The first phase of the clinical trial is an open trial. The study will enroll 14 men and women aged 18 to 30 years, inclusive, who meet the inclusion criteria and have no exclusion criteria, whose data will be used for subsequent analysis of safety and immunogenicity.~The second phase of the clinical trial is a simple, blind, placebo-controlled, randomized, parallel-group study. The study will enroll 86 men and women aged 18 to 60 years, inclusive, who meet the inclusion criteria and have no exclusion criteria whose, the data will be used for subsequent analysis of safety and immunogenicity.~If volunteers drop out of the study, they will not be replaced.
The aim of the clinical study is to determine the safety, reactogenicity and immunogenicity parameters of the EpiVacCorona vaccine in volunteers aged 18-60 years.~The research tasks are to:~evaluate the safety of the EpiVacCorona vaccine when administered twice intramuscularly;~evaluate the reactogenicity of the EpiVacCorona vaccine when administered twice intramuscularly;~identify the development of adverse reactions to vaccine administration;~study the humoral and cellular immune responses following two doses of the EpiVacCorona vaccine.