The study will screen a maximum of 4,929 volunteers of both sexes aged 18 and above, of which 3,000 volunteers who meet the inclusion criteria and do not have the exclusion criteria will be randomized:~2,250 volunteers who will be vaccinated with the EpiVacCorona vaccine, twice intramuscularly at a dose of 0.5 ml;~750 volunteers who will be vaccinated with a placebo, twice intramuscularly at a dose of 0.5 ml.~If volunteers drop out of the study, they will not be replaced. All volunteers will be followed up by an investigator physician for 6 months following the first vaccination in order to identify possible late adverse events. In case the volunteer has any late reactions, he/she will be invited to the clinic to correct his/her condition.
The objective of the clinical study is to evaluate the tolerability, safety, immunogenicity and prophylactic efficacy of the EpiVacCorona vaccine in volunteers aged 18 and above.~The study tasks are to:~evaluate the safety of the EpiVacCorona vaccine when administered twice intramuscularly;~evaluate the tolerability of the EpiVacCorona vaccine when administered twice intramuscularly;~identify any adverse events to the administration of the EpiVacCorona vaccine;~investigate the humoral immune response following two doses of the EpiVacCorona vaccine;~investigate the cell-mediated immune response following two doses of the EpiVacCorona vaccine;~evaluate the prophylactic efficacy of the EpiVacCorona vaccine when administered twice intramuscularly.