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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04743388
• Other study ID #: 900/24-12-2020
• Status: Recruiting
• Start date: January 4, 2021
• Est. completion date: December 2022

Study information

• Verified date: April 2022
• Source: National and Kapodistrian University of Athens
• Contact: Ioanna Charitaki
• Phone: +30 6976156403
• Email: j.charitaki[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Disease
• COVID-19
• Healthy Volunteers
• Hematologic Neoplasms
• Hematological Malignancies
• Solid Tumor

Intervention

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

Locations

Country	Name	City	State
Greece	Department of Clinical Therapeutics, General Hospital of Athens ALEXANDRA	Athens

Sponsors (1)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

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