We present the results of a randomized, double-blind, placebo-controlled, multi-center clinical trial of the tolerability, safety, and immunogenicity of the inactivated whole virion concentrated purified coronavirus vaccine CoviVac in adult volunteers aged 18-60. Safety of the vaccine was assessed in 398 volunteers who received two doses of the vaccine (n=298) or placebo (n=100). The studied vaccine has shown good tolerability and safety. No deaths, serious adverse events (AE), or other significant AE related to vaccination have been detected. The most common AE in vaccinated participants was pain at the injection site (p<0.05). Immunogenicity assessment was performed in 167 volunteers (122 vaccinated and 45 in Placebo Group) separately for the participants who were anti-SARS-CoV-2 nAB negative (69/122 in Vaccine Group and 28/45 in Placebo Group) or positive (53/122 in Vaccine Group and 17/45 in Placebo Group) at screening. At Day 42 after the first immunization the seroconversion rate in participants who were seronegative at screening was 86.9% with average the geometric mean neutralizing antibody (nAB) titer of 1:20. Statistically significant (p<0.05) increase of IFN-γ production by peptide-stimulated T-cells was observed at Days 14 and 21 after the first immunization. In participants who were seropositive at screening but had nAB titers below 1:256 the rate of 4-fold increase in nAB levels was 85.2%, while in the participants with nAB titers >1:256 the rate of 4-fold increase in nAB levels was below 45%. For the participants who were seropositive at screening the second immunization did not lead to a significant increase in nAB titers. In conclusion, inactivated vaccine CoviVac has shown good tolerability and safety, with 86.9% seroconversion rates in participants, who were seronegative at screening. In participants who were seropositive at screening and had nAB titers below 1:256, a single immunization lead to a 4-fold increase in nAB levels in 85.2% cases.

The analysis of the vaccine preventive status of infectious diseases in adults in Russia and various countries of the world is presented in the  article. The problems and directions of improving the immunization of the adult population in Russia are identified.

Вакцинопрофилактика является одним из основных направлений профилактики инфекционных болезней и признана одним из крупнейших достижений XX в. Она рассматривается мировым сообществом как инструмент реализации концепции демографической политики, обеспечивающий снижение заболеваемости, смертности и активное долголетие. Научно обоснована значимость активной иммунизации против гриппа в системе смертности от болезней системы кровообращения, установлена ее роль в предупреждении злокачественных новообразований -рака шейки матки, ануса, вульвы, гепатокарциномы. Во всем мире вакцинация спасает 2-3 млн жизней ежегодно (ВОЗ и ЮНИСЕФ, 2005). Большинство стран мира, включая Россию, имеют надежные программы иммунизации детей, подкрепленные такими инициативами, как расширенная программа иммунизации и Глобальный альянс по вакцинам и иммунизации.В отличие от вакцинации детей, где отработаны организационные и методические принципы

Relevanc. Measles, mumps and rubella, despite many years of vaccination, retain their epidemiological and social significance at the present time. The aim of the work is to study the safety and immunogenicity. Of the vaccine for the prevention of measles, rubella and mumps Vactrivir® in children's immunization. Materials and methods. The safety and immunogenicity of the vaccine was studied in a simple multicenter blind comparative randomized clinical trial involving children aged 12 months and 6 years. Results. The Vactrivir® vaccine is characterized by low reactogenicity, a high safety and immunogenicity profile and is comparable in terms of indicators to the foreign Priorix® vaccine, which has been used in the Russian Federation for specific prevention of measles, rubella and mumps since 2018.