Turkovac Phase II Clinical Trials

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 ERUCOV-VAC, an Inactive COVID-19 Vaccine Produced in Cell Culture, Administered Intramuscularly Twice to Healthy Volunteers.”

The objective of this study is to demonstrate the efficacy and immunogenicity of the developed inactivated COVID-19 vaccine, with safety as a secondary objective. The study commenced with the enrolment of the first volunteer on February 10, 2021, and was completed one year after the final volunteer was enrolled on June 5, 2021. A total of 376 volunteers were screened, and 250 volunteers were vaccinated. 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 within the 18–62 age range. 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.