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

Overview

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

Full Title of Study: “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”

Study Type

• Study Type: Observational [Patient Registry]
• Study Design
  • Time Perspective: Prospective
• Study Primary Completion Date: August 2022

Detailed Description

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.

Interventions

• Biological: BNT162b2
  • Vaccine against SARS-Cov-2 of the Pfizer/BioNTech companies
• Biological: Other vaccine against SARS-Cov-2
  • Any other vaccine authorized and administered by the Greek Ministry of Health against SARS-Cov-2

Arms, Groups and Cohorts

• Cohort 1
  • Approximately 300 volunteers, healthy or with chronic diseases (diabetes mellitus, hypertension, heart disease, CRF, etc.) with no autoimmune disorders.
• 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).

Clinical Trial Outcome Measures

Primary Measures

• Neutralizing antibodies against SARS-CoV-2
  • Time Frame: 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

Secondary Measures

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

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • National and Kapodistrian University of Athens
• Provider of Information About this Clinical Study
  • Principal Investigator: Prof Evangelos Terpos, Professor of Therapeutics-Hematology – National and Kapodistrian University of Athens
• Overall Official(s)
  • Evangelos Terpos, Principal Investigator, National and Kapodistrian University of Athens
• Overall Contact(s)
  • Ioanna Charitaki, +30 6976156403, j.charitaki@gmail.com