Double-blind, Placebo-controlled, Randomized Study of Tolerability, Safety and Immunogenicity of the Inactivated Whole-virion Concentrated Purified Coronavirus Vaccine, Produced by FSBSI "Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products", on Volunteers at the Age of 18-60 Years

Brief Summary

Detailed Description

The study is divided into 3 stages. At Stages I and II of the study, a maximum of 300 healthy volunteers aged 18 to 60 years should be screened, of which 200 volunteers meeting the inclusion criteria and not non-inclusion criteria, should be included and randomized to study the tolerability and safety of the vaccine. Stage I includes 15 men and women: Group 1 - 10 volunteers who will receive the Vaccine twice with an interval of 14 days intramuscularly in a dose of 0.5 ml with a post-vaccination observation period of 28 days. Group 2 - 5 volunteers who will receive placebo twice with an interval of 14 days intramuscularly at a dose of 0.5 ml with a post-vaccination observation period of 28 days. Stage II includes 185 volunteers: Group 1 - 140 volunteers who will receive the Vaccine twice with an interval of 14 days intramuscularly in a dose of 0.5 ml with a post-vaccination observation period of 28 days. Group 2 - 45 volunteers who received placebo twice with an interval of 14 days intramuscularly in a dose of 0.5 ml with a post-vaccination observation period of 28 days. Stage III of the study, a maximum of 300 volunteers should be screened, of which 200 volunteers, meeting the inclusion criteria and not non-inclusion criteria, should be included and randomized to study the safety and immunogenicity of the vaccine. Group 3 - 150 volunteers who will receive the vaccine twice with an interval of 14 days intramuscularly in a dose of 0.5 ml with a period of post-vaccination observation for 6 months. Group 4 - 50 volunteers who will receive placebo twice with an interval of 14 days intramuscularly in a dose of 0.5 ml with a post-vaccination observation period of 6 months.

Primary Outcomes

Secondary Outcomes

• Geometric mean titer (GMT)(7 and 14 days after the first vaccination / placebo)
• Evaluation of clinically significant abnormalities in vital signs(within 6 months after the first dose frame of vaccine / placebo)
• Evaluation of clinically significant deviations from laboratory parameters(3, 7, 10 and 14 days after the first vaccination; 4, 7, 14 and 28 days after the second vaccination)
• Cases of early termination of participation of volunteers in the study(within 6 months after the introduction of the first dose of vaccine / placebo)
• Assessment of adverse events(within 6 months after the first dose of vaccine / placebo)
• Seroconversion rate [Time frame: 7 and 14 days after first vaccination / placebo](Percentage of volunteers with a fourfold (or more) level of seroconversion in the neutralization reaction and the ELISA reaction on days 7 and 14 after the first dose of vaccine / placebo; on day 7, day 14, day 28, 2 months, 3 months, 4 months, 5 months,)
• Level of γ-IFN and subpopulation composition of T-lymphocytes(7 and 14 days after the first vaccination / placebo)
• Cases of acute respiratory diseases (influenza, acute respiratory infections, COVID-19)(Within 6 months after the second vaccination / placebo)
• Frequency and severity of adverse events(Within 6 months after the first dose of vaccine / placebo)