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

NCT05230940 | Completed Phase 2 DMC

• 1 other identifier: TSB-VAC-COV-TUR-EF2B.06
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 14

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.

Conditions

COVID-19; Sars-CoV-2 Infection

Keywords

COVID-19; SARS-CoV-2 Vaccine; Efficacy; Immunogenicity; Safety; Adolescent

Outcome Measures

Primary Outcomes (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.

  14 days after the second dose of vaccination

Secondary Outcomes (11)

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

  14 days after first dose of vaccination

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

  14 days after second dose of vaccination

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

  14 days after second dose of vaccination

• The Incidence of Adverse Events (AEs)

  Up to 30 minutes each dose of vaccination

• The Incidence of Undesirable Adverse Event

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

Study Arms (2)

TURKOVAC

EXPERIMENTAL

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.

Biological: TURKOVAC

CoronaVac

ACTIVE COMPARATOR

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.

Biological: CoronaVac

Interventions

TURKOVAC BIOLOGICAL

Inactive COVID-19 Vaccine - TURKOVAC

TURKOVAC

CoronaVac BIOLOGICAL

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

CoronaVac

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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,
• 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.

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),
• 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,
• 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,

Sponsors & Collaborators

• Health Institutes of Turkey: lead

Study Sites (14)

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

Adana, Turkey (Türkiye)

Location

Çukurova University Faculty of Medicine Department of Pediatric Infectious Diseases

Adana, Turkey (Türkiye)

Location

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

Ankara, 06800, Turkey (Türkiye)

Location

Ankara University Faculty of Medicine Department of Pediatric Infectious Diseases

Ankara, Turkey (Türkiye)

Location

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

Ankara, Turkey (Türkiye)

Location

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

Eskişehir, Turkey (Türkiye)

Location

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

Istanbul, Turkey (Türkiye)

Location

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

Istanbul, Turkey (Türkiye)

Location

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

Istanbul, Turkey (Türkiye)

Location

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

Istanbul, Turkey (Türkiye)

Location

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

Izmir, 35100, Turkey (Türkiye)

Location

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)

Location

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

Izmir, Turkey (Türkiye)

Location

Erciyes University Faculty of Medicine Department of Pediatric Infectious Diseases

Kayseri, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Interventions

TURKOVAC; 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

• Aslınur Özkaya Parlakay, Prof.

  Faculty Member

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the study nurse is unblinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Multi-Centered, Randomized, National, Observer-blinded, Active-controlled, Phase IIB

Study Record Dates

• First Submitted: February 5, 2022
• First Posted: February 9, 2022
• Study Start: February 18, 2022
• Primary Completion: May 15, 2023
• Study Completion: February 8, 2024
• Last Updated: May 28, 2024

Record last verified: 2024-02

Locations

TU (14)