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

Phase 2

• Conditions: Covid19
• Interventions: Biological: Triple dose vaccination by inactivated Covid19 vaccine

• Registration Number: NCT05035238
• Lead Sponsor: Health Institutes of Turkey

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.

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-01
• Study First Submitted QC: 2021-09-01
• Last Update Submitted: 2021-09-01
• Study First Posted: 2021-09-05
• Last Update Posted: 2021-09-05
• Study Start: 2021-09-20
• Primary Completion: 2022-09-20
• Study Completion: 2022-09-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Triple dose vaccination by inactivated Covid19 vaccine	4,5 μg / 0.5 mL
Arm 1	Triple dose vaccination by inactivated Covid19 vaccine	3 μg / 0.5 mL

Primary Outcome Measures

Name	Time	Method
Efficacy Outcome	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	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 Outcome Measures

Name	Time	Method
Safety outcome	12 months	Adverse events and safety laboratory results

Trial Locations

Locations (1)

Erciyes University Hakan Çetinsaya Iyi Klinik Uygulama ve Arastirma Merkezi, IKUM (Center for GCP); 🇹🇷 Kayseri, Turkey