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Covid19Phase 3NCT04942405

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

A Phase 3 study testing TURCOVAC and CoronaVac in people with Covid19, run by Health Institutes of Turkey at 29 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Covid19
What is being tested?
TURCOVAC and CoronaVac
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,290 participants
Where
29 sitesTurkey (Türkiye)
Study dates
21 Jun 2021to 1 Feb 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.
  • Immunosuppressive or immunodeficient state (including HIV), asplenia, recurrent severe infections.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Laboratory-confirmed SARS-CoV-2 infection after the first vaccination.
  • 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.
  • 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.

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

Turkey (Türkiye)29 sites

  • Çukurova University Faculty of Medicine, Department of Infectious Diseases

    Adana

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

    Ankara, Turkey Region, 06800

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

    Ankara, 06800

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

    Ankara

  • Gazi University Faculty of Medicine, Department of Infectious Diseases

    Ankara

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

    Ankara

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

    Ankara

  • Akdeniz University Faculty of Medicine, Department of Infectious Diseases

    Antalya

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

    Bursa

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

    Diyarbakır

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

    Gaziantep

  • Acıbadem Atakent Hospital, Infectious Diseases and Clinical Microbiology

    Istanbul

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

    Istanbul

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

    Istanbul

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

    Istanbul

  • 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

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

    Istanbul

  • 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

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

    Istanbul

  • University of Health Sciences İstanbul Ümraniye Training and Research Hospital

    Istanbul

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

    Izmir

  • 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

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

    Izmir

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

    Kayseri

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

    Kayseri

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

    Kocaeli

  • Malatya İnönü University Faculty of Medicine, Department of Infectious Diseases

    Malatya

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

    Samsun

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

    Trabzon

Other trials in Turkey (Türkiye)

About this study

Official title: 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

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.

Read the 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.

Conditions
Covid19
Being tested
TURCOVAC, CoronaVac
Keywords
COVID-19, SARS-CoV-2 Vaccine
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TURCOVACBiological

    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

  • CoronaVacBiological

    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

Study groups in NCT04942405
Study groupRoleWhat they receive
TURKOVAC SARS-COV-2 VaccineExperimental600 Subunit of SARS-CoV-2 virus antigen, intramuscular injection, two doses given 28 days apart.
Receives: Biological: TURCOVAC
CoronaVacActive comparator600 Subunit of SARS-CoV-2 virus antigen, intramuscular injection, two doses given 28 days apart.
Receives: Biological: CoronaVac

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 weeks after the second dose of vaccination

Secondary outcomes (8)

  1. To evaluate the efficacy of one dose of CoronaVac with one dose of TURKOVAC for Real Time-PCR-confirmed symptomatic COVID-19 disease.

    The protection rate of, at least, one dose of SARS-CoV-2 vaccine against Real Time-PCR confirmed symptomatic COVID-19.

    Measured: after one dose of vaccination

  2. To assess the safety of TURKOVAC and CoronaVac vaccines.

    The incidence of adverse reactions after one dose of vaccination.

    Measured: after one dose of vaccination

  3. To assess the immunogenicity of TURKOVAC and CoronaVac vaccines.

    The seroconversion rate, seropositivity rate 14 days after each dose vaccination.

    Measured: 14 days after each dose vaccination

  4. To determine the seropositivity rate of SARS-CoV2 specific binding antibody at 42, 56, 70, 168 and 224 days after the first dose.

    The seroconversion rate, seropositivity rate at 42, 56, 70, 168 and 224 days after the first dose.

    Measured: at 42, 56, 70, 168 and 224 days after the first dose.

  5. 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.

    Geometric mean titer and Geometric mean intensity of neutralizing antibody and immunoglobulin G at 42, 56, 70, 168 and 224 days after the first dose.

    Measured: at 42, 56, 70, 168 and 224 days after the first dose

  6. To evaluate the efficacy and hospitalization and death rates of two doses of TURKOVAC vaccine against severe cases of COVID-19.

    The protection rate of a two-dose of SARS-CoV-2 vaccine against rates of hospitalization, disease severity/and death two weeks after the second dose of vaccination.

    Measured: 2 weeks after the second dose of vaccination

  7. To determine the incidence of adverse reactions and serious adverse events.

    The incidence of adverse reactions within after one dose of vaccination.

    Measured: after one dose of vaccination

  8. 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.

    Geometric mean percentage of SARS-CoV2 protein peptide pool specific T-cell determined by flow cytometry.

    Measured: at 42, 70, 168 and 224 days after the first dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2021
  2. Study start21 Jun 2021
  3. Primary completion8 Mar 2023
  4. Study completion1 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,290 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04942405
Sponsor's protocol ID
TSB-VAC-COV-TUR-F3.01
Status last verified
Feb 2024
First submitted
24 Jun 2021
Last updated
29 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 32936826

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TURCOVAC and CoronaVac in people with Covid19, run by Health Institutes of Turkey at 29 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Protection Indexes of Two Vaccine Doses For Symptomatic COVID-19. (time frame: 2 weeks after the second dose of vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04942405, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.

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