Turkovac Phase I Clinical Trials

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

“A Randomized, Double-Blind, National, Single-Center, Placebo-Controlled Phase I Clinical Trial Investigating the Safety and Immunogenicity of Two Different Potencies of ERUCOV-VAC, an Inactive COVID-19 Vaccine Produced in Cell Culture, Administered Intramuscularly Twice to Healthy Volunteers.”

The primary objective of this study was to demonstrate the safety of the newly developed inactivated COVID-19 vaccine, with immunogenicity as a secondary objective. The study commenced with the vaccination of the first volunteer on November 5, 2020, and was concluded one year after the final volunteer was enrolled on January 31, 2021. A total of 69 volunteers were screened, and the study was conducted with 44 vaccinated volunteers. The investigational products were administered to the 44 volunteers in three groups under double-blind conditions. Each volunteer was randomly assigned to receive either an Inactivated COVID-19 Vaccine (3 μg/0.5 ml), an Inactivated COVID-19 Vaccine (6 μg/0.5 ml), or a Placebo (0.5 ml) via a single intramuscular dose on Day 0 and Day 21. Both dose levels were well-tolerated by healthy volunteers, and sufficient immunogenicity was observed. The incidence of adverse events was found to be similar across both dosage groups. Furthermore, no statistically significant difference was observed between the humoral immune responses elicited following both doses of the vaccine.