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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-04

Study Completion Date

2022-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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COVID-19 Healthy Volunteers Chronic Disease Hematological Malignancies Solid Tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

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

BNT162b2

Intervention Type BIOLOGICAL

Vaccine against SARS-Cov-2 of the Pfizer/BioNTech companies

Other vaccine against SARS-Cov-2

Intervention Type BIOLOGICAL

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).

BNT162b2

Intervention Type BIOLOGICAL

Vaccine against SARS-Cov-2 of the Pfizer/BioNTech companies

Other vaccine against SARS-Cov-2

Intervention Type BIOLOGICAL

Any other vaccine authorized and administered by the Greek Ministry of Health against SARS-Cov-2

Interventions

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BNT162b2

Vaccine against SARS-Cov-2 of the Pfizer/BioNTech companies

Intervention Type BIOLOGICAL

Other vaccine against SARS-Cov-2

Any other vaccine authorized and administered by the Greek Ministry of Health against SARS-Cov-2

Intervention Type BIOLOGICAL

Eligibility Criteria

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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