Efficacy, Immunogenicity, and Safety of TURKOVAC Vaccine Versus the CoronaVac Vaccine Against COVID-19 in Healthy Adolescent

NCT ID: NCT05230940

Last Updated: 2024-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-18
• Study Completion Date: 2024-02-08

Brief Summary

This study is a multi-center, randomized, national, observer-blinded, active-controlled phase IIB clinical trial to determine the efficacy, immunogenicity, and safety of two-doses of inactive COVID-19 vaccine (TURKOVAC) vaccine versus the two-doses CoronaVac (Sinovac) vaccine in healthy adolescents aged 12-18 years.

Detailed Description

The primary aim of the study is to evaluate the clinical efficacy of two-doses of TURKOVAC and two-doses of CoronaVac vaccines against symptomatic COVID-19 disease confirmed by real time-polymerase chain reaction (RT-PCR) in adolescents (12-18 years of age).

After the second dose of vaccine administration, the immunological responses of TURKOVAC and CoronaVac vaccines will be demonstrated by neutralizing antibodies and anti-spiked antibodies.

A total of 644 subjects will be enrolled. Subjects will be assigned according to randomization (1:1) for 2 different arms. The assigned vaccine will be administered to subjects in two doses on days 0 and 28.

Conditions

COVID-19; Sars-CoV-2 Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

TURKOVAC

The dose of the TURKOVAC vaccine will be 3 μg/0.5 mL. It will be administered by injection to the left deltoid muscle of the upper arm, two doses are given 28 days apart.

Group Type: EXPERIMENTAL

TURKOVAC

Intervention Type: BIOLOGICAL

Inactive COVID-19 Vaccine - TURKOVAC

CoronaVac

The dose of the CoronaVac vaccine will be 3 μg/0.5 mL. It will be administered by injection to the left deltoid muscle of the upper arm, two doses are given 28 days apart.

Group Type: ACTIVE_COMPARATOR

CoronaVac

Intervention Type: BIOLOGICAL

It has 600 subunit of SARS-CoV-2 virus antigen

Interventions

TURKOVAC

Inactive COVID-19 Vaccine - TURKOVAC

Intervention Type: BIOLOGICAL

CoronaVac

It has 600 subunit of SARS-CoV-2 virus antigen

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

Each subject must meet all the following criteria to be enrolled in this study:

1. Subjects who can voluntarily consent to participate in the study with their parents or legal representatives,

2. Subjects agreed to comply with all study visits and procedures (consented to give blood sample and nasopharyngeal swab, and receiving automated telephone calls from the study site),

3. No history of SARS-CoV-2 (within the last 12 months),

4. Consent of sexually active females to use effective contraception during the study,

5. Adolescent males or females who were at least 12 years old and not older than 18 years of age on the date of the informed consent signature,

6. In the opinion of the investigator, subjects who can comply with the study protocol during the study,

7. According to the vaccination program of the Ministry of Health, meeting the criteria for vaccination however, who voluntarily choose not to be vaccinated when rights are granted and subjects who agreed to receive one of the vaccines to be used in this study,

8. Not participating in another clinical trial.

Exclusion Criteria

Subjects meeting any of the following criteria will be excluded from the study:

1. Is acutely ill or febrile within 48 hours before or use of antipyretic or analgesic medication within 24 hours before planned administration of study vaccine. (Fever is defined as a body temperature is 38.0 °C. Subjects with mild illness and fever may be enrolled in the study at the discretion of the investigator),

2. Those who have used more than a single dose of Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) in the last 24 hours for a reason other than fever,

3. Subjects who are pregnancy or breastfeeding plan within (at least) 1 year following the second dose of vaccine,

4. Those with a history of SARS-CoV-2 (within the last 12 months),

5. Individuals with a current positive (PCR-based viral RNA detection) or past positive (serological testing or PCR-based viral RNA detection) diagnostic test result for SARS-CoV-2 infection,

6. Prior administration of an investigational or approved coronavirus (SARS-CoV, SARS-CoV-2, MERS-CoV) vaccine or current/planned simultaneous participation in another interventional study to prevent or treat COVID-19,

7. Subjects with a history of cardiac diseases (cardiovascular disease, serious arrythmia, coronary artery disease, heart failure, cardiomyopathies, pulmonary hypertension etc.),

8. Subjects with uncontrolled hypertension,

9. Subjects with a first-degree relative with a history of coronary artery disease at an early age (presence of coronary artery disease before 55 years of age in males and 65 years of age in females),

10. Subjects with morbid obesity (Body Mass Index (BMI) ≥ 40),

11. Subjects with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention, including but not limited to: systemic or cutaneous lupus erythematosus, autoimmune arthritis/rheumatoid arthritis, Guillain-Barré syndrome, multiple sclerosis, Sjögren's syndrome, idiopathic thrombocytopenia purpura, glomerulonephritis, autoimmune thyroiditis, giant cell arteritis (temporal arteritis), psoriasis, and autoimmune bullous diseases,

12. Subjects with history of severe allergic reaction (i.e., anaphylaxis, generalized urticaria, angioedema, or other significant reaction) to any licensed or investigational vaccine or to any of the constituents of CoronaVac or TURKOVAC,

13. Subjects who have bleeding disorder considered a contraindication to intramuscular injection or phlebotomy,

14. Subjects who have immunosuppressive or immunodeficiency state (including HIV), asplenia, recurrent severe infections,

15. Subjects who received or planned to receive a licensed, live replicating vaccine (any vaccine other than the COVID-19 vaccine) within 28 days before or after the first study vaccination or a licensed inactivated or nonreplicating vaccine (any vaccine other than the COVID-19 vaccine) within 14 days before or after first study vaccination,

16. Subjects who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, e.g., for cancer or an autoimmune disease, within 6 months prior to screening, or planned receipt throughout the study. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before study vaccine administration. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted,

17. To be using an immunostimulant, immune-modifying supplementary drug or herbal product or to have used it in the last month,

18. Subjects who have received systemic immunoglobulin or blood products in the past 12 months, or who plan to receive such products during the study,

19. Investigator, site coordinators, employees of TUSEB or the Clinical Research Organization (CRO) directly involved in the conduct of the study, or site staff members otherwise supervised by the Investigator or immediate family members of any of the previously mentioned individuals.

20. Subjects who have previously received any COVID-19 vaccines.

1. Before the second vaccination, in the case of an unresolved acute illness or in the acute phase of a chronic illness, the investigator should exclude COVID-19 and assess if the acute disease can recover in a short term.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Health Institutes of Turkey

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aslınur Özkaya Parlakay, Prof.

Role: PRINCIPAL_INVESTIGATOR

Faculty Member

Locations

Health Sciences University Adana City Training and Research Hospital, Pediatric Health and Diseases

Adana, , Turkey (Türkiye)

Çukurova University Faculty of Medicine Department of Pediatric Infectious Diseases

Adana, , Turkey (Türkiye)

T.R. Ministry of Health Ankara City Hospital, Pediatric Infectious Diseases Clinic

Ankara, , Turkey (Türkiye)

Ankara University Faculty of Medicine Department of Pediatric Infectious Diseases

Ankara, , Turkey (Türkiye)

Hacettepe University Faculty of Medicine Department of Child Health and Diseases Department of Pediatric Infectious Diseases

Ankara, , Turkey (Türkiye)

Eskişehir Osmangazi University Faculty of Medicine, Department of Child Health and Diseases

Eskişehir, , Turkey (Türkiye)

İstanbul University İstanbul Faculty of Medicine, Department of Pediatric Infectious Diseases

Istanbul, , Turkey (Türkiye)

Marmara University Istanbul Pendik Training and Research Hospital, Pediatric Infectious Diseases Clinic

Istanbul, , Turkey (Türkiye)

T.R. Ministry of Health Istanbul Provincial Health Directorate Prof. Dr. Cemil Taşçıoğlu City Hospital, Pediatric Infectious Diseases Clinic

Istanbul, , Turkey (Türkiye)

University of Health Sciences İstanbul Şisli Hamidiye Etfal Training and Research Hospital, Pediatric Infectious Diseases Clinic

Istanbul, , Turkey (Türkiye)

Ege University Faculty of Medicine, Department of Child Health and Diseases

Izmir, , Turkey (Türkiye)

T.R. Ministry of Health İzmir Provincial Health Directorate İzmir Health Sciences University Tepecik Training and Research Hospital, Clinic of Child Health and Diseases

Izmir, , Turkey (Türkiye)

University of Health Sciences İzmir Dr. Behçet Uz Child Disease and Pediatric Surgery Training and Research Hospital

Izmir, , Turkey (Türkiye)

Erciyes University Faculty of Medicine Department of Pediatric Infectious Diseases

Kayseri, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

TSB-VAC-COV-TUR-EF2B.06

Identifier Type: -

Identifier Source: org_study_id