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Approximately 300 volunteers, healthy or with chronic diseases (diabetes mellitus, hypertension, heart disease, CRF, etc.) with no autoimmune disorders.

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

BNT162b2

Any other vaccine authorized and administered by the Greek Ministry of Health against SARS-Cov-2

Other vaccine against SARS-Cov-2

Ioanna Charitaki

Evangelos Terpos, MD

Evangelos Terpos

Determination of both the degree and duration of the immunity provided after receiving the BNT162b2 vaccine against SARS-Cov-2.

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.

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

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

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

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

Development of neutralizing antibodies against SARS-CoV-2 on day 1 (before the first dose of the vaccine)

Development of neutralizing antibodies against SARS-CoV-2 on day 8

Development of neutralizing antibodies against SARS-CoV-2 on day 22 (before the second dose of the vaccine)

Development of neutralizing antibodies against SARS-CoV-2 on day 36

Development of neutralizing antibodies against SARS-CoV-2 at 3 months post the second dose of the vaccine

Development of neutralizing antibodies against SARS-CoV-2 at 6 months post the second dose of the vaccine

Development of neutralizing antibodies against SARS-CoV-2 at 9 months post the second dose of the vaccine

Development of neutralizing antibodies against SARS-CoV-2 at 12 months post the second dose of the vaccine

Development of neutralizing antibodies against SARS-CoV-2 at 18 months post the second dose of the vaccine

Development of anti-S-RBD antibodies against SARS-CoV-2 on day 1 (before the first dose of the vaccine)

Development of anti-S-RBD antibodies against SARS-CoV-2 on day 8

Development of anti-S-RBD antibodies against SARS-CoV-2 on day 22 (before the second dose of the vaccine)

Development of anti-S-RBD antibodies against SARS-CoV-2 on day 36

Development of anti-S-RBD antibodies against SARS-CoV-2 on day 50

Development of anti-S-RBD antibodies against SARS-CoV-2 at 3 months post the second dose of the vaccine

Development of anti-S-RBD antibodies against SARS-CoV-2 at 6 months post the second dose of the vaccine

Development of anti-S-RBD antibodies against SARS-CoV-2 at 9 months post the second dose of the vaccine

Development of anti-S-RBD antibodies against SARS-CoV-2 at 12 months post the second dose of the vaccine

Development of anti-S-RBD antibodies against SARS-CoV-2 at 18 months post the second dose of the vaccine

According to antibody responses on day 22 (before the second dose of the vaccine)

According to antibody responses on day 36

According to antibody responses on day 50

According to antibody responses at 3 months post the second dose of the vaccine

According to antibody responses at 6 months post the second dose of the vaccine

According to antibody responses at 9 months post the second dose of the vaccine

According to antibody responses at 12 months post the second dose of the vaccine

According to antibody responses at 18 months post the second dose of the vaccine

Inflammatory cytokines measurements on day 1 (before the first dose of the vaccine)

Inflammatory cytokines measurements on day 8

Inflammatory cytokines measurements on day 22 (before the second dose of the vaccine)

Inflammatory cytokines measurements on day 23

Inflammatory cytokines measurements on day 36

Inflammatory cytokines measurements on day 50

Inflammatory cytokines measurements at 3 months post the second dose of the vaccine

Inflammatory cytokines measurements at 6 months post the second dose of the vaccine

Inflammatory cytokines measurements at 9 months post the second dose of the vaccine

Inflammatory cytokines measurements at 12 months post the second dose of the vaccine

Inflammatory cytokines measurements at 18 months post the second dose of the vaccine

CRP blood level measurements on day 1 (before the first dose of the vaccine)

CRP blood level measurements on day 22 (before the second dose of the vaccine)

Spots Global Cancer Trial Database for Study of the Kinetics of Antibodies Against COVID-19 (SARS-CoV-2) and of Cellular Subpopulations of the Immune System

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