Study of the Kinetics of Antibodies Against COVID-19 (SARS-CoV-2) and of Cellular Subpopulations of the Immune System
2022年4月8日 更新者：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.
調査の概要
状態
募集
詳細な説明
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.
研究の種類
観察的
入学 (予想される)
600
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Ioanna Charitaki
- 電話番号：+30 6976156403
- メール：j.charitaki@gmail.com
研究場所
-
-
-
Athens、ギリシャ
- 募集
- Department of Clinical Therapeutics, General Hospital of Athens ALEXANDRA
-
コンタクト：
- Evangelos Terpos, MD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Cohort 1
Approximately 300 volunteers, healthy or with chronic diseases (diabetes mellitus, hypertension, heart disease, CRF, etc.) with no autoimmune disorders.
|
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
|
|
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).
|
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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Neutralizing antibodies against SARS-CoV-2
時間枠：Day 50 (28 days after the second dose of the vaccine)
|
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
|
Day 50 (28 days after the second dose of the vaccine)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Neutralizing antibodies against SARS-CoV-2
時間枠：Day 1
|
Development of neutralizing antibodies against SARS-CoV-2 on day 1 (before the first dose of the vaccine)
|
Day 1
|
|
Neutralizing antibodies against SARS-CoV-2
時間枠：Day 8
|
Development of neutralizing antibodies against SARS-CoV-2 on day 8
|
Day 8
|
|
Neutralizing antibodies against SARS-CoV-2
時間枠：Day 22
|
Development of neutralizing antibodies against SARS-CoV-2 on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
Neutralizing antibodies against SARS-CoV-2
時間枠：Day 36
|
Development of neutralizing antibodies against SARS-CoV-2 on day 36
|
Day 36
|
|
Neutralizing antibodies against SARS-CoV-2
時間枠：Month 3
|
Development of neutralizing antibodies against SARS-CoV-2 at 3 months post the second dose of the vaccine
|
Month 3
|
|
Neutralizing antibodies against SARS-CoV-2
時間枠：Month 6
|
Development of neutralizing antibodies against SARS-CoV-2 at 6 months post the second dose of the vaccine
|
Month 6
|
|
Neutralizing antibodies against SARS-CoV-2
時間枠：Month 9
|
Development of neutralizing antibodies against SARS-CoV-2 at 9 months post the second dose of the vaccine
|
Month 9
|
|
Neutralizing antibodies against SARS-CoV-2
時間枠：Month 12
|
Development of neutralizing antibodies against SARS-CoV-2 at 12 months post the second dose of the vaccine
|
Month 12
|
|
Neutralizing antibodies against SARS-CoV-2
時間枠：Month 18
|
Development of neutralizing antibodies against SARS-CoV-2 at 18 months post the second dose of the vaccine
|
Month 18
|
|
Development of anti-S-RBD antibodies against SARS-CoV-2
時間枠：Day 1
|
Development of anti-S-RBD antibodies against SARS-CoV-2 on day 1 (before the first dose of the vaccine)
|
Day 1
|
|
Development of anti-S-RBD antibodies against SARS-CoV-2
時間枠：Day 8
|
Development of anti-S-RBD antibodies against SARS-CoV-2 on day 8
|
Day 8
|
|
Development of anti-S-RBD antibodies against SARS-CoV-2
時間枠：Day 22
|
Development of anti-S-RBD antibodies against SARS-CoV-2 on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
Development of anti-S-RBD antibodies against SARS-CoV-2
時間枠：Day 36
|
Development of anti-S-RBD antibodies against SARS-CoV-2 on day 36
|
Day 36
|
|
Development of anti-S-RBD antibodies against SARS-CoV-2
時間枠：Day 50
|
Development of anti-S-RBD antibodies against SARS-CoV-2 on day 50
|
Day 50
|
|
Development of anti-S-RBD antibodies against SARS-CoV-2
時間枠：Month 3
|
Development of anti-S-RBD antibodies against SARS-CoV-2 at 3 months post the second dose of the vaccine
|
Month 3
|
|
Development of anti-S-RBD antibodies against SARS-CoV-2
時間枠：Month 6
|
Development of anti-S-RBD antibodies against SARS-CoV-2 at 6 months post the second dose of the vaccine
|
Month 6
|
|
Development of anti-S-RBD antibodies against SARS-CoV-2
時間枠：Month 9
|
Development of anti-S-RBD antibodies against SARS-CoV-2 at 9 months post the second dose of the vaccine
|
Month 9
|
|
Development of anti-S-RBD antibodies against SARS-CoV-2
時間枠：Month 12
|
Development of anti-S-RBD antibodies against SARS-CoV-2 at 12 months post the second dose of the vaccine
|
Month 12
|
|
Development of anti-S-RBD antibodies against SARS-CoV-2
時間枠：Month 18
|
Development of anti-S-RBD antibodies against SARS-CoV-2 at 18 months post the second dose of the vaccine
|
Month 18
|
|
Number of memory B-cells against SARS-CoV-2
時間枠：Day 1
|
According to antibody responses on day 1
|
Day 1
|
|
Number of memory B-cells against SARS-CoV-2
時間枠：Day 8
|
According to antibody responses on day 8
|
Day 8
|
|
Number of memory B-cells against SARS-CoV-2
時間枠：Day 22
|
According to antibody responses on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
Number of memory B-cells against SARS-CoV-2
時間枠：Day 36
|
According to antibody responses on day 36
|
Day 36
|
|
Number of memory B-cells against SARS-CoV-2
時間枠：Day 50
|
According to antibody responses on day 50
|
Day 50
|
|
Number of memory B-cells against SARS-CoV-2
時間枠：Month 3
|
According to antibody responses at 3 months post the second dose of the vaccine
|
Month 3
|
|
Number of memory B-cells against SARS-CoV-2
時間枠：Month 6
|
According to antibody responses at 6 months post the second dose of the vaccine
|
Month 6
|
|
Number of memory B-cells against SARS-CoV-2
時間枠：Month 9
|
According to antibody responses at 9 months post the second dose of the vaccine
|
Month 9
|
|
Number of memory B-cells against SARS-CoV-2
時間枠：Month 12
|
According to antibody responses at 12 months post the second dose of the vaccine
|
Month 12
|
|
Number of memory B-cells against SARS-CoV-2
時間枠：Month 18
|
According to antibody responses at 18 months post the second dose of the vaccine
|
Month 18
|
|
Number of memory T-cells against SARS-CoV-2
時間枠：Day 1
|
According to antibody responses on day 1
|
Day 1
|
|
Number of memory T-cells against SARS-CoV-2
時間枠：Day 8
|
According to antibody responses on day 8
|
Day 8
|
|
Number of memory T-cells against SARS-CoV-2
時間枠：Day 22
|
According to antibody responses on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
Number of memory T-cells against SARS-CoV-2
時間枠：Day 36
|
According to antibody responses on day 36
|
Day 36
|
|
Number of memory T-cells against SARS-CoV-2
時間枠：Day 50
|
According to antibody responses on day 50
|
Day 50
|
|
Number of memory T-cells against SARS-CoV-2
時間枠：Month 3
|
According to antibody responses at 3 months post the second dose of the vaccine
|
Month 3
|
|
Number of memory T-cells against SARS-CoV-2
時間枠：Month 6
|
According to antibody responses at 6 months post the second dose of the vaccine
|
Month 6
|
|
Number of memory T-cells against SARS-CoV-2
時間枠：Month 9
|
According to antibody responses at 9 months post the second dose of the vaccine
|
Month 9
|
|
Number of memory T-cells against SARS-CoV-2
時間枠：Month 12
|
According to antibody responses at 12 months post the second dose of the vaccine
|
Month 12
|
|
Number of memory T-cells against SARS-CoV-2
時間枠：Month 18
|
According to antibody responses at 18 months post the second dose of the vaccine
|
Month 18
|
|
Number of monocytes (CD14+, CD16+)
時間枠：Day 1
|
According to antibody responses on day 1
|
Day 1
|
|
Number of monocytes (CD14+, CD16+)
時間枠：Day 8
|
According to antibody responses on day 8
|
Day 8
|
|
Number of monocytes (CD14+, CD16+)
時間枠：Day 22
|
According to antibody responses on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
Number of monocytes (CD14+, CD16+)
時間枠：Day 36
|
According to antibody responses on day 36
|
Day 36
|
|
Number of monocytes (CD14+, CD16+)
時間枠：Day 50
|
According to antibody responses on day 50
|
Day 50
|
|
Number of monocytes (CD14+, CD16+)
時間枠：Month 3
|
According to antibody responses at 3 months post the second dose of the vaccine
|
Month 3
|
|
Number of monocytes (CD14+, CD16+)
時間枠：Month 6
|
According to antibody responses at 6 months post the second dose of the vaccine
|
Month 6
|
|
Number of monocytes (CD14+, CD16+)
時間枠：Month 9
|
According to antibody responses at 9 months post the second dose of the vaccine
|
Month 9
|
|
Number of monocytes (CD14+, CD16+)
時間枠：Month 12
|
According to antibody responses at 12 months post the second dose of the vaccine
|
Month 12
|
|
Number of monocytes (CD14+, CD16+)
時間枠：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
時間枠：Day 1
|
Inflammatory cytokines measurements on day 1 (before the first dose of the vaccine)
|
Day 1
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
時間枠：Day 8
|
Inflammatory cytokines measurements on day 8
|
Day 8
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
時間枠：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
時間枠：Day 23
|
Inflammatory cytokines measurements on day 23
|
Day 23
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
時間枠：Day 36
|
Inflammatory cytokines measurements on day 36
|
Day 36
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
時間枠：Day 50
|
Inflammatory cytokines measurements on day 50
|
Day 50
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
時間枠：Month 3
|
Inflammatory cytokines measurements at 3 months post the second dose of the vaccine
|
Month 3
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
時間枠：Month 6
|
Inflammatory cytokines measurements at 6 months post the second dose of the vaccine
|
Month 6
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
時間枠：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
時間枠：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
時間枠：Month 18
|
Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
|
Month 18
|
|
TNF-a levels
時間枠：Day 1
|
Inflammatory cytokines measurements on day 1 (before the first dose of the vaccine)
|
Day 1
|
|
TNF-a levels
時間枠：Day 8
|
Inflammatory cytokines measurements on day 8
|
Day 8
|
|
TNF-a levels
時間枠：Day 22
|
Inflammatory cytokines measurements on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
TNF-a levels
時間枠：Day 23
|
Inflammatory cytokines measurements on day 23
|
Day 23
|
|
TNF-a levels
時間枠：Day 36
|
Inflammatory cytokines measurements on day 36
|
Day 36
|
|
TNF-a levels
時間枠：Day 50
|
Inflammatory cytokines measurements on day 50
|
Day 50
|
|
TNF-a levels
時間枠：Month 3
|
Inflammatory cytokines measurements at 3 months post the second dose of the vaccine
|
Month 3
|
|
TNF-a levels
時間枠：Month 6
|
Inflammatory cytokines measurements at 6 months post the second dose of the vaccine
|
Month 6
|
|
TNF-a levels
時間枠：Month 9
|
Inflammatory cytokines measurements at 9 months post the second dose of the vaccine
|
Month 9
|
|
TNF-a levels
時間枠：Month 12
|
Inflammatory cytokines measurements at 12 months post the second dose of the vaccine
|
Month 12
|
|
TNF-a levels
時間枠：Month 18
|
Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
|
Month 18
|
|
CRP levels
時間枠：Day 1
|
CRP blood level measurements on day 1 (before the first dose of the vaccine)
|
Day 1
|
|
CRP levels
時間枠：Day 8
|
CRP blood level measurements on day 8
|
Day 8
|
|
CRP levels
時間枠：Day 22
|
CRP blood level measurements on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
CRP levels
時間枠：Day 23
|
CRP blood level measurements on day 23
|
Day 23
|
|
CRP levels
時間枠：Day 36
|
CRP blood level measurements on day 36
|
Day 36
|
|
CRP levels
時間枠：Day 50
|
CRP blood level measurements on day 50
|
Day 50
|
|
CRP levels
時間枠：Month 3
|
Inflammatory cytokines measurements at 3 months post the second dose of the vaccine
|
Month 3
|
|
CRP levels
時間枠：Month 6
|
Inflammatory cytokines measurements at 6 months post the second dose of the vaccine
|
Month 6
|
|
CRP levels
時間枠：Month 9
|
Inflammatory cytokines measurements at 9 months post the second dose of the vaccine
|
Month 9
|
|
CRP levels
時間枠：Month 12
|
Inflammatory cytokines measurements at 12 months post the second dose of the vaccine
|
Month 12
|
|
CRP levels
時間枠：Month 18
|
Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
|
Month 18
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Evangelos Terpos、National and Kapodistrian University of Athens
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2021年1月4日
一次修了 (予想される)
2022年8月1日
研究の完了 (予想される)
2022年12月1日
試験登録日
最初に提出
2021年2月3日
QC基準を満たした最初の提出物
2021年2月5日
最初の投稿 (実際)
2021年2月8日
学習記録の更新
投稿された最後の更新 (実際)
2022年4月11日
QC基準を満たした最後の更新が送信されました
2022年4月8日
最終確認日
2022年4月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 900/24-12-2020
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
At the end of the study, the results will be announced in medical conferences or medical journals.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。