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

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

Study Overview

• Status: Recruiting
• Conditions: COVID-19; Chronic Disease; Solid Tumor; Healthy Volunteers; Hematological Malignancies
• Intervention / Treatment: Biological: BNT162b2; Biological: Other vaccine against SARS-Cov-2

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.

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Ioanna Charitaki; Phone Number: +30 6976156403; Email: j.charitaki@gmail.com

Study Locations

• Greece
  • Athens, Greece
    • Recruiting
    • Department of Clinical Therapeutics, General Hospital of Athens ALEXANDRA
    • Contact: Evangelos Terpos, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The admission criteria include both healthy volunteers and all individuals who, according to the instructions of the Greek State are considered eligible to receive the BNT162b2 vaccine. In particular, the study includes people with hematological malignancies or solid tumors, either receiving treatment or in remission/ follow-up, pursuant to the vaccination instructions of the Ministry of Health. The study will also include patients with autoimmune diseases who receive or do not receive treatment for their disease. Patients with diabetes mellitus, hypertension, heart disease, chronic renal failure of all stages (and undergoing dialysis) or other chronic diseases deemed suitable for vaccination, according to the instructions of the Ministry of Health, may also participate in the study.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National and Kapodistrian University of Athens
• Investigators: Principal Investigator: Evangelos Terpos, National and Kapodistrian University of Athens

Publications and helpful links

General Publications

• Dagla I, Iliou A, Benaki D, Gikas E, Mikros E, Bagratuni T, Kastritis E, Dimopoulos MA, Terpos E, Tsarbopoulos A. Plasma Metabolomic Alterations Induced by COVID-19 Vaccination Reveal Putative Biomarkers Reflecting the Immune Response. Cells. 2022 Apr 6;11(7):1241. doi: 10.3390/cells11071241.
• Gavriatopoulou M, Terpos E, Ntanasis-Stathopoulos I, Briasoulis A, Gumeni S, Malandrakis P, Fotiou D, Migkou M, Theodorakakou F, Eleutherakis-Papaiakovou E, Kanellias N, Kastritis E, Trougakos IP, Dimopoulos MA. Poor neutralizing antibody responses in 106 patients with WM after vaccination against SARS-CoV-2: a prospective study. Blood Adv. 2021 Nov 9;5(21):4398-4405. doi: 10.1182/bloodadvances.2021005444.

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: February 3, 2021
• First Submitted That Met QC Criteria: February 5, 2021
• First Posted (Actual): February 8, 2021

Study Record Updates

• Last Update Posted (Actual): April 11, 2022
• Last Update Submitted That Met QC Criteria: April 8, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID-19; Antibodies; BNT162b2 vaccine
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Neoplasms; Pneumonia, Viral; Pneumonia; Lung Diseases; Neoplasms by Site; Disease Attributes; Hematologic Diseases; COVID-19; Hematologic Neoplasms; Chronic Disease
• Other Study ID Numbers: 900/24-12-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: At the end of the study, the results will be announced in medical conferences or medical journals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No