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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04743388
Enrollment
600
Registered
2021-02-08
Start date
2021-01-04
Completion date
2022-12-31
Last updated
2022-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

COVID-19, BNT162b2 vaccine, Antibodies, SARS-CoV-2

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.

Interventions

BIOLOGICALBNT162b2

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

BIOLOGICALOther vaccine against SARS-Cov-2

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

Sponsors

National and Kapodistrian University of Athens
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Neutralizing antibodies against SARS-CoV-2Day 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

MeasureTime frameDescription
Development of anti-S-RBD antibodies against SARS-CoV-2Day 1Development of anti-S-RBD antibodies against SARS-CoV-2 on day 1 (before the first dose of the vaccine)
Number of memory B-cells against SARS-CoV-2Day 1According to antibody responses on day 1
Number of memory T-cells against SARS-CoV-2Day 1According to antibody responses on day 1
Neutralizing antibodies against SARS-CoV-2Day 1Development of neutralizing antibodies against SARS-CoV-2 on day 1 (before the first dose of the vaccine)
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levelsDay 1Inflammatory cytokines measurements on day 1 (before the first dose of the vaccine)
TNF-a levelsDay 1Inflammatory cytokines measurements on day 1 (before the first dose of the vaccine)
CRP levelsDay 1CRP blood level measurements on day 1 (before the first dose of the vaccine)
Number of monocytes (CD14+, CD16+)Day 1According to antibody responses on day 1

Countries

Greece

Contacts

Primary ContactIoanna Charitaki
j.charitaki@gmail.com+30 6976156403

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026