Evaluation of the Efficacy, Safety and Immunogenicity of Inactivated COVID 19 Vaccine(TURKOVAC) in Healthy Population of 18 and 64 Years of Age (Both Inclusive):a Randomized, Double-blind, Phase IIb Clinical Trial

NCT05035238 | Withdrawn Phase 2 DMC

• 1 other identifier: TSB-VAC-COV-TUR-KF2B.03
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the efficacy, immunogenicity and safety of two different strengths (3 µg/0.5 mL and 4,5 µg/0.5 mL) of inactivated COVID 19 Vaccine- TURKOVAC in healthy subjects following 3rd vaccination to demonstrate clinical evidence in prophylaxis of COVID 19.

Conditions

Covid19

Keywords

Inactivated vaccine; Phase IIb; Severe acute respiratory syndrome

Outcome Measures

Primary Outcomes (4)

• Efficacy Outcome

  comparison of the seroconversion rate-at least 4-fold rise of antibody concentration/titre from pre- to post-vaccination

  on day 14 and 28 after 3rd vaccination

• Efficacy Outcome

  comparison of antibody concentrations (GMC) or titres (GMT) from pre- to post-vaccination; Specific ELISA antibody titres against SARS-COV-2 spike glycoprotein

  on day 14 and 28 after 3rd vaccination

• Efficacy Outcome

  comparison of neutralizing antibodies and cytokine (TNF-alpha, IFN-γ, IL-2, IL-4, IL-5 and IL-6) from pre- to post-vaccination

  on day 14 and 28 after 3rd vaccination

• Efficacy outcome

  • comparison of antibody responses levels of minimum of 40 participants to convalescent serum plasma obtained from WHO from pre- to post-vaccination

  on day 14 and 28 after 3rd vaccination

Secondary Outcomes (1)

• Safety outcome

  12 months

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

3 μg / 0.5 mL

Biological: Triple dose vaccination by inactivated Covid19 vaccine

Arm 2

ACTIVE COMPARATOR

4,5 μg / 0.5 mL

Biological: Triple dose vaccination by inactivated Covid19 vaccine

Interventions

Triple dose vaccination by inactivated Covid19 vaccine BIOLOGICAL

triple dose intramuscular vaccine on Day 0, Day 28, and Day 120.

Arm 1; Arm 2

Eligibility Criteria

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

You may qualify if:

• Caucasian race, 18 to 64 years of age male or female (both inclusive),
• accepting not to participate in another COVID-19 vaccine study until the end of the study,
• voluntarily gives written informed consent prior to any study-related procedures.
• has a Body Mass Index (BMI) of 18.5-32.0 kg/m2-both inclusive,
• has a normal/acceptable ECG result
• for female volunteers of childbearing potential, a negative serum pregnancy test within seven days before vaccination:
• Females of childbearing potential are defined as fertile following menarche and until becoming postmenopausal or permanently sterile. (Postmenopausal is defined as absence of vaginal bleeding or spotting for at least one year. Permanently sterile is defined as having had a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.)
• for female volunteers of childbearing potential, volunteers who do not plan to get a child in the next one year; a willingness to use highly effective\* contraceptive measures adequate to prevent a new pregnancy for the duration of the study, including for at least 12 months after receiving the first dose of study vaccination. For women with reproductive potential who use a hormonal method of contraception, concurrent use of a second (barrier) method is recommended.
• \* Highly effective methods of birth control are defined as those that result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly (e.g. implants, injectables, oral contraceptives, some intrauterine devices, bilateral tubal occlusion, true sexual abstinence in line with the preferred and usual lifestyle of the volunteer, or vasectomized partner).
• for sexually active males, a willingness to use contraceptive measures, e.g. a condom, for the duration of the study, including for at least three months after receiving the last dose of study vaccination. In addition, males must agree not to donate sperm over the same study period and for at least three months after receiving the last dose of study vaccination.
• anti-SARS CoV 2 total antibody (including COVID-19 IgG and/or IgM) negative in serum.
• physical examination, if indicated only (general state and abnormal findings per system: endocrine/metabolic, allergies, drug sensitivities, head, neck, eyes, ears, nose, throat, cardiovascular, respiratory, gastrointestinal, hepatic/biliary, urogenital, musculoskeletal, lymph nodes, skin, and neurological/psychiatric) should be normal/acceptable.

You may not qualify if:

• clinically significant infection or other acute illness not due to SARS-CoV-2, including fever ≥ 37.4°C within 24 hours prior to the planned study vaccination.
• had close contact to persons with confirmed SARS-CoV-2 infection within 14 days prior to screening Visit 1.
• has participated in a clinical study involving an investigational SARS-CoV-2 vaccine.
• has a history of SARS-CoV-1 or MERS infection (self-reported).
• positive test results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
• has received any vaccine within 30 days prior Visit 1 other than the study intervention, with the exception of the seasonal influenza vaccination.
• has abnormal findings in any required study investigations (including medical history, vital signs, physical examination, and clinical laboratory) considered clinically relevant by the Investigator.
• with either medical history of or present acute or progressive, unstable or uncontrolled clinical conditions that pose a risk for participation or completion of the study, based on Investigator's clinical judgement.
• with underlying diseases with a high risk of developing severe COVID-19 symptoms if infected.
• has a known or suspected defect of the immune system, such as subjects with congenital or acquired immune deficiency.
• received immuno-suppressive therapy within four weeks prior to Visit 1 or receipt of immunosuppressive therapy is expected during the study.
• has a history of any vaccine related contraindicating event.
• presents with clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
• has donated blood, blood fractions or plasma within four weeks prior to Visit 1 or received blood-derived products (e.g., plasma) within 12 weeks prior to Visit 1 in this study or plans to donate blood or use blood products during the study.
• with clinically significant bleeding disorder (e.g., factor deficiency, coagulopathy or platelet disorder) or prior history of significant bleeding or bruising following IM injections or venipuncture.

Sponsors & Collaborators

• Health Institutes of Turkey: lead
• Mene Research: collaborator
• TC Erciyes University: collaborator

Study Sites (1)

Erciyes University Hakan Çetinsaya Iyi Klinik Uygulama ve Arastirma Merkezi, IKUM (Center for GCP)

Kayseri, 38038, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome

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

• ZAFER SEZER

  Erciyes University Hakan Çetinsaya Iyi Klinik Uygulama ve Arastirma Merkezi, IKUM (Center for GCP)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Each subject will receive triple intramuscular dose of TURKOVAC 3 µg/0.5 mL or 4,5 µg/0.5 mL Vaccine on Day 0, Day 28, and Day 120. 200 healthy subjects in both genders will be dosed in double blinded groups with 1:1 randomization ratio.

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 5, 2021
• Study Start: October 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: May 28, 2025

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)