Evaluation of the Efficacy, Safety and Immunogenicity of Inactivated COVID 19 Vaccine (TURKOVAC Inactive) in Healthy Population of 18 and 64 Years of Age (Both Inclusive): a Randomized, Double-blind, Phase IIb Clinical Trial
Overview
- Phase
- Phase 2
- Intervention
- Triple dose vaccination by inactivated Covid19 vaccine
- Conditions
- Covid19
- Sponsor
- Health Institutes of Turkey
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Efficacy Outcome
- Status
- Withdrawn
- Last Updated
- 11 months ago
Overview
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.
Detailed Description
This is a double-blind, triple dose, parallel, randomized design study comparing two different dose levels and immunization regimen of a novel COVID-19 vaccine candidate - TURKOVAC - against SARS-CoV-2 infection, to assess the efficacy and safety of these vaccine strengths after 3rd dose vaccination. This study will also provide more data to assess the efficacy of the 3rd dose vaccination (booster dose) for COVID-19 prophylaxis including comparison to a cohort of standard convalescent serum samples obtained from World Health Organization (WHO). This study will be completed in 12 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm 1
3 μg / 0.5 mL
Intervention: Triple dose vaccination by inactivated Covid19 vaccine
Arm 2
4,5 μg / 0.5 mL
Intervention: Triple dose vaccination by inactivated Covid19 vaccine
Outcomes
Primary Outcomes
Efficacy Outcome
Time Frame: on day 14 and 28 after 3rd vaccination
comparison of neutralizing antibodies and cytokine (TNF-alpha, IFN-γ, IL-2, IL-4, IL-5 and IL-6) from pre- to post-vaccination
Efficacy outcome
Time Frame: on day 14 and 28 after 3rd vaccination
• comparison of antibody responses levels of minimum of 40 participants to convalescent serum plasma obtained from WHO from pre- to post-vaccination
Secondary Outcomes
- Safety outcome(12 months)