Study of the Kinetics of Antibodies Against COVID-19 (SARS-CoV-2) and of Cellular Subpopulations of the Immune System
2022년 4월 8일 업데이트: Prof Evangelos Terpos, National and Kapodistrian University of Athens
Study of the Kinetics of Antibodies Against SARS-CoV-2 and of Cellular Subpopulations of the Immune System in Volunteers Receiving the BNT162b2 Vaccine or Other Approved Vaccine Against SARS-CoV-2
Determination of both the degree and duration of the immunity provided after receiving the BNT162b2 vaccine against SARS-Cov-2.
연구 개요
상태
모병
상세 설명
The purpose of this study is to assess the kinetics of antibodies against SARS-CoV-2 as well as the kinetics of the immune system's cell subpopulations and cytokines associated with the immune system in healthy volunteers receiving the BNT162b2 vaccine against SARS-Cov-2 of the Pfizer/BioNTech companies or any other vaccine authorized and administered by the Ministry of Health.
Immunoassays will be performed at serum collection points before and after vaccination, as set out in this study.
연구 유형
관찰
등록 (예상)
600
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Ioanna Charitaki
- 전화번호: +30 6976156403
- 이메일: j.charitaki@gmail.com
연구 장소
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Athens, 그리스
- 모병
- Department of Clinical Therapeutics, General Hospital of Athens ALEXANDRA
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연락하다:
- Evangelos Terpos, MD
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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
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
The admission criteria include both healthy volunteers and all individuals who, according to the instructions of the Greek State are considered eligible to receive the BNT162b2 vaccine.
In particular, the study includes people with hematological malignancies or solid tumors, either receiving treatment or in remission/ follow-up, pursuant to the vaccination instructions of the Ministry of Health.
The study will also include patients with autoimmune diseases who receive or do not receive treatment for their disease.
Patients with diabetes mellitus, hypertension, heart disease, chronic renal failure of all stages (and undergoing dialysis) or other chronic diseases deemed suitable for vaccination, according to the instructions of the Ministry of Health, may also participate in the study.
설명
Inclusion Criteria:
- Healthy volunteers and all individuals who, according to the instructions of the Greek State are considered eligible to receive the BNT162b2 vaccine
- Age ≥ 18 years old
Exclusion Criteria:
- Serious allergy problems i.e. hospitalization due to a serious allergic reaction (anaphylaxis)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Cohort 1
Approximately 300 volunteers, healthy or with chronic diseases (diabetes mellitus, hypertension, heart disease, CRF, etc.) with no autoimmune disorders.
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Vaccine against SARS-Cov-2 of the Pfizer/BioNTech companies
Any other vaccine authorized and administered by the Greek Ministry of Health against SARS-Cov-2
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Cohort 2
People with hematological malignancies or solid tumors in various phases of their treatment (under treatment or in remission/ follow-up).
This cohort may include patients with smoldering multiple myeloma (n=50), multiple myeloma (n=140), chronic lymphocytic leukemia (with or without hypoglobulinemia) (n=50), lymphoma (n=80), AL amyloidosis (n=30), patients who receive PARP (n=30), CDK4/6 (n=30), or immune checkpoint inhibitors (n=40), and patients under therapy with Androgen Receptor Targeted Agents (n=50).
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Vaccine against SARS-Cov-2 of the Pfizer/BioNTech companies
Any other vaccine authorized and administered by the Greek Ministry of Health against SARS-Cov-2
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Neutralizing antibodies against SARS-CoV-2
기간: Day 50 (28 days after the second dose of the vaccine)
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Primary endpoint of the study is the development of neutralizing antibodies against SARS-CoV-2 on Day 50 28 days after the second dose of the vaccine) in the study populations
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Day 50 (28 days after the second dose of the vaccine)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Neutralizing antibodies against SARS-CoV-2
기간: Day 1
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Development of neutralizing antibodies against SARS-CoV-2 on day 1 (before the first dose of the vaccine)
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Day 1
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Neutralizing antibodies against SARS-CoV-2
기간: Day 8
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Development of neutralizing antibodies against SARS-CoV-2 on day 8
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Day 8
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Neutralizing antibodies against SARS-CoV-2
기간: Day 22
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Development of neutralizing antibodies against SARS-CoV-2 on day 22 (before the second dose of the vaccine)
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Day 22
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Neutralizing antibodies against SARS-CoV-2
기간: Day 36
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Development of neutralizing antibodies against SARS-CoV-2 on day 36
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Day 36
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Neutralizing antibodies against SARS-CoV-2
기간: Month 3
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Development of neutralizing antibodies against SARS-CoV-2 at 3 months post the second dose of the vaccine
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Month 3
|
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Neutralizing antibodies against SARS-CoV-2
기간: Month 6
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Development of neutralizing antibodies against SARS-CoV-2 at 6 months post the second dose of the vaccine
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Month 6
|
|
Neutralizing antibodies against SARS-CoV-2
기간: Month 9
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Development of neutralizing antibodies against SARS-CoV-2 at 9 months post the second dose of the vaccine
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Month 9
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Neutralizing antibodies against SARS-CoV-2
기간: Month 12
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Development of neutralizing antibodies against SARS-CoV-2 at 12 months post the second dose of the vaccine
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Month 12
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Neutralizing antibodies against SARS-CoV-2
기간: Month 18
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Development of neutralizing antibodies against SARS-CoV-2 at 18 months post the second dose of the vaccine
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Month 18
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Development of anti-S-RBD antibodies against SARS-CoV-2
기간: Day 1
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Development of anti-S-RBD antibodies against SARS-CoV-2 on day 1 (before the first dose of the vaccine)
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Day 1
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Development of anti-S-RBD antibodies against SARS-CoV-2
기간: Day 8
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Development of anti-S-RBD antibodies against SARS-CoV-2 on day 8
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Day 8
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Development of anti-S-RBD antibodies against SARS-CoV-2
기간: Day 22
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Development of anti-S-RBD antibodies against SARS-CoV-2 on day 22 (before the second dose of the vaccine)
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Day 22
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Development of anti-S-RBD antibodies against SARS-CoV-2
기간: Day 36
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Development of anti-S-RBD antibodies against SARS-CoV-2 on day 36
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Day 36
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Development of anti-S-RBD antibodies against SARS-CoV-2
기간: Day 50
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Development of anti-S-RBD antibodies against SARS-CoV-2 on day 50
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Day 50
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Development of anti-S-RBD antibodies against SARS-CoV-2
기간: Month 3
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Development of anti-S-RBD antibodies against SARS-CoV-2 at 3 months post the second dose of the vaccine
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Month 3
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Development of anti-S-RBD antibodies against SARS-CoV-2
기간: Month 6
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Development of anti-S-RBD antibodies against SARS-CoV-2 at 6 months post the second dose of the vaccine
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Month 6
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Development of anti-S-RBD antibodies against SARS-CoV-2
기간: Month 9
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Development of anti-S-RBD antibodies against SARS-CoV-2 at 9 months post the second dose of the vaccine
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Month 9
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Development of anti-S-RBD antibodies against SARS-CoV-2
기간: Month 12
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Development of anti-S-RBD antibodies against SARS-CoV-2 at 12 months post the second dose of the vaccine
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Month 12
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Development of anti-S-RBD antibodies against SARS-CoV-2
기간: Month 18
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Development of anti-S-RBD antibodies against SARS-CoV-2 at 18 months post the second dose of the vaccine
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Month 18
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Number of memory B-cells against SARS-CoV-2
기간: Day 1
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According to antibody responses on day 1
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Day 1
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Number of memory B-cells against SARS-CoV-2
기간: Day 8
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According to antibody responses on day 8
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Day 8
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Number of memory B-cells against SARS-CoV-2
기간: Day 22
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According to antibody responses on day 22 (before the second dose of the vaccine)
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Day 22
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Number of memory B-cells against SARS-CoV-2
기간: Day 36
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According to antibody responses on day 36
|
Day 36
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Number of memory B-cells against SARS-CoV-2
기간: Day 50
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According to antibody responses on day 50
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Day 50
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Number of memory B-cells against SARS-CoV-2
기간: Month 3
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According to antibody responses at 3 months post the second dose of the vaccine
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Month 3
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Number of memory B-cells against SARS-CoV-2
기간: Month 6
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According to antibody responses at 6 months post the second dose of the vaccine
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Month 6
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Number of memory B-cells against SARS-CoV-2
기간: Month 9
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According to antibody responses at 9 months post the second dose of the vaccine
|
Month 9
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Number of memory B-cells against SARS-CoV-2
기간: Month 12
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According to antibody responses at 12 months post the second dose of the vaccine
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Month 12
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Number of memory B-cells against SARS-CoV-2
기간: Month 18
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According to antibody responses at 18 months post the second dose of the vaccine
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Month 18
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Number of memory T-cells against SARS-CoV-2
기간: Day 1
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According to antibody responses on day 1
|
Day 1
|
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Number of memory T-cells against SARS-CoV-2
기간: Day 8
|
According to antibody responses on day 8
|
Day 8
|
|
Number of memory T-cells against SARS-CoV-2
기간: Day 22
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According to antibody responses on day 22 (before the second dose of the vaccine)
|
Day 22
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Number of memory T-cells against SARS-CoV-2
기간: Day 36
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According to antibody responses on day 36
|
Day 36
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Number of memory T-cells against SARS-CoV-2
기간: Day 50
|
According to antibody responses on day 50
|
Day 50
|
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Number of memory T-cells against SARS-CoV-2
기간: Month 3
|
According to antibody responses at 3 months post the second dose of the vaccine
|
Month 3
|
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Number of memory T-cells against SARS-CoV-2
기간: Month 6
|
According to antibody responses at 6 months post the second dose of the vaccine
|
Month 6
|
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Number of memory T-cells against SARS-CoV-2
기간: Month 9
|
According to antibody responses at 9 months post the second dose of the vaccine
|
Month 9
|
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Number of memory T-cells against SARS-CoV-2
기간: Month 12
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According to antibody responses at 12 months post the second dose of the vaccine
|
Month 12
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Number of memory T-cells against SARS-CoV-2
기간: Month 18
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According to antibody responses at 18 months post the second dose of the vaccine
|
Month 18
|
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Number of monocytes (CD14+, CD16+)
기간: Day 1
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According to antibody responses on day 1
|
Day 1
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Number of monocytes (CD14+, CD16+)
기간: Day 8
|
According to antibody responses on day 8
|
Day 8
|
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Number of monocytes (CD14+, CD16+)
기간: Day 22
|
According to antibody responses on day 22 (before the second dose of the vaccine)
|
Day 22
|
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Number of monocytes (CD14+, CD16+)
기간: Day 36
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According to antibody responses on day 36
|
Day 36
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Number of monocytes (CD14+, CD16+)
기간: Day 50
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According to antibody responses on day 50
|
Day 50
|
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Number of monocytes (CD14+, CD16+)
기간: Month 3
|
According to antibody responses at 3 months post the second dose of the vaccine
|
Month 3
|
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Number of monocytes (CD14+, CD16+)
기간: Month 6
|
According to antibody responses at 6 months post the second dose of the vaccine
|
Month 6
|
|
Number of monocytes (CD14+, CD16+)
기간: Month 9
|
According to antibody responses at 9 months post the second dose of the vaccine
|
Month 9
|
|
Number of monocytes (CD14+, CD16+)
기간: Month 12
|
According to antibody responses at 12 months post the second dose of the vaccine
|
Month 12
|
|
Number of monocytes (CD14+, CD16+)
기간: Month 18
|
According to antibody responses at 18 months post the second dose of the vaccine
|
Month 18
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
기간: Day 1
|
Inflammatory cytokines measurements on day 1 (before the first dose of the vaccine)
|
Day 1
|
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Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
기간: Day 8
|
Inflammatory cytokines measurements on day 8
|
Day 8
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
기간: Day 22
|
Inflammatory cytokines measurements on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
기간: Day 23
|
Inflammatory cytokines measurements on day 23
|
Day 23
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
기간: Day 36
|
Inflammatory cytokines measurements on day 36
|
Day 36
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
기간: Day 50
|
Inflammatory cytokines measurements on day 50
|
Day 50
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
기간: Month 3
|
Inflammatory cytokines measurements at 3 months post the second dose of the vaccine
|
Month 3
|
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Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
기간: Month 6
|
Inflammatory cytokines measurements at 6 months post the second dose of the vaccine
|
Month 6
|
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Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
기간: Month 9
|
Inflammatory cytokines measurements at 9 months post the second dose of the vaccine
|
Month 9
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
기간: Month 12
|
Inflammatory cytokines measurements at 12 months post the second dose of the vaccine
|
Month 12
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
기간: Month 18
|
Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
|
Month 18
|
|
TNF-a levels
기간: Day 1
|
Inflammatory cytokines measurements on day 1 (before the first dose of the vaccine)
|
Day 1
|
|
TNF-a levels
기간: Day 8
|
Inflammatory cytokines measurements on day 8
|
Day 8
|
|
TNF-a levels
기간: Day 22
|
Inflammatory cytokines measurements on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
TNF-a levels
기간: Day 23
|
Inflammatory cytokines measurements on day 23
|
Day 23
|
|
TNF-a levels
기간: Day 36
|
Inflammatory cytokines measurements on day 36
|
Day 36
|
|
TNF-a levels
기간: Day 50
|
Inflammatory cytokines measurements on day 50
|
Day 50
|
|
TNF-a levels
기간: Month 3
|
Inflammatory cytokines measurements at 3 months post the second dose of the vaccine
|
Month 3
|
|
TNF-a levels
기간: Month 6
|
Inflammatory cytokines measurements at 6 months post the second dose of the vaccine
|
Month 6
|
|
TNF-a levels
기간: Month 9
|
Inflammatory cytokines measurements at 9 months post the second dose of the vaccine
|
Month 9
|
|
TNF-a levels
기간: Month 12
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Inflammatory cytokines measurements at 12 months post the second dose of the vaccine
|
Month 12
|
|
TNF-a levels
기간: Month 18
|
Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
|
Month 18
|
|
CRP levels
기간: Day 1
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CRP blood level measurements on day 1 (before the first dose of the vaccine)
|
Day 1
|
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CRP levels
기간: Day 8
|
CRP blood level measurements on day 8
|
Day 8
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|
CRP levels
기간: Day 22
|
CRP blood level measurements on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
CRP levels
기간: Day 23
|
CRP blood level measurements on day 23
|
Day 23
|
|
CRP levels
기간: Day 36
|
CRP blood level measurements on day 36
|
Day 36
|
|
CRP levels
기간: Day 50
|
CRP blood level measurements on day 50
|
Day 50
|
|
CRP levels
기간: Month 3
|
Inflammatory cytokines measurements at 3 months post the second dose of the vaccine
|
Month 3
|
|
CRP levels
기간: Month 6
|
Inflammatory cytokines measurements at 6 months post the second dose of the vaccine
|
Month 6
|
|
CRP levels
기간: Month 9
|
Inflammatory cytokines measurements at 9 months post the second dose of the vaccine
|
Month 9
|
|
CRP levels
기간: Month 12
|
Inflammatory cytokines measurements at 12 months post the second dose of the vaccine
|
Month 12
|
|
CRP levels
기간: Month 18
|
Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
|
Month 18
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Evangelos Terpos, National and Kapodistrian University of Athens
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Dagla I, Iliou A, Benaki D, Gikas E, Mikros E, Bagratuni T, Kastritis E, Dimopoulos MA, Terpos E, Tsarbopoulos A. Plasma Metabolomic Alterations Induced by COVID-19 Vaccination Reveal Putative Biomarkers Reflecting the Immune Response. Cells. 2022 Apr 6;11(7):1241. doi: 10.3390/cells11071241.
- Gavriatopoulou M, Terpos E, Ntanasis-Stathopoulos I, Briasoulis A, Gumeni S, Malandrakis P, Fotiou D, Migkou M, Theodorakakou F, Eleutherakis-Papaiakovou E, Kanellias N, Kastritis E, Trougakos IP, Dimopoulos MA. Poor neutralizing antibody responses in 106 patients with WM after vaccination against SARS-CoV-2: a prospective study. Blood Adv. 2021 Nov 9;5(21):4398-4405. doi: 10.1182/bloodadvances.2021005444.
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)
2021년 1월 4일
기본 완료 (예상)
2022년 8월 1일
연구 완료 (예상)
2022년 12월 1일
연구 등록 날짜
최초 제출
2021년 2월 3일
QC 기준을 충족하는 최초 제출
2021년 2월 5일
처음 게시됨 (실제)
2021년 2월 8일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 4월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 4월 8일
마지막으로 확인됨
2022년 4월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 900/24-12-2020
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
At the end of the study, the results will be announced in medical conferences or medical journals.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
미국에서 제조되어 미국에서 수출되는 제품
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. .
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Endourage, LLC모병긴 COVID | 긴 Covid19 | 포스트 급성 COVID-19 | 장거리 COVID | 장거리 COVID-19 | COVID-19 후 증후군미국
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Massachusetts General Hospital모병
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University Hospital, Ioannina1st Division of Internal Medicine, University Hospital of Ioannina모병COVID-19 폐렴 | COVID-19 호흡기 감염 | 코로나19 감염병 세계적 유행 | COVID-19 급성호흡곤란증후군 | COVID-19 관련 폐렴 | COVID 19 관련 응고병증 | COVID-19(코로나바이러스 질병 2019) | COVID-19 관련 혈전색전증그리스
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University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention...완전한
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Jonathann Kuo, MD모집하지 않고 적극적으로SARS-CoV2 감염 | 코로나19 이후 증후군 | 자율신경실조증 | 급성 COVID-19 후 증후군 | 긴 COVID | 긴 Covid19 | COVID-19 재발 | 포스트 급성 COVID-19 | 급성 COVID-19 감염 후 | COVID-19의 급성 후유증 | 자율신경실조증 유사 장애 | 자율신경실조증 기립성 저혈압 증후군 | COVID-19 이후 상태 | 포스트 코로나 증후군 | COVID-19 이후 상태, 지정되지 않음미국
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Patrick Robinson모병코로나19 | COVID-19 폐렴 | COVID-19 호흡기 감염 | COVID-19 급성 기관지염미국
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Janssen Vaccines & Prevention B.V.완전한
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Daewoong Pharmaceutical Co. LTD.Novotech (Australia) Pty Limited알려지지 않은COVID-19 환자
BNT162b2에 대한 임상 시험
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BioNTech SE완전한코로나바이러스감염증-19 : 코로나19 | SARS-CoV2 감염 | SARS-CoV-2 급성 호흡기 질환 | 사스(질병)미국, 독일, 칠면조, 남아프리카
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BioNTech SEPfizer완전한코로나바이러스감염증-19 : 코로나19 | SARS-CoV-2 감염미국, 브라질, 남아프리카, 독일, 캐나다, 이스라엘
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BioNTech SEPfizer완전한코로나바이러스감염증-19 : 코로나19 | SARS-CoV-2 감염미국
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BioNTech SEPfizer완전한SARS-CoV-2 감염, COVID-19미국, 스페인, 핀란드, 폴란드, 멕시코, 브라질
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Universiteit Antwerpen완전한
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The University of Hong Kong모병
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Murdoch Childrens Research InstituteCoalition for Epidemic Preparedness Innovations; The Peter Doherty Institute for Infection...빼는
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BioNTech SEPfizer모병코로나바이러스감염증-19 : 코로나19 | 중증급성호흡기증후군 코로나바이러스 2 | SARS-CoV-2 바이러스미국, 브라질, 푸에르토 리코