Observational National Vaccine Study

Sponsor

Health Institutes of Turkey (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05863429

Collaborator

(none)

4,000

Enrollment

Locations

23.5

Anticipated Duration (Months)

500

Patients Per Site

21.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To assess the long-term safety of TURKOVAC in individuals who have not previously received the COVID-19 vaccine or who have received their primary vaccination with inactivated or mRNA vaccine, or who have received their primary vaccination with similarly inactivated or mRNA vaccine and who subsequently received the first dose or second dose of booster vaccine, who meet the inclusion/exclusion criteria of the study.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Infection	Biological: Taking biological samples (blood) and keeping records with phone calls

Detailed Description

The primary objective of the study was to evaluate the long-term safety of TURKOVAC in individuals who had never received a COVID-19 vaccine before, or who received their primary vaccination with inactivated or mRNA vaccine, or who received their primary vaccination with similarly inactivated or mRNA vaccine, and who subsequently received a first dose or second dose of booster vaccine, in individuals who met the inclusion/exclusion criteria of the study. The secondary objective of the study was to evaluate the immunogenicity of TURKOVAC in individuals who meet the inclusion/exclusion criteria of the study.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

4000 participants

Observational Model:

Other

Time Perspective:

Other

Official Title:

Observational Study to Evaluate the Effectiveness, Immunogenicity and Safety of Inactivated COVID-19 Vaccine (TURKOVAC) Application

Actual Study Start Date :

May 17, 2022

Anticipated Primary Completion Date :

Jan 30, 2024

Anticipated Study Completion Date :

Apr 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Individuals who have never been vaccinated against COVID-19 Individuals who have never been vaccinated against COVID-19 and who have applied to the study centers to be vaccinated with TURKOVAC within the scope of the routine vaccination program.	Biological: Taking biological samples (blood) and keeping records with phone calls Within the scope of the study, no intervention will be made to the participants. According to the vaccination program implemented in Turkey, subjects who apply to the study centers for TURKOVAC vaccine will be invited to the study.
Previously primary vaccinated individuals Those who have previously received two doses of Sinovac - Coronavac vaccine, who will receive the booster vaccine for the first time as TURKOVAC; Those who have previously received two doses of the BioNTech Comirnaty vaccine, who will receive the booster vaccine for the first time as TURKOVAC; Those who have previously received the primary vaccination of Sinovac - Coronavac Vaccine and who have received at least one dose of the booster vaccine of TURKOVAC and have accepted the second booster dose vaccination, Individuals who have previously received the primary vaccination of the BioNTech Comirnaty Vaccine and who have received at least one dose of the booster vaccine of the TURKOVAC and who have agreed to the second booster dose vaccination.	Biological: Taking biological samples (blood) and keeping records with phone calls Within the scope of the study, no intervention will be made to the participants. According to the vaccination program implemented in Turkey, subjects who apply to the study centers for TURKOVAC vaccine will be invited to the study.
Individuals who have only received TURKOVAC vaccine before Only individuals who have previously been vaccinated of TURKOVAC will also be invited to be included in the study retrospectively.	Biological: Taking biological samples (blood) and keeping records with phone calls Within the scope of the study, no intervention will be made to the participants. According to the vaccination program implemented in Turkey, subjects who apply to the study centers for TURKOVAC vaccine will be invited to the study.

Arm

Intervention/Treatment

Individuals who have never been vaccinated against COVID-19

Individuals who have never been vaccinated against COVID-19 and who have applied to the study centers to be vaccinated with TURKOVAC within the scope of the routine vaccination program.

Biological: Taking biological samples (blood) and keeping records with phone calls

Within the scope of the study, no intervention will be made to the participants. According to the vaccination program implemented in Turkey, subjects who apply to the study centers for TURKOVAC vaccine will be invited to the study.

Previously primary vaccinated individuals

Those who have previously received two doses of Sinovac - Coronavac vaccine, who will receive the booster vaccine for the first time as TURKOVAC; Those who have previously received two doses of the BioNTech Comirnaty vaccine, who will receive the booster vaccine for the first time as TURKOVAC; Those who have previously received the primary vaccination of Sinovac - Coronavac Vaccine and who have received at least one dose of the booster vaccine of TURKOVAC and have accepted the second booster dose vaccination, Individuals who have previously received the primary vaccination of the BioNTech Comirnaty Vaccine and who have received at least one dose of the booster vaccine of the TURKOVAC and who have agreed to the second booster dose vaccination.

Biological: Taking biological samples (blood) and keeping records with phone calls

Individuals who have only received TURKOVAC vaccine before

Only individuals who have previously been vaccinated of TURKOVAC will also be invited to be included in the study retrospectively.

Biological: Taking biological samples (blood) and keeping records with phone calls

Outcome Measures

Primary Outcome Measures

Incidence of adverse reactions [3 - 7 days after vaccination]
Incidence of adverse reactions in all subjects within 3 - 7 days after vaccination (phone call).
Incidence of Serious Adverse Events (SAE) [365 days after vaccination]
Incidence of Serious Adverse Events (SAE) up to 365 days after vaccination in all subjects

Secondary Outcome Measures

Neutralizing antibody (pseudo neutralization-Neutralizing Anti Spike/RBD Antibody) levels [Immediately before the first dose of TURKOVAC vaccine (day 0) and on the following days of 28 (±2 days), 48 (±5 days), 84 (±5 days), and 168 (±10 days)]
Neutralizing antibody (pseudo neutralization-Neutralizing Anti Spike/RBD Antibody) levels (from subjects available) immediately before the first dose of TURKOVAC vaccine (day 0) and on the following days of 28 (±2 days), 48 (±5 days), 84 (±5 days), and 168 (±10 days)

Other Outcome Measures

Microneutralization levels [Immediately before the first dose of TURKOVAC vaccine (day 0) and on the following days 28 (±2 days), 48 (±5 days), 84 (±5 days), and 168 (±10 days)]
Microneutralization levels (from subjects available) immediately before the first dose of TURKOVAC vaccine (day 0) and on the following days 28 (±2 days), 48 (±5 days), 84 (±5 days), and 168 (±10 days)
Determine the confirmed COVID-19 case rates [At least 14 days after the second dose of TURKOVAC vaccine]
To determine the confirmed COVID-19 case rates by symptomatic RT-PCR at least 14 days after the second dose of TURKOVAC vaccine
Neutralizing antibody (pseudo neutralization-Neutralizing Anti Spike/RBD Antibody) levels and microneutralization levels [Before the fourth dose of TURKOVAC vaccine is given and on the 28th (±2 days) day following the booster dose of vaccine]
Neutralizing antibody (pseudo neutralization-Neutralizing Anti Spike/RBD Antibody) levels and microneutralization levels (from subjects available) just before the fourth dose of TURKOVAC vaccine is given and on the 28th (±2 days) day following the booster dose of vaccine

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Subjects who meet all of the following criteria will be included in the study:

Individuals aged 18 and over,
Individuals who have never had a COVID-19 vaccine before OR who have received COVID-19 mRNA or inactivated vaccines in the primary vaccination and have selected TURKOVAC as the booster dose (3rd dose and 4th dose),
Individuals who have not had COVID-19 during the last trimester,
Only for subjects who will receive 4th dose of vaccine: Those who have received the third dose of TURKOVAC vaccine and those who have spent at least 90 days since the third dose,
Individuals who agree to provide blood samples and verifiable identification information (in accordance with local regulations), who may be contacted by the investigator during the study and who may come into contact with the investigator,
Individuals who will be able to voluntarily understand and sign informed consent,
Individuals who accept phone calls to be made to them for the purpose of collecting safety-related data.

Exclusion Criteria:

Subjects who meet one of the following criteria will be excluded from the study.

For subjects who will receive primary vaccination: Individuals who have received any vaccine and/or flu vaccine within 14 days prior to the COVID-19 vaccine.
Individuals who have chosen a vaccine other than TURKOVAC as a booster dose.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Ankara City Hospital Internal Medicine Clinic	Ankara	Turkey	06800
2	T.R. Ministry of Health Abant Izzet Baysal University Training and Research Hospital	Bolu	Turkey	14280
3	Eskişehir City Hospital Internal Medicine	Eskişehir	Turkey	26080
4	T.R. Ministry of Health Kartal Dr. Lütfi Kirdar City Hospital Infectious Diseases	Istanbul	Turkey	34865
5	Kayseri City Training and Research Hospital, Department of Infectious Diseases and Clinical Microbiology	Kayseri	Turkey	38080
6	Erciyes University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology	Kayseri	Turkey	38280
7	Health Sciences University Derince Training and Research Hospital	Kocaeli	Turkey	41310
8	Health Sciences University Kanuni Training and Research Hospital Infectious Diseases and Clinical Microbiology	Trabzon	Turkey