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 Type
OBSERVATIONAL
Enrollment
600
Vaccine against SARS-Cov-2 of the Pfizer/BioNTech companies
Any other vaccine authorized and administered by the Greek Ministry of Health against SARS-Cov-2
Department of Clinical Therapeutics, General Hospital of Athens ALEXANDRA
Athens, Greece
RECRUITINGNeutralizing 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
Time frame: Day 50 (28 days after the second dose of the vaccine)
Neutralizing antibodies against SARS-CoV-2
Development of neutralizing antibodies against SARS-CoV-2 on day 1 (before the first dose of the vaccine)
Time frame: Day 1
Neutralizing antibodies against SARS-CoV-2
Development of neutralizing antibodies against SARS-CoV-2 on day 8
Time frame: 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)
Time frame: Day 22
Neutralizing antibodies against SARS-CoV-2
Development of neutralizing antibodies against SARS-CoV-2 on day 36
Time frame: 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
Time frame: 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
Time frame: Month 6
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Neutralizing antibodies against SARS-CoV-2
Development of neutralizing antibodies against SARS-CoV-2 at 9 months post the second dose of the vaccine
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Month 18
Number of memory B-cells against SARS-CoV-2
According to antibody responses on day 1
Time frame: Day 1
Number of memory B-cells against SARS-CoV-2
According to antibody responses on day 8
Time frame: 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)
Time frame: Day 22
Number of memory B-cells against SARS-CoV-2
According to antibody responses on day 36
Time frame: Day 36
Number of memory B-cells against SARS-CoV-2
According to antibody responses on day 50
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Month 18
Number of memory T-cells against SARS-CoV-2
According to antibody responses on day 1
Time frame: Day 1
Number of memory T-cells against SARS-CoV-2
According to antibody responses on day 8
Time frame: 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)
Time frame: Day 22
Number of memory T-cells against SARS-CoV-2
According to antibody responses on day 36
Time frame: Day 36
Number of memory T-cells against SARS-CoV-2
According to antibody responses on day 50
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Month 18
Number of monocytes (CD14+, CD16+)
According to antibody responses on day 1
Time frame: Day 1
Number of monocytes (CD14+, CD16+)
According to antibody responses on day 8
Time frame: Day 8
Number of monocytes (CD14+, CD16+)
According to antibody responses on day 22 (before the second dose of the vaccine)
Time frame: Day 22
Number of monocytes (CD14+, CD16+)
According to antibody responses on day 36
Time frame: Day 36
Number of monocytes (CD14+, CD16+)
According to antibody responses on day 50
Time frame: Day 50
Number of monocytes (CD14+, CD16+)
According to antibody responses at 3 months post the second dose of the vaccine
Time frame: Month 3
Number of monocytes (CD14+, CD16+)
According to antibody responses at 6 months post the second dose of the vaccine
Time frame: Month 6
Number of monocytes (CD14+, CD16+)
According to antibody responses at 9 months post the second dose of the vaccine
Time frame: Month 9
Number of monocytes (CD14+, CD16+)
According to antibody responses at 12 months post the second dose of the vaccine
Time frame: Month 12
Number of monocytes (CD14+, CD16+)
According to antibody responses at 18 months post the second dose of the vaccine
Time frame: 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)
Time frame: Day 1
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Inflammatory cytokines measurements on day 8
Time frame: 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)
Time frame: Day 22
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Inflammatory cytokines measurements on day 23
Time frame: Day 23
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Inflammatory cytokines measurements on day 36
Time frame: Day 36
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Inflammatory cytokines measurements on day 50
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Month 18
TNF-a levels
Inflammatory cytokines measurements on day 1 (before the first dose of the vaccine)
Time frame: Day 1
TNF-a levels
Inflammatory cytokines measurements on day 8
Time frame: Day 8
TNF-a levels
Inflammatory cytokines measurements on day 22 (before the second dose of the vaccine)
Time frame: Day 22
TNF-a levels
Inflammatory cytokines measurements on day 23
Time frame: Day 23
TNF-a levels
Inflammatory cytokines measurements on day 36
Time frame: Day 36
TNF-a levels
Inflammatory cytokines measurements on day 50
Time frame: Day 50
TNF-a levels
Inflammatory cytokines measurements at 3 months post the second dose of the vaccine
Time frame: Month 3
TNF-a levels
Inflammatory cytokines measurements at 6 months post the second dose of the vaccine
Time frame: Month 6
TNF-a levels
Inflammatory cytokines measurements at 9 months post the second dose of the vaccine
Time frame: Month 9
TNF-a levels
Inflammatory cytokines measurements at 12 months post the second dose of the vaccine
Time frame: Month 12
TNF-a levels
Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
Time frame: Month 18
CRP levels
CRP blood level measurements on day 1 (before the first dose of the vaccine)
Time frame: Day 1
CRP levels
CRP blood level measurements on day 8
Time frame: Day 8
CRP levels
CRP blood level measurements on day 22 (before the second dose of the vaccine)
Time frame: Day 22
CRP levels
CRP blood level measurements on day 23
Time frame: Day 23
CRP levels
CRP blood level measurements on day 36
Time frame: Day 36
CRP levels
CRP blood level measurements on day 50
Time frame: Day 50
CRP levels
Inflammatory cytokines measurements at 3 months post the second dose of the vaccine
Time frame: Month 3
CRP levels
Inflammatory cytokines measurements at 6 months post the second dose of the vaccine
Time frame: Month 6
CRP levels
Inflammatory cytokines measurements at 9 months post the second dose of the vaccine
Time frame: Month 9
CRP levels
Inflammatory cytokines measurements at 12 months post the second dose of the vaccine
Time frame: Month 12
CRP levels
Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
Time frame: Month 18