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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 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

600

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Grækenland
      • Athens, Grækenland
        • Rekruttering
        • Department of Clinical Therapeutics, General Hospital of Athens ALEXANDRA
        • Kontakt:
          • Evangelos Terpos, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Neutralizing antibodies against SARS-CoV-2
Tidsramme: 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)

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National and Kapodistrian University of Athens

Efterforskere

  • Ledende efterforsker: Evangelos Terpos, National and Kapodistrian University of Athens

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

4. januar 2021

Primær færdiggørelse (Forventet)

1. august 2022

Studieafslutning (Forventet)

1. december 2022

Datoer for studieregistrering

Først indsendt

3. februar 2021

Først indsendt, der opfyldte QC-kriterier

5. februar 2021

Først opslået (Faktiske)

8. februar 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. april 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. april 2022

Sidst verificeret

1. april 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 900/24-12-2020

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med COVID-19

Kliniske forsøg med BNT162b2

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Japan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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