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

Recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Anticipated)

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
        • Karamanoğlu 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

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
Intervention / Treatment
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

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

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)

June 1, 2021

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

May 14, 2021

First Submitted That Met QC Criteria

May 14, 2021

First Posted (Actual)

May 20, 2021

Study Record Updates

Last Update Posted (Actual)

July 15, 2021

Last Update Submitted That Met QC Criteria

July 11, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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