- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07636551
Baseline Assessment of Skin Resident Memory T Cells in Healthy Unvaccinated Participants
2026년 8월 11일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
40
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Prof. Dr. Patrick Soentjens
- 전화번호: +3232476641
- 이메일: psoentjens@itg.be
연구 연락처 백업
- 이름: Wim Adriaensen
- 이메일: wadriaensen@itg.be
연구 장소
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Antwerp, 벨기에
- 모병
- Clinical Trial Site of the Institute of Tropical Medicine
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연락하다:
- Yven Van Herrewege
- 전화번호: +3232476557
- 이메일: yvanherrewege@itg.be
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연락하다:
- Jorge Reis Guerreiro
- 이메일: jreis@itg.be
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
예
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: Healthy unvaccinated participants against yellow fever virus
Healthy participants that have not been vaccinated against yellow fever virus
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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
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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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
기간: Day 14 (Visit 2)
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The number and proportion of YFV-specific T cells within the skin-resident lymphocyte parent population at visit 2, measured by flow cytometry.
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Day 14 (Visit 2)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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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
기간: Day 0 (Visit 1)
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The number and proportion of circulating YFV-specific TCM and TEM cells within the CD3+ lymphocyte parent population at visit 1
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Day 0 (Visit 1)
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Describe the spatially-resolved position of TRM cells in the skin of unvaccinated and healthy volunteers against YFV
기간: D14 (Visit 2)
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Spatially-resolved YFV-specific TCR clonotypes in the skin at visit 2
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D14 (Visit 2)
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Determine the baseline TCR diversity index in the skin of unvaccinated healthy volunteers against YFV
기간: Day 14 (Visit 2)
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TCR diversity index in the skin at visit 2
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Day 14 (Visit 2)
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Estimate the baseline cytokine and chemokine concentrations in capillary blood, and microbiopsies of unvaccinated and healthy volunteers against YFV
기간: Day 14 (Visit 2)
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The number of cytokine and chemokine concentrations (ng/ul) in capillary blood, and microbiopsies at visit 2
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Day 14 (Visit 2)
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Estimate the baseline YFV-specific IgG/IgM levels in capillary blood of unvaccinated and healthy volunteers
기간: Day 14 (Visit 2)
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IgG/IgM levels (mean fluorescence intensity) in capillary blood at visit 2
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Day 14 (Visit 2)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 8월 10일
기본 완료 (추정된)
2026년 11월 15일
연구 완료 (추정된)
2026년 11월 15일
연구 등록 날짜
최초 제출
2026년 5월 18일
QC 기준을 충족하는 최초 제출
2026년 6월 8일
처음 게시됨 (실제)
2026년 6월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 13일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 11일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 1966/25
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .