epidemiologyЭпидемиология и ВакцинопрофилактикаEpidemiology and Vaccinal Prevention2073-30462619-0494«Numicom» LLC10.31631/2073-3046-2017-16-3-58-64epidemiology-277Research ArticleОФИЦИАЛЬНАЯ ИНФОРМАЦИЯOFFICIAL INFORMATIONСравнительное рандомизированное исследование переносимости, реактогенности, безопасности и иммуногенности вакцины «БиВак полио» (вакцина полиомиелитная пероральная 1, 3 типов)Comparative Randomized Study of Tolerability, Reactogenicity, Immunogenicity and Safety of the Vaccine «BiVac Polio» (Oral Poliovirus Vaccine Type 1,3)ХапчаевЮ. Х.KhapchaevYu. H.noemail@neicon.ruИвановаО. Е.IvanovaO. E.noemail@neicon.ruВоровичМ. Ф.VorovitchM. F.noemail@neicon.ruРоманенкоВ. В.RomanenkoV. V.noemail@neicon.ruМакаровА. Е.MakarovA. E.noemail@neicon.ruДроздовС. Г.DrozdovS. G.noemail@neicon.ruИшмухаметовА. А.IshmukhametovA. A.noemail@neicon.ruФГБНУ «ФНЦИРИП им. М.П. Чумакова» РАНРоссияFederal State Budgetary Scientific Institution «Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products» of Russian Academy of SciencesRussian FederationФБУЗ «Центр гигиены и эпидемиологии в Свердловской области»; ФГБУ ВО «Уральский государственный медицинский университет» Минздрава РоссииРоссияFederal Budget Health Institution «Center for Hygiene and Epidemiology in the Sverdlovsk region»; Federal State Institution of Higher Education «Ural State Medical University» of Ministry of Health of RussiaRussian FederationФГБУ ВО «Уральский государственный медицинский университет» Минздрава РоссииРоссияFederal State Institution of Higher Education «Ural State Medical University» of Ministry of Health of RussiaRussian Federation2017200620171635864Copyright © Хапчаев Ю.Х., Иванова О.Е., Ворович М.Ф., Романенко В.В., Макаров А.Е., Дроздов С.Г., Ишмухаметов А.А., 20172017Хапчаев Ю.Х., Иванова О.Е., Ворович М.Ф., Романенко В.В., Макаров А.Е., Дроздов С.Г., Ишмухаметов А.А.Khapchaev Y.H., Ivanova O.E., Vorovitch M.F., Romanenko V.V., Makarov A.E., Drozdov S.G., Ishmukhametov A.A.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.epidemvac.ru/jour/article/view/277

Представлены рeзультаты клинического исследования переносимости, реактогенности, безопасности и иммунологической эффективности бивалентной вакцины против полиомиелита «БиВак полио», разработанной в ФГБНУ «ФНЦИРИП им. М.П. Чумакова РАН». «БиВак полио» представляет собой препарат из штаммов Сэбина вируса полиомиелита типа 1 (штамм LSc 2ab) и типа 3 (штамм Leon 12a1b). Содержание инфекционных единиц вируса в прививочной дозе составляет не менее 1060 ТЦД50 вируса полиомиелита типа 1 и не менее 1055 ТЦД50 вируса полиомиелита типа 3. В качестве препарата сравнения использовали вакцину полиомиелитную пероральную 1, 2, 3 типов из штаммов Сэбина, раствор для приема внутрь Данные клинических исследований показали, что по своим основным характеристикам вакцина «БиВак полио» не уступает препарату сравнения и может быть использована для профилактики полиомиелита.

Through the use of trivalent oral poliovirus vaccine made from Sabin strains of types 1, 2, 3 (tOPV), outstanding success of Global polio eradication program has been achieved. Since 1999, wild polio virus type 2 does not circulate in the world. To enhance immunity to poliovirus types 1 and 3, to reduce the risk associated with the continued use of tOPV (forming of vaccine-derived polioviruses and the emergence of cases of post-vaccination complications), the WHO proposed its replacement with bivalent oral poliovirus vaccine (bOPV) in programs of mass immunization. The results of clinical studies of tolerability, reactogenicity, safety and immunological effectiveness of the bOPV «BiVac Polio» developed in Chumakov Federal Scientific Center for Research and Development of Immune-and Biological Products of Russian Academy of Sciences are presented. «BiVac Polio» is a preparation of Sabin strains of polio virus type 1 (strain LSc 2ab) and type 3 (strain Leon 12a1b). The content of infectious viral units per vaccination dose is not less than 106 0 TCD50 for poliovirus type 1 and not less than 1055 TCD50 for poliovirus type 3. As a preparation of comparison, trivalent oral poliovirus vaccine from Sabin strains types 1, 2, 3 was used. The study included two stages. Comparative assessment of tolerability, reactogenicity and safety of the vaccine «BiVac Polio» and tOPV was the purpose of the first stage which included 20 adults of both sexes. At the second phase of the study, a comparative investigation of tolerability, safety and immunogenicity of the vaccine«BiVac Polio» and tOPV in children aged 18 months and 6 months was carried out (each group consisted of 60 children). Estimation of vaccine immunogenicity was carried out using the level of seroconversion - rise of neutralizing antibody titers in the sera of recipients taken before and 28 days after vaccination. The titer of neutralizing antibodies in the blood serum to poliovirus type 1 and 3 was determined by microneutralization assay on HEp-2 cells. The results of clinical studies have shown that in their basic characteristics, «BiVac Polio» vaccine is not inferior to the preparation of comparison (tOPV) and may be used for prophylaxis of poliomyelitis.

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The authors declare that there are no conflicts of interest present.