Comparative Evaluation of Covid-19 Vaccines Response

COVID-19 Vaccines Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04895007
• Other study ID #: 2021-04-30T1
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: July 2021
• Source: Karamanoglu Mehmetbey University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19 Vaccines

Intervention

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.

Locations

Country	Name	City	State
Turkey	Karamanoglu Mehmetbey University	Karaman
Turkey	Selcuk University	Konya
Turkey	Tekirdag Namik Kemal University, Faculty of Medicine	Tekirdag
Turkey	Karadeniz Technic University, Faculty of Medicine	Trabzon

Sponsors (1)

Lead Sponsor	Collaborator
Karamanoglu Mehmetbey University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Anti-SARS-CoV-2 IgG Antibody and Neutralizing Antibody at 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