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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 aprile 2022 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Anticipato)

600

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Grecia
      • Athens, Grecia
        • Reclutamento
        • Department of Clinical Therapeutics, General Hospital of Athens ALEXANDRA
        • Contatto:
          • Evangelos Terpos, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Neutralizing antibodies against SARS-CoV-2
Lasso di tempo: 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)

Misure di risultato secondarie

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

National and Kapodistrian University of Athens

Investigatori

  • Investigatore principale: Evangelos Terpos, National and Kapodistrian University of Athens

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

4 gennaio 2021

Completamento primario (Anticipato)

1 agosto 2022

Completamento dello studio (Anticipato)

1 dicembre 2022

Date di iscrizione allo studio

Primo inviato

3 febbraio 2021

Primo inviato che soddisfa i criteri di controllo qualità

5 febbraio 2021

Primo Inserito (Effettivo)

8 febbraio 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 aprile 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 aprile 2022

Ultimo verificato

1 aprile 2022

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 900/24-12-2020

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su COVID-19

Prove cliniche su BNT162b2

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Madagascar

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

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