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Turkovac Clinical Trials Phase II
TSB-VAC-COV-ERU-F2.0B
"A placebo-controlled, randomized, double-blind, single-centre, Phase II clinical trial investigating the efficacy, immunogenicity, and safety of two different potencies of the inactive COVID-19 Vaccine ERUCOV-VAC, administered twice via the intramuscular route to healthy volunteers."
The aim of this study is to demonstrate the efficacy and immunogenicity, and secondarily the safety, of the developed inactive COVID-19 vaccine. The study, which began with the recruitment of the first volunteer on 10.02.2021, was completed one year after the recruitment of the last volunteer on 05.06.2021. 376 volunteers were screened, and 250 volunteers were vaccinated. 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 in the 18–62 age range. 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.