Comparative Evaluation of Covid-19 Vaccines Response

• Conditions: COVID-19 Vaccines
• Interventions: Biological: Covid-19 Inactive Vaccine, recombinant human adenovirus serotype number 26, mRNA VAccine

• Registration Number: NCT04895007
• Lead Sponsor: Karamanoğlu Mehmetbey University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-05-14
• Study First Submitted QC: 2021-05-14
• Study First Posted: 2021-05-20
• Study Start: 2021-06-01
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-11
• Last Update Posted: 2021-07-15
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group, vaccinated with mRNA Vaccine (Pfizer/BionTEC).	Covid-19 Inactive Vaccine, recombinant human adenovirus serotype number 26, mRNA VAccine	- Any person, male or female, over 18 years of age, were vaccinated with mRNA Vaccine.
Group, vaccinated with recombinant human adenovirus serotype number 26 (rAd26 of Sputnik V).	Covid-19 Inactive Vaccine, recombinant human adenovirus serotype number 26, mRNA VAccine	- Any person, male or female, over 18 years of age, were vaccinated with recombinant human adenovirus serotype number 26.
Group, vaccinated with Inactive Vaccine (Sinovac Life Sciences, Beijing, China).	Covid-19 Inactive Vaccine, recombinant human adenovirus serotype number 26, mRNA VAccine	- Any person, male or female, over 18 years of age, were vaccinated with Inactive Vaccine.

Primary Outcome Measures

Name	Time	Method
Change from baseline in Anti-SARS-CoV-2 IgG Antibody and Neutralizing Antibody at 12 months	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

Trial Locations

Locations (4)

Karamanoglu Mehmetbey University; 🇹🇷 Karaman, Turkey

Tekirdag Namık Kemal University, Faculty of Medicine; 🇹🇷 Tekirdağ, Turkey

Karadeniz Technic University, Faculty of Medicine; 🇹🇷 Trabzon, Turkey

Selcuk University; 🇹🇷 Konya, Turkey