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

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

Detailed Description
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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.

Official Title
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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

Conditions
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COVID-19, Healthy Volunteers, Chronic Disease, Hematological Malignancies, Solid Tumor

Intervention / Treatment
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* Biological: BNT162b2
* Biological: Other vaccine against SARS-Cov-2


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Approximately 300 volunteers, healthy or with chronic diseases (diabetes mellitus, hypertension, heart disease, CRF, etc.) with no autoimmune disorders. | Biological: BNT162b2<br>* Vaccine against SARS-Cov-2 of the Pfizer/BioNTech companies<br>Biological: Other vaccine against SARS-Cov-2<br>* Any other vaccine authorized and administered by the Greek Ministry of Health against SARS-Cov-2<br>|
| Cohort 2<br>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). | Biological: BNT162b2<br>* Vaccine against SARS-Cov-2 of the Pfizer/BioNTech companies<br>Biological: Other vaccine against SARS-Cov-2<br>* Any other vaccine authorized and administered by the Greek Ministry of Health against SARS-Cov-2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neutralizing antibodies against SARS-CoV-2 | 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) | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, BNT162b2 vaccine, Antibodies, SARS-CoV-2