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

NCT04942405 | Completed Phase 3 DMC

• 1 other identifier: TSB-VAC-COV-TUR-F3.01
• Study Type: interventional
• Target: 1,290
• Locations: 1 country
• Sites: 29

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.

Conditions

Covid19

Keywords

COVID-19, SARS-CoV-2 Vaccine

Outcome Measures

Primary Outcomes (1)

• Protection Indexes of Two Vaccine Doses For Symptomatic COVID-19.

  To evaluate the efficacy of two-dose regimen of TURKOVAC and two-dose regimen of CoronaVac vaccines for Real Time-PCR confirmed symptomatic COVID-19 disease.

  2 weeks after the second dose of vaccination

Secondary Outcomes (8)

• 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

Study Arms (2)

TURKOVAC SARS-COV-2 Vaccine

EXPERIMENTAL

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

Biological: TURCOVAC

CoronaVac

ACTIVE COMPARATOR

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

Biological: CoronaVac

Interventions

TURCOVAC BIOLOGICAL

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

TURKOVAC SARS-COV-2 Vaccine

CoronaVac BIOLOGICAL

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

CoronaVac

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Each subject must meet all the following criteria to be enrolled in this study:
• Subjects consented voluntarily to participate the study,
• 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),
• Subjects agreed to adhere to the prohibitions and restrictions specified in this protocol,
• Subjects, who are sexually active and have childbearing potential, agreed to comply with the contraceptive requirements to be applied in the study,
• 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,
• 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,
• 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.

You may not qualify if:

• Subjects meeting any of the following criteria will be excluded from the study:
• 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).
• Subjects who are pregnant or breastfeeding.
• Known history of SARS-CoV-2 infection.
• 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.
• 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.
• Subjects determined as ineligible to the study protocol.
• Subjects with a history of cardiac diseases (cardiovascular disease, serious arrythmia, coronary artery disease, heart failure, cardiomyopathies, pulmonary hypertension etc).
• Subjects with uncontrolled hypertension.
• 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).
• Subjects with morbid obesity (Body mass index (BMI) ≥ 40).
• Subjects who have a travel plan to out of the city up to 28 days after the second vaccine dose.
• 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.
• 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.
• Subjects who has bleeding disorder considered a contraindication to intramuscular injection or phlebotomy.

Sponsors & Collaborators

• Health Institutes of Turkey: lead

Study Sites (29)

T.R. Ministry of Health Ankara City Hospital, Infectious Diseases and Clinical Microbiology Clinic

Ankara, Turkey Region, 06800, Turkey (Türkiye)

Location

Çukurova University Faculty of Medicine, Department of Infectious Diseases

Adana, Turkey (Türkiye)

Location

Hacettepe University Faculty of Medicine Department of Infections Diseases and Clinical Microbiology

Ankara, 06800, Turkey (Türkiye)

Location

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

Ankara, Turkey (Türkiye)

Location

Gazi University Faculty of Medicine, Department of Infectious Diseases

Ankara, Turkey (Türkiye)

Location

T.R. Ministry of Health Ankara Keçiören Sanatorium Ataturk Chest Diseases and Thoracic Surgery Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

T.R. Ministry of Health Ankara Training and Research Hospital Infectious Diseases Clinic

Ankara, Turkey (Türkiye)

Location

Akdeniz University Faculty of Medicine, Department of Infectious Diseases

Antalya, Turkey (Türkiye)

Location

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

Bursa, Turkey (Türkiye)

Location

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

Diyarbakır, Turkey (Türkiye)

Location

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

Gaziantep, Turkey (Türkiye)

Location

Acıbadem Atakent Hospital, Infectious Diseases and Clinical Microbiology

Istanbul, Turkey (Türkiye)

Location

Cerrahpaşa Faculty of Medicine, Department of Internal Medicine - Department of Infectious Diseases and Clinical Microbiology

Istanbul, Turkey (Türkiye)

Location

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

Istanbul, Turkey (Türkiye)

Location

T.R. Ministry of Health Başakşehir Çam ve Sakura City Hospital

Istanbul, Turkey (Türkiye)

Location

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 (Türkiye)

Location

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

Istanbul, Turkey (Türkiye)

Location

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 (Türkiye)

Location

T.R. Ministry of Health İstanbul Şişli Hamidiye Etfal Training and Research Hospital, Clinical Microbiology Clinic

Istanbul, Turkey (Türkiye)

Location

University of Health Sciences İstanbul Ümraniye Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Ege University Faculty of Medicine Hospital, Department of Infectious Diseasesaculty of Medicine Hospital, Department of Infectious Diseases

Izmir, Turkey (Türkiye)

Location

T.R. Ministry of Health İzmir Provincial Health Directorate Health Sciences University Dr Suat Seren Chest Diseases And Chest Surgery Training And Research Hospital

Izmir, Turkey (Türkiye)

Location

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

Izmir, Turkey (Türkiye)

Location

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

Kayseri, Turkey (Türkiye)

Location

T.R. Ministry of Health Kayseri City Training and Research Hospital, Infectious Diseases and Clinical Microbiology Department

Kayseri, Turkey (Türkiye)

Location

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

Kocaeli, Turkey (Türkiye)

Location

Malatya İnönü University Faculty of Medicine, Department of Infectious Diseases

Malatya, Turkey (Türkiye)

Location

Ondokuz Mayıs University Istanbul Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology

Samsun, Turkey (Türkiye)

Location

Karadeniz Technical University Medical Faculty Hospital, Department of Infectious Diseases and Clinical Microbiology

Trabzon, Turkey (Türkiye)

Location

Related Publications (1)

• Pavel STI, Yetiskin H, Aydin G, Holyavkin C, Uygut MA, Dursun ZB, Celik I, Cevik C, Ozdarendeli A. Isolation and characterization of severe acute respiratory syndrome coronavirus 2 in Turkey. PLoS One. 2020 Sep 16;15(9):e0238614. doi: 10.1371/journal.pone.0238614. eCollection 2020.

  PMID: 32936826 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

sinovac COVID-19 vaccine

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

Study Officials

• Mine Durusu Tanrıöver, Prof.

  Faculty Member

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: June 28, 2021
• Study Start: June 21, 2021
• Primary Completion: March 8, 2023
• Study Completion: February 1, 2024
• Last Updated: February 29, 2024

Record last verified: 2024-02

Locations

TU (29)