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COVID-19Phase 2NCT05230940

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

A Phase 2 study testing TURKOVAC and CoronaVac in people with COVID-19 and Sars-CoV-2 Infection, run by Health Institutes of Turkey at 14 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 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. Read more about this study

Who is it for?
Ages 12 to 18 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19, Sars-CoV-2 Infection
What is being tested?
TURKOVAC and CoronaVac
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
14 sitesTurkey (Türkiye)
Study dates
18 Feb 2022to 8 Feb 2024
Phase
Phase 2
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 12 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Each subject must meet all the following criteria to be enrolled in this study:
  • Subjects who can voluntarily consent to participate in the study with their parents or legal representatives,
  • 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),
  • No history of SARS-CoV-2 (within the last 12 months),
  • Consent of sexually active females to use effective contraception during the study,
  • 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,
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  • In the opinion of the investigator, subjects who can comply with the study protocol during the study,
  • 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,
  • Not participating in another clinical trial.

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),
  • 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,
  • Subjects who are pregnancy or breastfeeding plan within (at least) 1 year following the second dose of vaccine,
  • Those with a history of SARS-CoV-2 (within the last 12 months),
  • 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,
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  • 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 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 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),
  • Subjects with morbid obesity (Body Mass Index (BMI) ≥ 40),
  • 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 have bleeding disorder considered a contraindication to intramuscular injection or phlebotomy,
  • Subjects who have immunosuppressive or immunodeficiency state (including HIV), asplenia, recurrent severe infections,
  • 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,
  • 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,
  • To be using an immunostimulant, immune-modifying supplementary drug or herbal product or to have used it in the last month,
  • Subjects who have received systemic immunoglobulin or blood products in the past 12 months, or who plan to receive such products during the study,
  • 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.
  • Subjects who have previously received any COVID-19 vaccines.
  • 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.
  • If there is an adverse event after the first dose or newly occurred non-compliance with the inclusion/exclusion criteria which will be assessed by the investigator whether the study subjects can continue or not.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Turkey (Türkiye)14 sites

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

    Adana

  • Çukurova University Faculty of Medicine Department of Pediatric Infectious Diseases

    Adana

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

    Ankara, 06800

  • Ankara University Faculty of Medicine Department of Pediatric Infectious Diseases

    Ankara

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

    Ankara

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

    Eskişehir

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

    Istanbul

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

    Istanbul

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

    Istanbul

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

    Istanbul

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

    Izmir, 35100

  • 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

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

    Izmir

  • Erciyes University Faculty of Medicine Department of Pediatric Infectious Diseases

    Kayseri

Other trials in Turkey (Türkiye)

About this study

Official title: Multicenter,Randomized,Observational Blind Phase IIB Clinical Trial to Evaluate the Effectiveness,Immunogenicity and Safety of Two Doses of CoronaVac (Sinovac) Vaccine Against Two Doses of Inactivated COVID-19 Vaccine (TURKOVAC) in Healthy Adolescent (12-18 Years) Subjects

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.

Read the 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.

Being tested
TURKOVAC, CoronaVac
Keywords
COVID-19, SARS-CoV-2 Vaccine, Efficacy, Immunogenicity, Safety, Adolescent
Medical subject headings
COVID-19

What participants receive

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

  • TURKOVACBiological

    Inactive COVID-19 Vaccine - TURKOVAC

  • CoronaVacBiological

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

Study groups in NCT05230940
Study groupRoleWhat they receive
TURKOVACExperimentalThe 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.
Receives: Biological: TURKOVAC
CoronaVacActive comparatorThe 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.
Receives: Biological: CoronaVac

What is being measured

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

  1. COVID-19 Positivity Rate

    The rate of positivity in a polymerase chain reaction (PCR) sample taken within 24 or 48 hours in subjects (symptomatic subject) with fever and other COVID-19 symptoms 14 days after the second vaccination dose.

    Measured: 14 days after the second dose of vaccination

Secondary outcomes (11)

  1. Protection Rates of TURKOVAC and CoronaVac Vaccines Against Symptomatic COVID-19

    Protection rates of TURKOVAC and CoronaVac vaccines against symptomatic COVID-19 confirmed by real time-polymerase chain reaction (RT-PCR), 14 days after first dose of vaccination.

    Measured: 14 days after first dose of vaccination

  2. Protection rates of TURKOVAC and CoronaVac Vaccines Against Symptomatic COVID-19

    Protection rates of TURKOVAC and CoronaVac vaccines against symptomatic COVID-19 confirmed by real time-polymerase chain reaction (RT-PCR), 14 days after second dose of vaccination.

    Measured: 14 days after second dose of vaccination

  3. The Protection Rates of TURKOVAC and CoronaVac Vaccines in Preventing Hospitalization and Death Against Severe COVID-19

    The protection rates of two-doses of TURKOVAC and CoronaVac vaccines in preventing hospitalization and death against severe COVID-19 disease confirmed by real time-polymerase chain reaction (RT-PCR), 14 days after the second dose of vaccination.

    Measured: 14 days after second dose of vaccination

  4. The Incidence of Adverse Events (AEs)

    The incidence of adverse events (AEs) within after up to 30 minutes each dose of vaccination.

    Measured: Up to 30 minutes each dose of vaccination

  5. The Incidence of Undesirable Adverse Event

    The incidence of an undesirable adverse event from the first day of vaccination to the following year after the last dose of vaccination.

    Measured: First day of vaccination to the following year after the last dose of vaccination

  6. The Incidence of Undesirable Adverse Event

    The incidence of undesirable adverse events within 7 days after each vaccination dose.

    Measured: 7 days after each vaccination dose

  7. The Incidence of Serious Undesirable Adverse Events

    The incidence of serious undesirable adverse events up to one year after first and second dose vaccination.

    Measured: 1 year after first and second dose vaccination

  8. The Seropositivity Rate of SARS-CoV2 Specific Binding Antibody

    The seropositivity rate of SARS-CoV2 specific binding antibody at 42, 56, 70, 126, 168, and 224 days after the first dose of TURKOVAC and CoronaVac vaccination.

    • The change in the geometric mean concentration (GMC) SARS-CoV2 anti-spike protein immunoglobulin G in the 42nd and 56th day compared to the baseline is 2 times.

    Measured: 42, 56, 70, 126, 168, and 224 days after the first dose of vaccination

  9. Evaluation of SARS-CoV2 Neutralizing Antibodies

    To evaluate SARS-CoV2 neutralizing antibodies by neutralization test at 42, 56, 70, 126, 168, and 224 days after the first dose of TURKOVAC and CoronaVac vaccination.

    • The change in the geometric mean concentration (GMC) and geometric mean titer (GMT) SARS-CoV2 neutralizing antibodies in the 42nd and 56th day compared to the baseline is 2 times.

    Measured: 42, 56, 70, 126, 168, and 224 days after the first dose of vaccination

  10. T-Cell Evaluation

    To evaluate the SARS-CoV2 protein-peptide pool-specific T cells (T cell activation) on the first dose day and at 70, 126, and 224 days after the first dose. Geometric mean percentage (minimum 25 percent, maximum 75 percent) of SARS-CoV2 protein-peptide pool-specific T-cell determined by flow cytometry.

    • The success criterion for T cell activation is defined as the appearance of an anamnestic response.

    Measured: 70, 126, and 224 days after the first dose of vaccination

  11. The Incidence of Local and Systemic Signs and Symptoms

    The incidence of local and systemic signs and symptoms in TURKOVAC and CoronaVac vaccines will be evaluated with the chi-square test when the chi-square condition is provided, and the Fisher Exact Test when the chi-square condition is not provided.

    Measured: Through study completion, an average of 1 year

Timeline

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

  1. First posted9 Feb 2022
  2. Study start18 Feb 2022
  3. Primary completion15 May 2023
  4. Study completion8 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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multi-Centered, Randomized, National, Observer-blinded, Active-controlled, Phase IIB
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05230940
Sponsor's protocol ID
TSB-VAC-COV-TUR-EF2B.06
Status last verified
Feb 2024
First submitted
5 Feb 2022
Last updated
28 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TURKOVAC and CoronaVac in people with COVID-19 and Sars-CoV-2 Infection, run by Health Institutes of Turkey at 14 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 9 inclusion and 23 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 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

COVID-19 Positivity Rate (time frame: 14 days 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 NCT05230940.

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 28 May 2024.

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