NCT04743388

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: National and Kapodistrian University of Athens · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-01-04
• Primary completion: 2022-08-01
• Completion: 2022-12-01
• First posted: 2021-02-08
• Last updated: 2022-04-11

Locations

1 site across 1 country: Greece

Regulatory

• FDA-regulated drug study