Comparative Evaluation of Covid-19 Vaccines Response

July 11, 2021 updated by: Prof.Dr.Taha Bekci, Karamanoğlu Mehmetbey University

Comparative Evaluation of Covid-19 Vaccines Response and Progression in Different Covid-19 Vaccines Groups

Study Population

Population with vaccinated with three different Covid Vaccines (Inactive Vaccine (Sinovac Life Sciences, Beijing, China), recombinant human adenovirus serotype number 26 (rAd26 of Sputnik V), mRNA Vaccine (Pfizer/BionTEC). This is multi center study, 5 centers will be joined to study from different part of the country. Approximately 1500 people will be enrolled to study.

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

Aim of Study

  • to evaluate Anti-SARS-CoV-2 IgG Antibody and Neutralizing Antibody response in different Vaccine Groups
  • to evaluate progression of the vaccine response after 2, 6, and 12 Months after Vaccination in different Vaccine Groups, and compare antibody response in different Vaccines Group.
  • It was also aimed to evaluate effect of the age, gender, co-morbid conditions such as COPD, DM, Heart Failure, Covid Infection on IgG Antibody and Neutralizing Antibody response.

Anti SARS CoV2 IgG antibody levels will be measured with chemiluminescence method (CHEM) by using ADVIA Centaur XP Immunassay System (Siemens Helthcare, GmbH, Germany) and Anti SARS CoV2 IgG reactive (Siemens Helthineers, GmbH, Germany).

Neutralizing Capacity of Anti-SARS-CoV-2 Antibodies against SARS CoV2 levels will be determined with ELISA method (ELx 808, ELISA Microplate Absorbance Reader, BioTek Instruments Inc, Winooski, VT, USA) by using Euroimmun SARS-CoV-2 NeutraLISA Assay (EUROIMMUN, Medizinische Labordiagnostika AG, Germany).

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.
1500

Contacts and Locations

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

Study Locations

  • Turkey
      • Karaman, Turkey, 70200
        • Recruiting
        • Karamanoglu Mehmetbey University
        • Contact:
      • Konya, Turkey, 42250
        • Recruiting
        • Selcuk University
        • Contact:
      • Tekirdağ, Turkey
        • Not yet recruiting
        • Tekirdag Namık Kemal University, Faculty of Medicine
        • Contact:
      • Trabzon, Turkey
        • Not yet recruiting
        • Karadeniz Technic University, Faculty of Medicine
        • Contact:

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 to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

- Any person, male or female, over 18 years of age.

Description

Inclusion Criteria:

- Any person, male or female, over 18 years of age.

  1. The patient has signed an informed consent form.
  2. The patient was vaccinated with SARS-CoV-2 vaccine.

Exclusion Criteria:

  • Inability to give clear information (person in an emergency, difficulty understanding the subject, etc.)
  • Person under safeguard of justice
  • Person under guardianship or curator ship.

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

  • Observational Models: Case-Crossover
  • Time Perspectives: Prospective

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.
Group, vaccinated with Inactive Vaccine (Sinovac Life Sciences, Beijing, China).
- Any person, male or female, over 18 years of age, were vaccinated with Inactive Vaccine.
Biological: Covid-19 Inactive Vaccine, recombinant human adenovirus serotype number 26, mRNA VAccine
Anti-SARS-CoV-2 IgG Antibody and Neutralizing Antibody will be evaluated 2, 6, 12 Months after second dose.
Group, vaccinated with recombinant human adenovirus serotype number 26 (rAd26 of Sputnik V).
- Any person, male or female, over 18 years of age, were vaccinated with recombinant human adenovirus serotype number 26.
Biological: Covid-19 Inactive Vaccine, recombinant human adenovirus serotype number 26, mRNA VAccine
Anti-SARS-CoV-2 IgG Antibody and Neutralizing Antibody will be evaluated 2, 6, 12 Months after second dose.
Group, vaccinated with mRNA Vaccine (Pfizer/BionTEC).
- Any person, male or female, over 18 years of age, were vaccinated with mRNA Vaccine.
Biological: Covid-19 Inactive Vaccine, recombinant human adenovirus serotype number 26, mRNA VAccine
Anti-SARS-CoV-2 IgG Antibody and Neutralizing Antibody will be evaluated 2, 6, 12 Months after second dose.

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
Change from baseline in Anti-SARS-CoV-2 IgG Antibody and Neutralizing Antibody at 12 months
Time Frame: 12 Months
  • Baseline Anti-SARS-CoV-2 IgG Antibody and Neutralizing Antibody levels at 14th day after second dose
  • Change of Anti-SARS-CoV-2 IgG Antibody and Neutralizing Antibody levels at 3 Months after second dose
  • Change of Anti-SARS-CoV-2 IgG Antibody and Neutralizing Antibody levels at 6 Months after second dose
  • Change of Anti-SARS-CoV-2 IgG Antibody and Neutralizing Antibody levels at 12 Months after second dose
12 Months

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.
Karamanoğlu Mehmetbey University

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.
June 1, 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.
June 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.
June 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).
May 14, 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.
May 14, 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.
May 20, 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.
July 15, 2021

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.
July 11, 2021

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.
July 1, 2021

More Information

Terms related to this study

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.
  • 2021-04-30T1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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