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

• Conditions: Hematological Malignancies; Solid Tumor; COVID-19; Healthy Volunteers; Chronic Disease
• Interventions: Biological: BNT162b2; Biological: Other vaccine against SARS-Cov-2

• Registration Number: NCT04743388
• Lead Sponsor: National and Kapodistrian University of Athens

Brief Summary

Determination of both the degree and duration of the immunity provided after receiving the BNT162b2 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 Timeline

• Study Start: 2021-01-04
• Study First Submitted: 2021-02-03
• Study First Submitted QC: 2021-02-05
• Study First Posted: 2021-02-08
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-08
• Last Update Posted: 2022-04-11
• Primary Completion: 2022-08
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	BNT162b2	Approximately 300 volunteers, healthy or with chronic diseases (diabetes mellitus, hypertension, heart disease, CRF, etc.) with no autoimmune disorders.
Cohort 2	BNT162b2	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).
Cohort 1	Other vaccine against SARS-Cov-2	Approximately 300 volunteers, healthy or with chronic diseases (diabetes mellitus, hypertension, heart disease, CRF, etc.) with no autoimmune disorders.
Cohort 2	Other vaccine against SARS-Cov-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).

Primary Outcome Measures

Name	Time	Method
Neutralizing antibodies against SARS-CoV-2	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 Outcome Measures

Name	Time	Method
Number of memory B-cells against SARS-CoV-2	Month 18	According to antibody responses at 18 months post the second dose of the vaccine
Neutralizing antibodies against SARS-CoV-2	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	Month 18	Development of anti-S-RBD antibodies against SARS-CoV-2 at 18 months post the second dose of the vaccine
Number of monocytes (CD14+, CD16+)	Month 18	According to antibody responses at 18 months post the second dose of the vaccine
CRP levels	Month 18	Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
Number of memory T-cells against SARS-CoV-2	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	Month 18	Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
TNF-a levels	Month 18	Inflammatory cytokines measurements at 18 months post the second dose of the vaccine

Trial Locations

Locations (1)

Department of Clinical Therapeutics, General Hospital of Athens ALEXANDRA; 🇬🇷 Athens, Greece