Conclusão do estudo (Estimado)
15 de novembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
18 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de junho de 2026
Primeira postagem (Real)
9 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
13 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
11 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças transmitidas por vetores
- Doenças transmitidas por mosquitos
- Infecções
- Infecções por vírus de RNA
- Doenças Virais
- Infecções por arbovírus
- Infecções por Flavivírus
- Infecções por Flaviviridae
- Febres Hemorrágicas Virais
- Febre amarela
- Técnicas de investigação
- Manipulação de amostras
- Técnicas de laboratório clínico
- Técnicas e procedimentos de diagnóstico
- Diagnóstico
- Perfurações
- Procedimentos cirúrgicos, operatórios
- Coleção de amostras de sangue
Outros números de identificação do estudo
- 1966/25
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .