Comparative Evaluation of Covid-19 Vaccines Response

Karamanoğlu Mehmetbey University

Status: Unknown

Conditions: COVID-19 Vaccines

Treatments: Biological: Covid-19 Inactive Vaccine, recombinant human adenovirus serotype number 26, mRNA VAccine

Study type: Observational

Funder types: Other

Identifiers

NCT04895007

2021-04-30T1

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1,500 participants in 3 patient groups

Group, vaccinated with Inactive Vaccine (Sinovac Life Sciences, Beijing, China).

Description:

- Any person, male or female, over 18 years of age, were vaccinated with Inactive Vaccine.

Treatment:

Biological: Covid-19 Inactive Vaccine, recombinant human adenovirus serotype number 26, mRNA VAccine

Group, vaccinated with recombinant human adenovirus serotype number 26 (rAd26 of Sputnik V).

Description:

- Any person, male or female, over 18 years of age, were vaccinated with recombinant human adenovirus serotype number 26.

Treatment:

Biological: Covid-19 Inactive Vaccine, recombinant human adenovirus serotype number 26, mRNA VAccine

Group, vaccinated with mRNA Vaccine (Pfizer/BionTEC).

Description:

- Any person, male or female, over 18 years of age, were vaccinated with mRNA Vaccine.

Treatment:

Biological: Covid-19 Inactive Vaccine, recombinant human adenovirus serotype number 26, mRNA VAccine