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

April 8, 2022 updated by: Prof Evangelos Terpos, National and Kapodistrian University of Athens

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Greece
      • Athens, Greece
        • Recruiting
        • Department of Clinical Therapeutics, General Hospital of Athens ALEXANDRA
        • Contact:
          • Evangelos Terpos, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The admission criteria include both healthy volunteers and all individuals who, according to the instructions of the Greek State are considered eligible to receive the BNT162b2 vaccine. In particular, the study includes people with hematological malignancies or solid tumors, either receiving treatment or in remission/ follow-up, pursuant to the vaccination instructions of the Ministry of Health. The study will also include patients with autoimmune diseases who receive or do not receive treatment for their disease. Patients with diabetes mellitus, hypertension, heart disease, chronic renal failure of all stages (and undergoing dialysis) or other chronic diseases deemed suitable for vaccination, according to the instructions of the Ministry of Health, may also participate in the study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Cohort 1
Approximately 300 volunteers, healthy or with chronic diseases (diabetes mellitus, hypertension, heart disease, CRF, etc.) with no autoimmune disorders.
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
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).
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Neutralizing antibodies against SARS-CoV-2
Time Frame: 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
Day 50 (28 days after the second dose of the vaccine)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Neutralizing antibodies against SARS-CoV-2
Time Frame: Day 1
Development of neutralizing antibodies against SARS-CoV-2 on day 1 (before the first dose of the vaccine)
Day 1
Neutralizing antibodies against SARS-CoV-2
Time Frame: Day 8
Development of neutralizing antibodies against SARS-CoV-2 on day 8
Day 8
Neutralizing antibodies against SARS-CoV-2
Time Frame: Day 22
Development of neutralizing antibodies against SARS-CoV-2 on day 22 (before the second dose of the vaccine)
Day 22
Neutralizing antibodies against SARS-CoV-2
Time Frame: Day 36
Development of neutralizing antibodies against SARS-CoV-2 on day 36
Day 36
Neutralizing antibodies against SARS-CoV-2
Time Frame: Month 3
Development of neutralizing antibodies against SARS-CoV-2 at 3 months post the second dose of the vaccine
Month 3
Neutralizing antibodies against SARS-CoV-2
Time Frame: Month 6
Development of neutralizing antibodies against SARS-CoV-2 at 6 months post the second dose of the vaccine
Month 6
Neutralizing antibodies against SARS-CoV-2
Time Frame: Month 9
Development of neutralizing antibodies against SARS-CoV-2 at 9 months post the second dose of the vaccine
Month 9
Neutralizing antibodies against SARS-CoV-2
Time Frame: Month 12
Development of neutralizing antibodies against SARS-CoV-2 at 12 months post the second dose of the vaccine
Month 12
Neutralizing antibodies against SARS-CoV-2
Time Frame: Month 18
Development of neutralizing antibodies against SARS-CoV-2 at 18 months post the second dose of the vaccine
Month 18
Development of anti-S-RBD antibodies against SARS-CoV-2
Time Frame: Day 1
Development of anti-S-RBD antibodies against SARS-CoV-2 on day 1 (before the first dose of the vaccine)
Day 1
Development of anti-S-RBD antibodies against SARS-CoV-2
Time Frame: Day 8
Development of anti-S-RBD antibodies against SARS-CoV-2 on day 8
Day 8
Development of anti-S-RBD antibodies against SARS-CoV-2
Time Frame: Day 22
Development of anti-S-RBD antibodies against SARS-CoV-2 on day 22 (before the second dose of the vaccine)
Day 22
Development of anti-S-RBD antibodies against SARS-CoV-2
Time Frame: Day 36
Development of anti-S-RBD antibodies against SARS-CoV-2 on day 36
Day 36
Development of anti-S-RBD antibodies against SARS-CoV-2
Time Frame: Day 50
Development of anti-S-RBD antibodies against SARS-CoV-2 on day 50
Day 50
Development of anti-S-RBD antibodies against SARS-CoV-2
Time Frame: Month 3
Development of anti-S-RBD antibodies against SARS-CoV-2 at 3 months post the second dose of the vaccine
Month 3
Development of anti-S-RBD antibodies against SARS-CoV-2
Time Frame: Month 6
Development of anti-S-RBD antibodies against SARS-CoV-2 at 6 months post the second dose of the vaccine
Month 6
Development of anti-S-RBD antibodies against SARS-CoV-2
Time Frame: Month 9
Development of anti-S-RBD antibodies against SARS-CoV-2 at 9 months post the second dose of the vaccine
Month 9
Development of anti-S-RBD antibodies against SARS-CoV-2
Time Frame: Month 12
Development of anti-S-RBD antibodies against SARS-CoV-2 at 12 months post the second dose of the vaccine
Month 12
Development of anti-S-RBD antibodies against SARS-CoV-2
Time Frame: Month 18
Development of anti-S-RBD antibodies against SARS-CoV-2 at 18 months post the second dose of the vaccine
Month 18
Number of memory B-cells against SARS-CoV-2
Time Frame: Day 1
According to antibody responses on day 1
Day 1
Number of memory B-cells against SARS-CoV-2
Time Frame: Day 8
According to antibody responses on day 8
Day 8
Number of memory B-cells against SARS-CoV-2
Time Frame: Day 22
According to antibody responses on day 22 (before the second dose of the vaccine)
Day 22
Number of memory B-cells against SARS-CoV-2
Time Frame: Day 36
According to antibody responses on day 36
Day 36
Number of memory B-cells against SARS-CoV-2
Time Frame: Day 50
According to antibody responses on day 50
Day 50
Number of memory B-cells against SARS-CoV-2
Time Frame: Month 3
According to antibody responses at 3 months post the second dose of the vaccine
Month 3
Number of memory B-cells against SARS-CoV-2
Time Frame: Month 6
According to antibody responses at 6 months post the second dose of the vaccine
Month 6
Number of memory B-cells against SARS-CoV-2
Time Frame: Month 9
According to antibody responses at 9 months post the second dose of the vaccine
Month 9
Number of memory B-cells against SARS-CoV-2
Time Frame: Month 12
According to antibody responses at 12 months post the second dose of the vaccine
Month 12
Number of memory B-cells against SARS-CoV-2
Time Frame: Month 18
According to antibody responses at 18 months post the second dose of the vaccine
Month 18
Number of memory T-cells against SARS-CoV-2
Time Frame: Day 1
According to antibody responses on day 1
Day 1
Number of memory T-cells against SARS-CoV-2
Time Frame: Day 8
According to antibody responses on day 8
Day 8
Number of memory T-cells against SARS-CoV-2
Time Frame: Day 22
According to antibody responses on day 22 (before the second dose of the vaccine)
Day 22
Number of memory T-cells against SARS-CoV-2
Time Frame: Day 36
According to antibody responses on day 36
Day 36
Number of memory T-cells against SARS-CoV-2
Time Frame: Day 50
According to antibody responses on day 50
Day 50
Number of memory T-cells against SARS-CoV-2
Time Frame: Month 3
According to antibody responses at 3 months post the second dose of the vaccine
Month 3
Number of memory T-cells against SARS-CoV-2
Time Frame: Month 6
According to antibody responses at 6 months post the second dose of the vaccine
Month 6
Number of memory T-cells against SARS-CoV-2
Time Frame: Month 9
According to antibody responses at 9 months post the second dose of the vaccine
Month 9
Number of memory T-cells against SARS-CoV-2
Time Frame: Month 12
According to antibody responses at 12 months post the second dose of the vaccine
Month 12
Number of memory T-cells against SARS-CoV-2
Time Frame: Month 18
According to antibody responses at 18 months post the second dose of the vaccine
Month 18
Number of monocytes (CD14+, CD16+)
Time Frame: Day 1
According to antibody responses on day 1
Day 1
Number of monocytes (CD14+, CD16+)
Time Frame: Day 8
According to antibody responses on day 8
Day 8
Number of monocytes (CD14+, CD16+)
Time Frame: Day 22
According to antibody responses on day 22 (before the second dose of the vaccine)
Day 22
Number of monocytes (CD14+, CD16+)
Time Frame: Day 36
According to antibody responses on day 36
Day 36
Number of monocytes (CD14+, CD16+)
Time Frame: Day 50
According to antibody responses on day 50
Day 50
Number of monocytes (CD14+, CD16+)
Time Frame: Month 3
According to antibody responses at 3 months post the second dose of the vaccine
Month 3
Number of monocytes (CD14+, CD16+)
Time Frame: Month 6
According to antibody responses at 6 months post the second dose of the vaccine
Month 6
Number of monocytes (CD14+, CD16+)
Time Frame: Month 9
According to antibody responses at 9 months post the second dose of the vaccine
Month 9
Number of monocytes (CD14+, CD16+)
Time Frame: Month 12
According to antibody responses at 12 months post the second dose of the vaccine
Month 12
Number of monocytes (CD14+, CD16+)
Time Frame: Month 18
According to antibody responses at 18 months post the second dose of the vaccine
Month 18
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Time Frame: Day 1
Inflammatory cytokines measurements on day 1 (before the first dose of the vaccine)
Day 1
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Time Frame: Day 8
Inflammatory cytokines measurements on day 8
Day 8
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Time Frame: Day 22
Inflammatory cytokines measurements on day 22 (before the second dose of the vaccine)
Day 22
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Time Frame: Day 23
Inflammatory cytokines measurements on day 23
Day 23
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Time Frame: Day 36
Inflammatory cytokines measurements on day 36
Day 36
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Time Frame: Day 50
Inflammatory cytokines measurements on day 50
Day 50
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Time Frame: Month 3
Inflammatory cytokines measurements at 3 months post the second dose of the vaccine
Month 3
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Time Frame: Month 6
Inflammatory cytokines measurements at 6 months post the second dose of the vaccine
Month 6
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Time Frame: Month 9
Inflammatory cytokines measurements at 9 months post the second dose of the vaccine
Month 9
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Time Frame: Month 12
Inflammatory cytokines measurements at 12 months post the second dose of the vaccine
Month 12
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Time Frame: Month 18
Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
Month 18
TNF-a levels
Time Frame: Day 1
Inflammatory cytokines measurements on day 1 (before the first dose of the vaccine)
Day 1
TNF-a levels
Time Frame: Day 8
Inflammatory cytokines measurements on day 8
Day 8
TNF-a levels
Time Frame: Day 22
Inflammatory cytokines measurements on day 22 (before the second dose of the vaccine)
Day 22
TNF-a levels
Time Frame: Day 23
Inflammatory cytokines measurements on day 23
Day 23
TNF-a levels
Time Frame: Day 36
Inflammatory cytokines measurements on day 36
Day 36
TNF-a levels
Time Frame: Day 50
Inflammatory cytokines measurements on day 50
Day 50
TNF-a levels
Time Frame: Month 3
Inflammatory cytokines measurements at 3 months post the second dose of the vaccine
Month 3
TNF-a levels
Time Frame: Month 6
Inflammatory cytokines measurements at 6 months post the second dose of the vaccine
Month 6
TNF-a levels
Time Frame: Month 9
Inflammatory cytokines measurements at 9 months post the second dose of the vaccine
Month 9
TNF-a levels
Time Frame: Month 12
Inflammatory cytokines measurements at 12 months post the second dose of the vaccine
Month 12
TNF-a levels
Time Frame: Month 18
Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
Month 18
CRP levels
Time Frame: Day 1
CRP blood level measurements on day 1 (before the first dose of the vaccine)
Day 1
CRP levels
Time Frame: Day 8
CRP blood level measurements on day 8
Day 8
CRP levels
Time Frame: Day 22
CRP blood level measurements on day 22 (before the second dose of the vaccine)
Day 22
CRP levels
Time Frame: Day 23
CRP blood level measurements on day 23
Day 23
CRP levels
Time Frame: Day 36
CRP blood level measurements on day 36
Day 36
CRP levels
Time Frame: Day 50
CRP blood level measurements on day 50
Day 50
CRP levels
Time Frame: Month 3
Inflammatory cytokines measurements at 3 months post the second dose of the vaccine
Month 3
CRP levels
Time Frame: Month 6
Inflammatory cytokines measurements at 6 months post the second dose of the vaccine
Month 6
CRP levels
Time Frame: Month 9
Inflammatory cytokines measurements at 9 months post the second dose of the vaccine
Month 9
CRP levels
Time Frame: Month 12
Inflammatory cytokines measurements at 12 months post the second dose of the vaccine
Month 12
CRP levels
Time Frame: Month 18
Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
Month 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National and Kapodistrian University of Athens

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Evangelos Terpos, National and Kapodistrian University of Athens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 4, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 900/24-12-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

At the end of the study, the results will be announced in medical conferences or medical journals.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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