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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. April 2022 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Voraussichtlich)

600

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Griechenland
      • Athens, Griechenland
        • Rekrutierung
        • Department of Clinical Therapeutics, General Hospital of Athens ALEXANDRA
        • Kontakt:
          • Evangelos Terpos, MD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Cohort 1
Approximately 300 volunteers, healthy or with chronic diseases (diabetes mellitus, hypertension, heart disease, CRF, etc.) with no autoimmune disorders.
Biologisch: BNT162b2
Vaccine against SARS-Cov-2 of the Pfizer/BioNTech companies
Biologisch: Other vaccine against SARS-Cov-2
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).
Biologisch: BNT162b2
Vaccine against SARS-Cov-2 of the Pfizer/BioNTech companies
Biologisch: Other vaccine against SARS-Cov-2
Any other vaccine authorized and administered by the Greek Ministry of Health against SARS-Cov-2

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Neutralizing antibodies against SARS-CoV-2
Zeitfenster: 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)

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

National and Kapodistrian University of Athens

Ermittler

  • Hauptermittler: Evangelos Terpos, National and Kapodistrian University of Athens

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

4. Januar 2021

Primärer Abschluss (Voraussichtlich)

1. August 2022

Studienabschluss (Voraussichtlich)

1. Dezember 2022

Studienanmeldedaten

Zuerst eingereicht

3. Februar 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. Februar 2021

Zuerst gepostet (Tatsächlich)

8. Februar 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. April 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. April 2022

Zuletzt verifiziert

1. April 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 900/24-12-2020

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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