Observational National Vaccine Study

COVID-19 Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05863429
• Other study ID #: TBS-VAC-COV-TUR-GF4.07
• Status: Completed
• Start date: May 18, 2022
• Est. completion date: April 1, 2024

Study information

• Verified date: May 2024
• Source: Health Institutes of Turkey
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 1, 2024
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

1. Individuals aged 18 and over,

2. 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),

3. Individuals who have not had COVID-19 during the last trimester,

4. 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,

5. 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,

6. Individuals who will be able to voluntarily understand and sign informed consent,

7. 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.

1. 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.

2. Individuals who have chosen a vaccine other than TURKOVAC as a booster dose.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Infection

Intervention

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.

Locations

Country	Name	City	State
Turkey	Ankara City Hospital Internal Medicine Clinic	Ankara
Turkey	T.R. Ministry of Health Abant Izzet Baysal University Training and Research Hospital	Bolu
Turkey	Eskisehir City Hospital Internal Medicine	Eskisehir
Turkey	T.R. Ministry of Health Kartal Dr. Lütfi Kirdar City Hospital Infectious Diseases	Istanbul
Turkey	Erciyes University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology	Kayseri
Turkey	Kayseri City Training and Research Hospital, Department of Infectious Diseases and Clinical Microbiology	Kayseri
Turkey	Health Sciences University Derince Training and Research Hospital	Kocaeli
Turkey	Health Sciences University Kanuni Training and Research Hospital Infectious Diseases and Clinical Microbiology	Trabzon

Sponsors (1)

Lead Sponsor	Collaborator
Health Institutes of Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Microneutralization levels	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)	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)
Other	Determine the confirmed COVID-19 case rates	To determine the confirmed COVID-19 case rates by symptomatic RT-PCR at least 14 days after the second dose of TURKOVAC vaccine	At least 14 days after the second dose of TURKOVAC vaccine
Other	Neutralizing antibody (pseudo neutralization-Neutralizing Anti Spike/RBD Antibody) levels and microneutralization levels	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	Before the fourth dose of TURKOVAC vaccine is given and on the 28th (±2 days) day following the booster dose of vaccine
Primary	Incidence of adverse reactions	Incidence of adverse reactions in all subjects within 3 - 7 days after vaccination (phone call).	3 - 7 days after vaccination
Primary	Incidence of Serious Adverse Events (SAE)	Incidence of Serious Adverse Events (SAE) up to 365 days after vaccination in all subjects	365 days after vaccination
Secondary	Neutralizing antibody (pseudo neutralization-Neutralizing Anti Spike/RBD Antibody) levels	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)	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)