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Relevance. The presence of pyrogenic impurities in finished dosage forms of concentrated cultural anti-rabies vaccines produced in the Russian Federation is determined using pyrogenicity tests on rabbits (in vivo). In accordance with the decision of the Board of the Eurasian Economic Commission dated September 7, 2018 N 151 «On the approval of guidelines for drawing up a regulatory document on the quality of a medicinal product», one of the requirements for parenteral drugs is the determination of bacterial endotoxins. This document indicates that the regulatory documentation should include a test and an admissibility criterion for bacterial endotoxins (BE) using the horseshoe crab amoebocyte lysate technique.Aims. Experimental evaluation of the possibility of using the LAL-test to determine bacterial endotoxins in national vaccines for the prevention of rabies.Materials and methods. The research of the drug «Cultural antirabies vaccine concentrated inactivated purified» of national production was carried out in accordance with the National Pharmacopoeia of the Russian Federation, General Pharmacopoeia Monograph OFS.1.2.4.0006.15 in three modifications: gel-clot test: methods A, B; turbidimetric kinetic test: method C; chromogenic kinetic test: method D.Results. Was investigated 6 series of the national vaccines for the prevention of rabies from two national manufacturers (using three pharmacopoeial methods). LAL reagent produced by two companies (Charles River Endosafe® and Lonza). In order to confirm the reproducibility of the method, the gel-clot test was carried out at different time intervals by one or two operators. During the research was determined the possibility of using photometric methods (method C and D).Conclusions. The research proved the possibility of determining bacterial endotoxins by methods: gel-clot test (method A), turbidimetric kinetic test (method C) and chromogenic kinetic test (method D). Method B is recommended for quantitative analysis of vaccine without instrumental methods. During the research all national vaccines for the prevention of rabies was free from bacterial endotoxins (no more 25 EU/ml).

Vaccination remains the only way to prevent tick-borne encephalitis (TBE). All TBE vaccines are based on strains of the Far Eastern and European subtypes of TBE virus. Currently, the Siberian subtype of the virus, which differs from the vaccine strains, accounts for 80–100% of the genetic population of TBE virus in most of Russia. The proportion of TBE vaccinated patients among those infected was different from year to year in Russia, e.g. 3.9% in 2012 and 1.5% in 2018, there were also some fatal cases registered among vaccinated patients. In this regard, evaluation of the effectiveness of vaccination against various genetic subtypes of TBE is a promising area of research. The purpose of this study was to summarise the results of studies investigating effectiveness of specific prevention of TBE as regards various genetic subtypes of the virus. The paper analyses data on the effectiveness of TBE vaccination in experimental settings and in real life. It was demonstrated that the use of vaccines for prevention of TBE is effective, provided the vaccination coverage is not less than 80%. The paper cites the data from a long-term study of the stability and protective activity of vaccine immunity against TBE virus strains isolated in highly endemic territories. It was established that TBE vaccines have high immunogenic activity and contribute to the production of stable protective antibodies against the strains of the three genetic subtypes of the virus. Protective efficacy of vaccination depends on the number of vaccinations received, the vaccination scheme, gender and age of those vaccinated. The paper concludes by saying that further studies are needed to assess TBE vaccine efficacy in order to improve vaccination tactics, to better understand causes of morbidity and mortality among vaccinated individuals.

Researches and presents comparative characteristics of protective properties of vaccines EC domestic and foreign production by immunization line BALB/c mice in a standard experiment for estimating the immunogenic activity against virulent strains of TBE virus three genotypes: genotype 1 - the strain «Sof'in», genotype 2 - strain «Absettarov», genotype 3 - strain «Lesopark». The results are of considerable interest in the evaluation of the efficiency and interchangeability of vaccines for the prevention of TBE in areas of natural foci of the disease in Russia. Currently, the circulation of the pathogen in the Russian Federation dominated by the TBE virus strains Siberian subtype (genotype) -more than 70% of virulent strains of TBE virus released into the natural foci of the Urals, Siberia, the Trans-Baikal. In studies on mice of BALB/c did not reveal significant differences in terms of protection (MID50 and DT50) against virulent strains of TBE virus three genotypes - the Far East, Europe and Siberia for three vaccines: «The vaccine encephalitis culture purified concentrated dry» (production Mikhail Chumakov Federal Research Centre for Research and Development of Immunobiological Preparations, Moscow), EntseVir (production Federal State Unitary Enterprise «Scientific and Production Association «Microgen»), FSME-Immun (Baxter AG production, Austria). Vaccines have shown good protection (protective) properties against 3 genotypes of TBE virus. Revealed a lower protective activity of vaccines Entsepur (manufactured by Novartis Vaccines and Diagnostics GmbH & Co. KG, Germany) strains of TBE 1 and 3 genotypes. These results confirm earlier studies to study the humoral response in mice BALB/c in the experiments with double and triple immunization.