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Study of the Kinetics of Antibodies Against COVID-19 (SARS-CoV-2) and of Cellular Subpopulations of the Immune System

8. dubna 2022 aktualizováno: 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.

Přehled studie

Detailní popis

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 studie

Pozorovací

Zápis (Očekávaný)

600

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

      • Athens, Řecko
        • Nábor
        • Department of Clinical Therapeutics, General Hospital of Athens ALEXANDRA
        • Kontakt:
          • Evangelos Terpos, MD

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
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

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Neutralizing antibodies against SARS-CoV-2
Časové okno: 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)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Neutralizing antibodies against SARS-CoV-2
Časové okno: 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
Časové okno: Day 8
Development of neutralizing antibodies against SARS-CoV-2 on day 8
Day 8
Neutralizing antibodies against SARS-CoV-2
Časové okno: 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
Časové okno: Day 36
Development of neutralizing antibodies against SARS-CoV-2 on day 36
Day 36
Neutralizing antibodies against SARS-CoV-2
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Day 1
According to antibody responses on day 1
Day 1
Number of memory B-cells against SARS-CoV-2
Časové okno: Day 8
According to antibody responses on day 8
Day 8
Number of memory B-cells against SARS-CoV-2
Časové okno: 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
Časové okno: Day 36
According to antibody responses on day 36
Day 36
Number of memory B-cells against SARS-CoV-2
Časové okno: Day 50
According to antibody responses on day 50
Day 50
Number of memory B-cells against SARS-CoV-2
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Day 1
According to antibody responses on day 1
Day 1
Number of memory T-cells against SARS-CoV-2
Časové okno: Day 8
According to antibody responses on day 8
Day 8
Number of memory T-cells against SARS-CoV-2
Časové okno: 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
Časové okno: Day 36
According to antibody responses on day 36
Day 36
Number of memory T-cells against SARS-CoV-2
Časové okno: Day 50
According to antibody responses on day 50
Day 50
Number of memory T-cells against SARS-CoV-2
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Month 18
According to antibody responses at 18 months post the second dose of the vaccine
Month 18
Number of monocytes (CD14+, CD16+)
Časové okno: Day 1
According to antibody responses on day 1
Day 1
Number of monocytes (CD14+, CD16+)
Časové okno: Day 8
According to antibody responses on day 8
Day 8
Number of monocytes (CD14+, CD16+)
Časové okno: Day 22
According to antibody responses on day 22 (before the second dose of the vaccine)
Day 22
Number of monocytes (CD14+, CD16+)
Časové okno: Day 36
According to antibody responses on day 36
Day 36
Number of monocytes (CD14+, CD16+)
Časové okno: Day 50
According to antibody responses on day 50
Day 50
Number of monocytes (CD14+, CD16+)
Časové okno: Month 3
According to antibody responses at 3 months post the second dose of the vaccine
Month 3
Number of monocytes (CD14+, CD16+)
Časové okno: Month 6
According to antibody responses at 6 months post the second dose of the vaccine
Month 6
Number of monocytes (CD14+, CD16+)
Časové okno: Month 9
According to antibody responses at 9 months post the second dose of the vaccine
Month 9
Number of monocytes (CD14+, CD16+)
Časové okno: Month 12
According to antibody responses at 12 months post the second dose of the vaccine
Month 12
Number of monocytes (CD14+, CD16+)
Časové okno: 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
Časové okno: 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
Časové okno: Day 8
Inflammatory cytokines measurements on day 8
Day 8
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Časové okno: 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
Časové okno: Day 23
Inflammatory cytokines measurements on day 23
Day 23
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Časové okno: Day 36
Inflammatory cytokines measurements on day 36
Day 36
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Časové okno: Day 50
Inflammatory cytokines measurements on day 50
Day 50
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Month 18
Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
Month 18
TNF-a levels
Časové okno: Day 1
Inflammatory cytokines measurements on day 1 (before the first dose of the vaccine)
Day 1
TNF-a levels
Časové okno: Day 8
Inflammatory cytokines measurements on day 8
Day 8
TNF-a levels
Časové okno: Day 22
Inflammatory cytokines measurements on day 22 (before the second dose of the vaccine)
Day 22
TNF-a levels
Časové okno: Day 23
Inflammatory cytokines measurements on day 23
Day 23
TNF-a levels
Časové okno: Day 36
Inflammatory cytokines measurements on day 36
Day 36
TNF-a levels
Časové okno: Day 50
Inflammatory cytokines measurements on day 50
Day 50
TNF-a levels
Časové okno: Month 3
Inflammatory cytokines measurements at 3 months post the second dose of the vaccine
Month 3
TNF-a levels
Časové okno: Month 6
Inflammatory cytokines measurements at 6 months post the second dose of the vaccine
Month 6
TNF-a levels
Časové okno: Month 9
Inflammatory cytokines measurements at 9 months post the second dose of the vaccine
Month 9
TNF-a levels
Časové okno: Month 12
Inflammatory cytokines measurements at 12 months post the second dose of the vaccine
Month 12
TNF-a levels
Časové okno: Month 18
Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
Month 18
CRP levels
Časové okno: Day 1
CRP blood level measurements on day 1 (before the first dose of the vaccine)
Day 1
CRP levels
Časové okno: Day 8
CRP blood level measurements on day 8
Day 8
CRP levels
Časové okno: Day 22
CRP blood level measurements on day 22 (before the second dose of the vaccine)
Day 22
CRP levels
Časové okno: Day 23
CRP blood level measurements on day 23
Day 23
CRP levels
Časové okno: Day 36
CRP blood level measurements on day 36
Day 36
CRP levels
Časové okno: Day 50
CRP blood level measurements on day 50
Day 50
CRP levels
Časové okno: Month 3
Inflammatory cytokines measurements at 3 months post the second dose of the vaccine
Month 3
CRP levels
Časové okno: Month 6
Inflammatory cytokines measurements at 6 months post the second dose of the vaccine
Month 6
CRP levels
Časové okno: Month 9
Inflammatory cytokines measurements at 9 months post the second dose of the vaccine
Month 9
CRP levels
Časové okno: Month 12
Inflammatory cytokines measurements at 12 months post the second dose of the vaccine
Month 12
CRP levels
Časové okno: Month 18
Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
Month 18

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Evangelos Terpos, National and Kapodistrian University of Athens

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

4. ledna 2021

Primární dokončení (Očekávaný)

1. srpna 2022

Dokončení studie (Očekávaný)

1. prosince 2022

Termíny zápisu do studia

První předloženo

3. února 2021

První předloženo, které splnilo kritéria kontroly kvality

5. února 2021

První zveřejněno (Aktuální)

8. února 2021

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

11. dubna 2022

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

8. dubna 2022

Naposledy ověřeno

1. dubna 2022

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

At the end of the study, the results will be announced in medical conferences or medical journals.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na COVID-19

Klinické studie na BNT162b2

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