Turkovac Clinical Trials Phase I

TSB-VAC-COV-ERU-F1.0A

"A randomized, double-blind, national, single-centre, placebo-controlled Phase I clinical trial investigating the safety and immunogenicity of two different potencies of the inactive COVID-19 Vaccine ERUCOV-VAC, prepared in cell culture, administered twice via the intramuscular route to healthy volunteers."

The aim of this study was to demonstrate the safety and secondarily the immunogenicity of the newly developed inactive COVID-19 vaccine. The study, which began with the vaccination of the first volunteer on 05.11.2020, was completed one year after the recruitment of the last volunteer on 31.01.2021. 69 volunteers were screened, and 44 volunteers were vaccinated in the study. The research products were administered to 44 volunteers in 3 groups in a double-blind manner. Each volunteer was administered a single intramuscular dose of Inactivated COVID-19 3 μg/0.5 ml Vaccine, Inactivated COVID-19 6 μg/0.5 ml Vaccine, or 0.5 ml placebo Vaccine in a random order on days 0 and 21. Both doses were well tolerated in healthy volunteers, and it was observed that sufficient immunogenicity was generated. The rate of adverse events observed with both doses was found to be similar. No statistically significant difference was found between the humoral immune responses formed after both doses of the vaccine.