Observational National Vaccine Study

NCT05863429 | Completed

• 1 other identifier: TBS-VAC-COV-TUR-GF4.07
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 8

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.

Conditions

COVID-19 Infection

Keywords

COVID-19; Effectiveness; Immunogenicity; Safety; Observational

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse reactions

  Incidence of adverse reactions in all subjects within 3 - 7 days after vaccination (phone call).

  3 - 7 days after vaccination

• 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 Outcomes (1)

• 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)

Other Outcomes (3)

• 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)

• Determine the confirmed COVID-19 case rates

  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

Study Arms (3)

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

Previously primary vaccinated individuals

1. Those who have previously received two doses of Sinovac - Coronavac vaccine, who will receive the booster vaccine for the first time as TURKOVAC; 2. Those who have previously received two doses of the BioNTech Comirnaty vaccine, who will receive the booster vaccine for the first time as TURKOVAC; 3. 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, 4. 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

Interventions

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

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 never been vaccinated against COVID-19; Individuals who have only received TURKOVAC vaccine before; Previously primary vaccinated individuals

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy adults aged 18 years and older

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Health Institutes of Turkey: lead

Study Sites (8)

Ankara City Hospital Internal Medicine Clinic

Ankara, 06800, Turkey (Türkiye)

Location

T.R. Ministry of Health Abant Izzet Baysal University Training and Research Hospital

Bolu, 14280, Turkey (Türkiye)

Location

Eskişehir City Hospital Internal Medicine

Eskişehir, 26080, Turkey (Türkiye)

Location

T.R. Ministry of Health Kartal Dr. Lütfi Kirdar City Hospital Infectious Diseases

Istanbul, 34865, Turkey (Türkiye)

Location

Kayseri City Training and Research Hospital, Department of Infectious Diseases and Clinical Microbiology

Kayseri, 38080, Turkey (Türkiye)

Location

Erciyes University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology

Kayseri, 38280, Turkey (Türkiye)

Location

Health Sciences University Derince Training and Research Hospital

Kocaeli, 41310, Turkey (Türkiye)

Location

Health Sciences University Kanuni Training and Research Hospital Infectious Diseases and Clinical Microbiology

Trabzon, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples from volunteers who accepted the study will be used to evaluate the long-term safety and immunogenicity of the TURKOVAC vaccine.

MeSH Terms

Conditions

COVID-19

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• İhsan Ateş, Assoc. Prof.

  Assoc. Prof.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: May 18, 2023
• Study Start: May 18, 2022
• Primary Completion: November 1, 2023
• Study Completion: April 1, 2024
• Last Updated: May 24, 2024

Record last verified: 2024-05

Locations

TU (8)