Efficacy, Immunogenicity, and Safety of the Inactivated COVID-19 Vaccine (TURKOVAC) Versus the CoronaVac Vaccine

Efficacy, Immunogenicity, and Safety of the Two-Dose Inactivated COVID-19 Vaccine (TURKOVAC) Versus the Two-Dose CoronaVac (Sinovac) Vaccine in Healthy Subjects: A Randomized, Observer-Blinded, Phase III Clinical Trial

Sponsors

Lead Sponsor: Health Institutes of Turkey

Source Health Institutes of Turkey
Brief Summary

This study is a randomized, double-blinded, and active-controlled phase III clinical trial of the SARS-CoV-2 inactivated vaccine. The purpose of this study is to evaluate the efficacy, safety, and immunogenicity of the experimental vaccine in healthy adults aged 18~55 years.

Detailed Description

This study is a randomized, double-blinded, multi-center, active-controlled phase III clinical trial in adults aged 18~55 years. The purpose of this study is to evaluate the efficacy, safety, and immunogenicity of the experimental SARS-CoV-2 inactivated vaccine. A total of 40.800 subjects will be enrolled. The participant will be assigned to receive two doses of experimental vaccine or CoronaVac on the schedule of days 0, 28.

Overall Status Recruiting
Start Date 2021-06-21
Completion Date 2023-03-31
Primary Completion Date 2021-09-21
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Protection Indexes of Two Vaccine Doses For Symptomatic COVID-19. 2 weeks after the second dose of vaccination
Secondary Outcome
Measure Time Frame
To evaluate the efficacy of one dose of CoronaVac with one dose of TURKOVAC for Real Time-PCR-confirmed symptomatic COVID-19 disease. after one dose of vaccination
To assess the safety of TURKOVAC and CoronaVac vaccines. after one dose of vaccination
To assess the immunogenicity of TURKOVAC and CoronaVac vaccines. 14 days after each dose vaccination
To determine the seropositivity rate of SARS-CoV2 specific binding antibody at 42, 56, 70, 168 and 224 days after the first dose. at 42, 56, 70, 168 and 224 days after the first dose.
To evaluate SARS-CoV2 neutralizing antibodies by neutralization test on the first dose day and at 42, 56, 70, 168 and 224 days after the first dose among the subjects vaccinated with TURKOVAC and the subjects vaccinated with CoronaVac. at 42, 56, 70, 168 and 224 days after the first dose
To evaluate the efficacy and hospitalization and death rates of two doses of TURKOVAC vaccine against severe cases of COVID-19. 2 weeks after the second dose of vaccination
To determine the incidence of adverse reactions and serious adverse events. after one dose of vaccination
To evaluate the SARS-CoV2 protein peptide pool-specific T cells (T cell activation) on the first dose day and at 42, 70, 168 and 224 days after the first dose. at 42, 70, 168 and 224 days after the first dose
Enrollment 40800
Condition
Intervention

Intervention Type: Biological

Intervention Name: TURCOVAC

Description: Two doses at 28-day interval, each inoculation dose is 0.5 mL. Two doses of dosage (vaccine contains 600 subunit of SARS-CoV-2 virus antigen) experimental vaccine at the schedule of day 0,28

Arm Group Label: TURKOVAC SARS-COV-2 Vaccine

Intervention Type: Biological

Intervention Name: CoronaVac

Description: Two doses at 28-day interval, each inoculation dose is 0.5 mL. Two doses of dosage (vaccine contains 600 subunit of SARS-CoV-2 virus antigen) vaccine at the schedule of day 0, 28

Arm Group Label: CoronaVac

Eligibility

Criteria:

Inclusion Criteria: Each subject must meet all the following criteria to be enrolled in this study: 1. Subjects consented voluntarily to participate the study, 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. Subjects agreed to adhere to the prohibitions and restrictions specified in this protocol, 4. Subjects, who are sexually active and have childbearing potential, agreed to comply with the contraceptive requirements to be applied in the study, 5. Adult males or females of at least 18 years of age and not older than 55 years of age on the date of the informed consent signature, 6. Subjects who are medically stable (those without severe pain, severe swelling, severe movement limitation, persistent high fever, severe headache or other systemic or local reactions) such that who are not anticipated to hospitalize within the study period, according to the judgment of the Investigator, and the subjects appears likely to be able to continue the study until the follow-up period specified in the protocol, 7. Subjects who are excluded from the criteria to receive the COVID-19 vaccine approved in the scope of Emergency Use Approval in Turkey or subjects who meet the vaccination criteria, but voluntarily chose not to be vaccinated and agreed to receive one of the vaccines to be used in this study. 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. Subjects who are pregnant or breastfeeding. 3. Known history of SARS-CoV-2 infection. 4. 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. 5. 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. 6. Subjects determined as ineligible to the study protocol. 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 family history of coronary artery disease at early ages (presence of before age 55 in men and before age 65 in women). 10. Subjects with morbid obesity (Body mass index (BMI) ≥ 40). 11. Subjects who have a travel plan to out of the city up to 28 days after the second vaccine dose. 12. 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. 13. 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. 14. Subjects who has bleeding disorder considered a contraindication to intramuscular injection or phlebotomy. 15. Immunosuppressive or immunodeficient state (including HIV), asplenia, recurrent severe infections. 16. Subjects who have medical conditions that prioritize them for receipt of approved COVID-19 vaccine in Turkey and has a valid vaccination right within the Ministry of Health vaccination programme. 17. 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 first study vaccination or a licensed inactivated or non-replicating vaccine (any vaccine other than the COVID-19 vaccine) within 14 days before or after first study vaccination. 18. 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. 19. Subjects who received systemic immunoglobulins or blood products within 3 months prior to the Day 0 or plans to receive such products during the study. 20. Investigator site staff members, 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. Exclusion criteria for the second dose of vaccine: 1. Laboratory-confirmed SARS-CoV-2 infection after the first vaccination. 2. In case of an acute disease that has not recovered before the second vaccination or at acute phase of a chronic disease, the investigator should exclude COVID-19, and assess if the acute disease can recover in a short term. 3. New or newly occurred non-compliance with the inclusion/exclusion criteria after the first dose, which will be assessed by the investigator whether the study participation can continue or not.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

55 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Mine Durusu Tanrıöver, Prof. Principal Investigator Faculty Member
Overall Contact

Last Name: Mine Durusu Tanrıöver, Prof.

Phone: +90 (312) 305 12 96

Email: [email protected]

Location
Facility: Status: Contact: Investigator:
T.R. Ministry of Health Ankara City Hospital, Infectious Diseases and Clinical Microbiology Clinic | Ankara, Turkey Region, 06800, Turkey Recruiting Hatica Rahmet Güner, Prof. +90 (312) 552 60 00 [email protected] Hatica Rahmet Güner, Prof. Principal Investigator
Çukurova University Faculty of Medicine, Department of Infectious Diseases | Adana, Turkey Recruiting Ferit Kuşçu, Assoc. Prof. +90 (322) 338 60 60 [email protected] Ferit Kuşçu, Assoc. Prof. Principal Investigator
Hacettepe University Faculty of Medicine Department of Infections Diseases and Clinical Microbiology | Ankara, 06800, Turkey Recruiting Mine Durusu Tanrıöver, Prof. +90 (312) 305 12 96 [email protected] Mine Durusu Tanrıöver, Prof. Principal Investigator
Ankara University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology | Ankara, Turkey Recruiting Alpay Azap, Prof. +90 (312) 508 26 81 [email protected] Alpay Azap, Prof. Principal Investigator
Gazi University Faculty of Medicine, Department of Infectious Diseases | Ankara, Turkey Recruiting Murat Dizbay, Prof. +90 (312) 202 67 67 [email protected] Murat Dizbay, Prof. Principal Investigator
T.R. Ministry of Health Ankara Keçiören Sanatorium Ataturk Chest Diseases and Thoracic Surgery Training and Research Hospital | Ankara, Turkey Recruiting Aydın Yılmaz, Prof. +90 (312) 567 70 00 [email protected] Aydın Yılmaz, Prof. Principal Investigator
T.R. Ministry of Health Ankara Training and Research Hospital Infectious Diseases Clinic | Ankara, Turkey Recruiting Sami Kınıklı, Assoc. Prof. +90 (312) 595 30 00 [email protected] Sami Kınıklı, Assoc. Prof. Principal Investigator
Akdeniz University Faculty of Medicine, Department of Infectious Diseases | Antalya, Turkey Recruiting Özge Turhan, Prof. +90 (242) 249 60 00 [email protected] Özge Turhan, Prof. Principal Investigator
Uludağ University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology | Bursa, Turkey Recruiting Emin Halis Akalın, Prof. +90 (224) 295 00 00 [email protected] Emin Halis Akalın, Prof. Principal Investigator
Dicle University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology | Diyarbakır, Turkey Recruiting Mustafa Kemal Çelen, Prof. +90 (412) 248 80 01 [email protected] Mustafa Kemal Çelen, Prof. Principal Investigator
Gaziantep University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology | Gaziantep, Turkey Recruiting İlkay Karaoğlan, Prof. +90 (342) 360 60 60 [email protected] İlkay Karaoğlan, Prof. Principal Investigator
Acıbadem Atakent Hospital, Infectious Diseases and Clinical Microbiology | Istanbul, Turkey Recruiting İftihar Köksal, Prof. +90 (0212) 404 44 44 [email protected] İftihar Köksal, Prof. Principal Investigator
Cerrahpaşa Faculty of Medicine, Department of Internal Medicine - Department of Infectious Diseases and Clinical Microbiology | Istanbul, Turkey Recruiting Ömer Fehmi Tabak, Prof. +90 (212) 414 20 00 [email protected] Ömer Fehmi Tabak, Prof. Principal Investigator
Istanbul University Istanbul Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology | Istanbul, Turkey Recruiting Serap Şimşek Yavuz, Prof. +90 (212) 414 20 00 [email protected] Serap Şimşek Yavuz, Prof. Principal Investigator
T.R. Ministry of Health Başakşehir Çam ve Sakura City Hospital | Istanbul, Turkey Recruiting Özlem Altuntaş Aydın, Prof. +90 (212) 909 60 00 [email protected] Özlem Altuntaş Aydın, Prof. Principal Investigator
T.R. Ministry of Health Istanbul Provincial Health Directorate Bakirkoy Dr. Sadi Konuk Training and Research Hospital (Yeşilköy Prof.Dr. Murat Dilmener Emergency Hospital) | Istanbul, Turkey Recruiting Kadriye Kart Yaşar, Prof. +90 (212) 909 70 00 [email protected] Kadriye Kart Yaşar, Prof. Principal Investigator
T.R. Ministry of Health Istanbul Provincial Health Directorate Prof. Dr. Cemil Taşçıoğlu City Hospital, Infectious Diseases Clinic | Istanbul, Turkey Recruiting Taner Yıldırmak, Assoc. Prof. +90 (212) 314 55 55 [email protected] Taner Yıldırmak, Assoc. Prof. Principal Investigator
T.R. Ministry of Health Istanbul Provincial Health Directorate Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital (Prof. Dr. Feriha Öz Emergency Hospital) | Istanbul, Turkey Recruiting Nurettin Yiyit, Prof. +90 (216) 606 50 00 [email protected] Nurettin Yiyit, Prof. Principal Investigator
T.R. Ministry of Health İstanbul Şişli Hamidiye Etfal Training and Research Hospital, Clinical Microbiology Clinic | Istanbul, Turkey Recruiting İlyas Dökmetaş, Prof. +90 (212) 373 50 00 [email protected] İlyas Dökmetaş, Prof. Principal Investigator
University of Health Sciences İstanbul Ümraniye Training and Research Hospital | Istanbul, Turkey Recruiting Hamdi Levent Doğanay, Prof. +90 (216) 650 76 76 [email protected] Hamdi Levent Doğanay, Prof. Principal Investigator
Ege University Faculty of Medicine Hospital, Department of Infectious Diseasesaculty of Medicine Hospital, Department of Infectious Diseases | İzmir, Turkey Recruiting Hüsnü Pullukçu, Prof. +90 (232) 444 13 43 [email protected] Hüsnü Pullukçu, Prof. Principal Investigator
T.R. Ministry of Health İzmir Provincial Health Directorate Health Sciences University Dr Suat Seren Chest Diseases And Chest Surgery Training And Research Hospital | İzmir, Turkey Recruiting Özgür Batum, Specialist +90 (232) 433 33 33 [email protected] Özgür Batum, Specialist Principal Investigator
T.R. Ministry of Health İzmir Provincial Health Directorate İzmir Health Sciences University Tepecik Training and Research Hospital, Infectious Diseases | İzmir, Turkey Recruiting Şükran Köse, Prof. +90 (232) 469 69 69 [email protected] Şükran Köse, Prof. Principal Investigator
Erciyes University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology | Kayseri, Turkey Recruiting Orhan Yıldız, Prof. +90 (352) 437 49 12 [email protected] Orhan Yıldız, Prof. Principal Investigator
T.R. Ministry of Health Kayseri City Training and Research Hospital, Infectious Diseases and Clinical Microbiology Department | Kayseri, Turkey Recruiting İlhami Çelik, Prof. +90 (352) 315 77 00 [email protected] İlhami Çelik, Prof. Principal Investigator
Kocaeli University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology | Kocaeli, Turkey Recruiting Sıla Akhan, Prof. +90 (262) 303 7563 [email protected] Sıla Akhan, Prof. Principal Investigator
Malatya İnönü University Faculty of Medicine, Department of Infectious Diseases | Malatya, Turkey Recruiting Yaşar Bayındır, Prof. +90 (422) 341 06 60 [email protected] Yaşar Bayındır, Prof. Principal Investigator
Ondokuz Mayıs University Istanbul Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology | Samsun, Turkey Recruiting Esra Aksakal Tanyel, Prof. +90 (362) 312 19 19 [email protected] Esra Aksakal Tanyel, Prof. Principal Investigator
Karadeniz Technical University Medical Faculty Hospital, Department of Infectious Diseases and Clinical Microbiology | Trabzon, Turkey Recruiting Gürdal Yılmaz, Prof. +90 (462) 377 50 00 [email protected] Gürdal Yılmaz, Prof. Principal Investigator
Location Countries

Turkey

Verification Date

2021-06-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: TURKOVAC SARS-COV-2 Vaccine

Type: Experimental

Description: 600 Subunit of SARS-CoV-2 virus antigen, intramuscular injection, two doses given 28 days apart.

Label: CoronaVac

Type: Active Comparator

Description: 600 Subunit of SARS-CoV-2 virus antigen, intramuscular injection, two doses given 28 days apart.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Triple (Participant, Care Provider, Investigator)

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