Journal of microbiology, epidemiology and immunobiologyJournal of microbiology, epidemiology and immunobiology0372-93112686-7613Central Research Institute for Epidemiology15810.36233/0372-9311-2017-3-35-43STUDY OF IMMUNOGENICITY OF A PROTOTYPE VACCINE AGAINST HEPATITIS EGulyaevS. L.noemail@neicon.ruLyashenkoA. A.noemail@neicon.ruChumakovA. M.noemail@neicon.ruSorokinA. A.noemail@neicon.ruGordeichukI. V.noemail@neicon.ruPotemkinI. A.noemail@neicon.ruIsaevaO. V.noemail@neicon.ruKyuregyanK. K.noemail@neicon.ruMikhaylovM. I.noemail@neicon.ruChumakov Federal Scientific Centre of Research and Development of Immune Biological PreparationsRussian Medical Academy of Continuous Professional Education, Mechnikov Research Institute of Vaccines and Sera28062017943354310042019Copyright © 2017, Gulyaev S.L., Lyashenko A.A., Chumakov A.M., Sorokin A.A., Gordeichuk I.V., Potemkin I.A., Isaeva O.V., Kyuregyan K.K., Mikhaylov M.I.2017Aim. Evaluate specific immunogenic activity of a prototype vaccine against hepatitis E (HE). Materials and methods. Non-linear mice, male (n=170), were immunized once intraperitoneally by a prototype vaccine against HE at 5,10 and 20 pg per animal. Anti-HEV IgG were determined by ELISA using species-specific conjugate at days 7,14,21 and 28 after immunization. Experimental samples of the vaccine preparation containing 20 pg of the antigen and compositions of adjuvants based on aluminium hydroxide and immune modulators polyoxidonium and glutoxim were administered to 250 mice split into 25 groups (10 animals per group) to optimize vaccine immuno-genicity. Anti-HEV were determined in mice sera samples at day 28 after the immunization, and mean immunization dose (Ш50) for each composition of the vaccine preparation was calculated. Results. Increase of immunogenicity for the same standard antigen dose (20 pg) for glutoxim adjuvant at 10 mg/ml in aluminium hydroxide solution (0,5 mg/ml) was 51.4%. A non-significant increase of immunogenicity was also observed for vaccine composition with polyoxidonium (1.0 mg/ml), however, it was statistically non-significant when compared with standard adjuvant (aluminium hydroxide at 0,5 mg/ml). Conclusion. The data obtained give evidence regarding high immunogenicity of the vaccine preparation against hepatitis E. Use of glutoxim immune modulator in the composition of the experimental vaccine against hepatitis E ensures highest immunogenicity.hepatitis E virus (HEV)anti-HEVantigenvaccineimmunogenicityвирус гепатита Е (ВГЕ)анти-ВГЕантигенвакцинаиммуногенность[Bryan J.P. et al. Epidemic hepatitis E in Pakistan: Patterns of serologic response and evidence that antibody to hepatitis E virus protects against disease. J. Infect. Dis. 1994, 170 (3): 517-521.][Khuroo M.S., Kamili S., Dar M.Y. Hepatitis E and long-term antibody status. Lancet. 1993, 341 (8856): 1355.][Krawczynski К., Meng X.-J., Rybczynska J. Pathogenetic elements of hepatitis E and animal models of HEV infection. Virus Res. 2011, 161 (1): 78-83.][Li T.-C. et al. Hepatitis E virus transmission from wild boar meat. Emerg. Infect. Dis. 2005, 11 (12): 1958-1960.][Li S.W. et al. Abacterially expressed particulate hepatitis E vaccine: antigenicity, immunogenic-ity and protectivity on primates. Vaccine. 2005, 23 (22): 2893-2901.][Liu P. et al. Transmission of hepatitis E virus from rabbits to cynomolgus macaques. Emerg. Infect. Dis. 2013, 19 (4): 559-565.][Meng X.J. Recent advances in Hepatitis E virus. J. Viral Hepat. 2010b, 17 (3): 153-161.][Meng X.J. Hepatitis E virus: animal reservoirs and zoonotic risk. Vet. Microbiol. 2010a, 140 (3-4): 256-265.][Meng X.J. et al. Hepeviridae. In: Virus taxonomy: ninth report of the International Committee on Taxonomy of Viruses. A.M. King et al. (ed.). London: Elsevier Inc., 2012, 9: 1021-1028.][Purdy M.A. et al. Expression of a hepatitis E virus (HEV)-trpE fusion protein containing epitopes recognized by antibodies in sera from human cases and experimentally infected primates. Arch. Virol. 1992, 123 (3-4): 335-349.][Purdy M.A. et al. Preliminary evidence that atrpE-HEV fusion protein protects cynomolgus macaques against challenge with wild-type hepatitis e virus (HEV). J. Med. Virol. 1993,41 (1): 90-94.][Shrestha M.P. et al. Safety and efficacy of a recombinant hepatitis E vaccine. New Engl. J. Med. 2007, 356 (9): 895-903.][Tei S. et al. Zoonotic transmission of hepatitis E virus from deer to human beings. Lancet. 2003,362 (9381): 371-373.][Tsarev S.A. et al. Successful passive and active immunization of cynomolgus monkeys against hepatitis E. Proc. Natl. Acad. Sci. USA. 1994, 91 (21): 10198-10202.][Zhu F.-C. et al. Efficacy and safety of a recombinant hepatitis E vaccine in healthy adults: a large-scale, randomised, double-blind placebo-controlled, phase 3 trial. Lancet. 2010, 376 (9744): 895-902.]