Comparative Evaluation of Covid-19 Vaccines Response

NCT ID: NCT04895007

Last Updated: 2021-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-06-01

Brief Summary

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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

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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).

Conditions

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COVID-19 Vaccines

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

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

Intervention Type BIOLOGICAL

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.

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

Intervention Type BIOLOGICAL

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.

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

Intervention Type BIOLOGICAL

Anti-SARS-CoV-2 IgG Antibody and Neutralizing Antibody will be evaluated 2, 6, 12 Months after second dose.

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Karamanoğlu Mehmetbey University

OTHER

Sponsor Role lead

Responsible Party

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Prof.Dr.Taha Bekci

Head of Pulmonary Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Karamanoglu Mehmetbey University

Karaman, , Turkey (Türkiye)

Site Status RECRUITING

Selcuk University

Konya, , Turkey (Türkiye)

Site Status RECRUITING

Tekirdag Namık Kemal University, Faculty of Medicine

Tekirdağ, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Karadeniz Technic University, Faculty of Medicine

Trabzon, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Countries

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Turkey (Türkiye)

Facility Contacts

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Taha T Bekci, Prof.Dr.

Role: primary

+905333787676

Recep Kesli, Prof.Dr.

Role: primary

+905454605460

Nejat Altıntas, Assoc.Prof.Dr.

Role: primary

Tevfik Ozlu, Prof.Dr.

Role: primary

Other Identifiers

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2021-04-30T1

Identifier Type: -

Identifier Source: org_study_id

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