Study of the Kinetics of Antibodies Against COVID-19 (SARS-CoV-2) and of Cellular Subpopulations of the Immune System
8 kwietnia 2022 zaktualizowane przez: 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.
Przegląd badań
Status
Rekrutacyjny
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Obserwacyjny
Zapisy (Oczekiwany)
600
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Ioanna Charitaki
- Numer telefonu: +30 6976156403
- E-mail: j.charitaki@gmail.com
Lokalizacje studiów
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-
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Athens, Grecja
- Rekrutacyjny
- Department of Clinical Therapeutics, General Hospital of Athens ALEXANDRA
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Kontakt:
- Evangelos Terpos, MD
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-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Tak
Płeć kwalifikująca się do nauki
Wszystko
Metoda próbkowania
Próbka bez prawdopodobieństwa
Badana populacja
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.
Opis
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)
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
|
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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Neutralizing antibodies against SARS-CoV-2
Ramy czasowe: 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
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Day 50 (28 days after the second dose of the vaccine)
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Neutralizing antibodies against SARS-CoV-2
Ramy czasowe: Day 1
|
Development of neutralizing antibodies against SARS-CoV-2 on day 1 (before the first dose of the vaccine)
|
Day 1
|
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Neutralizing antibodies against SARS-CoV-2
Ramy czasowe: Day 8
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Development of neutralizing antibodies against SARS-CoV-2 on day 8
|
Day 8
|
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Neutralizing antibodies against SARS-CoV-2
Ramy czasowe: 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
Ramy czasowe: Day 36
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Development of neutralizing antibodies against SARS-CoV-2 on day 36
|
Day 36
|
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Neutralizing antibodies against SARS-CoV-2
Ramy czasowe: 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
Ramy czasowe: Month 6
|
Development of neutralizing 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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Neutralizing antibodies against SARS-CoV-2
Ramy czasowe: 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
Ramy czasowe: Month 12
|
Development of neutralizing antibodies against SARS-CoV-2 at 12 months post the second dose of the vaccine
|
Month 12
|
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Neutralizing antibodies against SARS-CoV-2
Ramy czasowe: Month 18
|
Development of neutralizing antibodies against SARS-CoV-2 at 18 months post the second dose of the vaccine
|
Month 18
|
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Development of anti-S-RBD antibodies against SARS-CoV-2
Ramy czasowe: Day 1
|
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
Ramy czasowe: Day 8
|
Development of anti-S-RBD antibodies against SARS-CoV-2 on day 8
|
Day 8
|
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Development of anti-S-RBD antibodies against SARS-CoV-2
Ramy czasowe: 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)
|
Day 22
|
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Development of anti-S-RBD antibodies against SARS-CoV-2
Ramy czasowe: Day 36
|
Development of anti-S-RBD antibodies against SARS-CoV-2 on day 36
|
Day 36
|
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Development of anti-S-RBD antibodies against SARS-CoV-2
Ramy czasowe: Day 50
|
Development of anti-S-RBD antibodies against SARS-CoV-2 on day 50
|
Day 50
|
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Development of anti-S-RBD antibodies against SARS-CoV-2
Ramy czasowe: Month 3
|
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
Ramy czasowe: 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
|
Month 6
|
|
Development of anti-S-RBD antibodies against SARS-CoV-2
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Day 1
|
According to antibody responses on day 1
|
Day 1
|
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Number of memory B-cells against SARS-CoV-2
Ramy czasowe: Day 8
|
According to antibody responses on day 8
|
Day 8
|
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Number of memory B-cells against SARS-CoV-2
Ramy czasowe: Day 22
|
According to antibody responses on day 22 (before the second dose of the vaccine)
|
Day 22
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Number of memory B-cells against SARS-CoV-2
Ramy czasowe: Day 36
|
According to antibody responses on day 36
|
Day 36
|
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Number of memory B-cells against SARS-CoV-2
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Month 6
|
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
Ramy czasowe: Month 9
|
According to antibody responses at 9 months post the second dose of the vaccine
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Month 9
|
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Number of memory B-cells against SARS-CoV-2
Ramy czasowe: Month 12
|
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
Ramy czasowe: 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
Ramy czasowe: Day 1
|
According to antibody responses on day 1
|
Day 1
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Number of memory T-cells against SARS-CoV-2
Ramy czasowe: Day 8
|
According to antibody responses on day 8
|
Day 8
|
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Number of memory T-cells against SARS-CoV-2
Ramy czasowe: Day 22
|
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 T-cells against SARS-CoV-2
Ramy czasowe: 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
Ramy czasowe: Day 50
|
According to antibody responses on day 50
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Day 50
|
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Number of memory T-cells against SARS-CoV-2
Ramy czasowe: 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 T-cells against SARS-CoV-2
Ramy czasowe: 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 T-cells against SARS-CoV-2
Ramy czasowe: Month 9
|
According to antibody responses at 9 months post the second dose of the vaccine
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Month 9
|
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Number of memory T-cells against SARS-CoV-2
Ramy czasowe: 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 T-cells against SARS-CoV-2
Ramy czasowe: 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 monocytes (CD14+, CD16+)
Ramy czasowe: Day 1
|
According to antibody responses on day 1
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Day 1
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Number of monocytes (CD14+, CD16+)
Ramy czasowe: Day 8
|
According to antibody responses on day 8
|
Day 8
|
|
Number of monocytes (CD14+, CD16+)
Ramy czasowe: Day 22
|
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 monocytes (CD14+, CD16+)
Ramy czasowe: Day 36
|
According to antibody responses on day 36
|
Day 36
|
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Number of monocytes (CD14+, CD16+)
Ramy czasowe: Day 50
|
According to antibody responses on day 50
|
Day 50
|
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Number of monocytes (CD14+, CD16+)
Ramy czasowe: Month 3
|
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 monocytes (CD14+, CD16+)
Ramy czasowe: 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 monocytes (CD14+, CD16+)
Ramy czasowe: Month 9
|
According to antibody responses at 9 months post the second dose of the vaccine
|
Month 9
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Number of monocytes (CD14+, CD16+)
Ramy czasowe: Month 12
|
According to antibody responses at 12 months post the second dose of the vaccine
|
Month 12
|
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Number of monocytes (CD14+, CD16+)
Ramy czasowe: Month 18
|
According to antibody responses at 18 months post the second dose of the vaccine
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Month 18
|
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Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Ramy czasowe: 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
Ramy czasowe: Day 8
|
Inflammatory cytokines measurements on day 8
|
Day 8
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Ramy czasowe: Day 22
|
Inflammatory cytokines measurements on day 22 (before the second dose of the vaccine)
|
Day 22
|
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Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Ramy czasowe: Day 23
|
Inflammatory cytokines measurements on day 23
|
Day 23
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Ramy czasowe: Day 36
|
Inflammatory cytokines measurements on day 36
|
Day 36
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Ramy czasowe: Day 50
|
Inflammatory cytokines measurements on day 50
|
Day 50
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Month 18
|
Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
|
Month 18
|
|
TNF-a levels
Ramy czasowe: Day 1
|
Inflammatory cytokines measurements on day 1 (before the first dose of the vaccine)
|
Day 1
|
|
TNF-a levels
Ramy czasowe: Day 8
|
Inflammatory cytokines measurements on day 8
|
Day 8
|
|
TNF-a levels
Ramy czasowe: Day 22
|
Inflammatory cytokines measurements on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
TNF-a levels
Ramy czasowe: Day 23
|
Inflammatory cytokines measurements on day 23
|
Day 23
|
|
TNF-a levels
Ramy czasowe: Day 36
|
Inflammatory cytokines measurements on day 36
|
Day 36
|
|
TNF-a levels
Ramy czasowe: Day 50
|
Inflammatory cytokines measurements on day 50
|
Day 50
|
|
TNF-a levels
Ramy czasowe: Month 3
|
Inflammatory cytokines measurements at 3 months post the second dose of the vaccine
|
Month 3
|
|
TNF-a levels
Ramy czasowe: Month 6
|
Inflammatory cytokines measurements at 6 months post the second dose of the vaccine
|
Month 6
|
|
TNF-a levels
Ramy czasowe: Month 9
|
Inflammatory cytokines measurements at 9 months post the second dose of the vaccine
|
Month 9
|
|
TNF-a levels
Ramy czasowe: Month 12
|
Inflammatory cytokines measurements at 12 months post the second dose of the vaccine
|
Month 12
|
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TNF-a levels
Ramy czasowe: Month 18
|
Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
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Month 18
|
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CRP levels
Ramy czasowe: Day 1
|
CRP blood level measurements on day 1 (before the first dose of the vaccine)
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Day 1
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CRP levels
Ramy czasowe: Day 8
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CRP blood level measurements on day 8
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Day 8
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CRP levels
Ramy czasowe: Day 22
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CRP blood level measurements on day 22 (before the second dose of the vaccine)
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Day 22
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CRP levels
Ramy czasowe: Day 23
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CRP blood level measurements on day 23
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Day 23
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CRP levels
Ramy czasowe: Day 36
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CRP blood level measurements on day 36
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Day 36
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CRP levels
Ramy czasowe: Day 50
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CRP blood level measurements on day 50
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Day 50
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|
CRP levels
Ramy czasowe: Month 3
|
Inflammatory cytokines measurements at 3 months post the second dose of the vaccine
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Month 3
|
|
CRP levels
Ramy czasowe: Month 6
|
Inflammatory cytokines measurements at 6 months post the second dose of the vaccine
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Month 6
|
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CRP levels
Ramy czasowe: Month 9
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Inflammatory cytokines measurements at 9 months post the second dose of the vaccine
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Month 9
|
|
CRP levels
Ramy czasowe: Month 12
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Inflammatory cytokines measurements at 12 months post the second dose of the vaccine
|
Month 12
|
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CRP levels
Ramy czasowe: Month 18
|
Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
|
Month 18
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Śledczy
- Główny śledczy: Evangelos Terpos, National and Kapodistrian University of Athens
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
4 stycznia 2021
Zakończenie podstawowe (Oczekiwany)
1 sierpnia 2022
Ukończenie studiów (Oczekiwany)
1 grudnia 2022
Daty rejestracji na studia
Pierwszy przesłany
3 lutego 2021
Pierwszy przesłany, który spełnia kryteria kontroli jakości
5 lutego 2021
Pierwszy wysłany (Rzeczywisty)
8 lutego 2021
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
11 kwietnia 2022
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
8 kwietnia 2022
Ostatnia weryfikacja
1 kwietnia 2022
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Procesy patologiczne
- Zakażenia koronawirusem
- Zakażenia Coronaviridae
- Infekcje Nidovirales
- Zakażenia wirusem RNA
- Choroby wirusowe
- Infekcje
- Infekcje dróg oddechowych
- Choroby Układu Oddechowego
- Nowotwory
- Zapalenie płuc, wirusowe
- Zapalenie płuc
- Choroby płuc
- Nowotwory według lokalizacji
- Atrybuty choroby
- Choroby hematologiczne
- COVID-19
- Nowotwory hematologiczne
- Przewlekła choroba
Inne numery identyfikacyjne badania
- 900/24-12-2020
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Opis planu IPD
At the end of the study, the results will be announced in medical conferences or medical journals.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Tak
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
produkt wyprodukowany i wyeksportowany z USA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .