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

National and Kapodistrian University of Athens

Status: Unknown

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

Treatments: Biological: BNT162b2; Biological: Other vaccine against SARS-Cov-2

Study type: Observational

Funder types: Other

Identifiers

NCT04743388

900/24-12-2020

Details and patient eligibility

About

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

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

600 participants in 2 patient groups

Cohort 1

Description:

Approximately 300 volunteers, healthy or with chronic diseases (diabetes mellitus, hypertension, heart disease, CRF, etc.) with no autoimmune disorders.

Treatment:

Biological: Other vaccine against SARS-Cov-2

Biological: BNT162b2

Cohort 2

Description:

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).

Treatment:

Biological: Other vaccine against SARS-Cov-2

Biological: BNT162b2