NCT05210179

Phase 2b Booster Vaccination (TURKOVAC) Against COVID-19

Open-Label, Two Arms, Multi-Centered, Phase 2b Clinical Trial to Determine the Safety, Efficacy, and Immunogenicity of Booster Vaccination (TURKOVAC) Against SARS-CoV-2

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Health Institutes of Turkey · Other Government
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

This study is open-label, two arms, multi-centered, phase 2b clinical trial to determine the efficacy, safety, and immunogenicity of booster vaccination (TURKOVAC) against Covid-19. The primary aim of the study is to evaluate the efficacy of a booster dose of TURKOVAC vaccine administered to subjects who have passed at least 90 days and at most 240 days after the second dose of the first course of Comirnaty (Code name: BNT162b2) vaccine.

Detailed description

This phase 2b study aims to determine the efficacy, safety, and immunogenicity of a booster dose of TURKOVAC vaccine administered to subjects who have passed at least 90 days and at most 240 days after the second dose of the first course of Comirnaty (Code name: BNT162b2) vaccine. Efficacy will be evaluated by spike-specific antibody response and neutralizing antibody levels on days 0, 28 (all subjects), 48, 84 and 168 days (50% of subjects). For the booster dose, subjects will be assigned open-label according to randomization (1:1) for 2 different arms. Comparing the efficacy, safety, and immunogenicity results of different series of TURKOVAC vaccines (TURKOVAC-Koçak and TURKOVAC-Dollvet) produced in different production facilities are the secondary objectives of the study. The booster dose vaccine arms are as follows: * TURKOVAC-Koçak * TURKOVAC-Dollvet

Conditions

• COVID-19
• Sars-CoV-2 Infection

Interventions

Type	Name	Description
BIOLOGICAL	TURKOVAC-Dollvet	TURKOVAC-Dollvet vaccines produced by Dollvet Veterinary Vaccine Pharmaceutical Biological Substance Production Industry Co., Ltd.
BIOLOGICAL	TURKOVAC-Koçak	TURKOVAC-Koçak vaccines produced by Koçak Farma Pharmaceutical and Chemical Industry Co., Ltd.

Timeline

• Start date: 2022-01-24
• Primary completion: 2023-02-25
• Completion: 2023-05-02
• First posted: 2022-01-27
• Last updated: 2023-11-29

Locations

9 sites across 1 country: Turkey (Türkiye)