biopreparatБИОпрепараты. Профилактика, диагностика, лечениеBiological Products. Prevention, Diagnosis, Treatment2221-996X2619-1156Scientific Centre for Expert Evaluation of Medicinal Products10.30895/2221-996X-2018-18-1-42-49biopreparat-120Research ArticleОБЗОРЫREVIEWSЭффективность и безопасность вакцин для профилактики холерыEfficacy and Safety of Cholera VaccinesГоряевА. А.GoryaevA. A.

Заместитель начальника управления экспертизы противобактериальных МИБП Центра экспертизы и контроля МИБП, канд. биол. наук

Российская Федерация, 127051, Москва, Петровский бульвар, д. 8, стр. 2

Deputy Head of the Division for Expert Evaluation of  Antibacterial Medicinal Immunobiological Products of the  Centre for Evaluation and Control of Medicinal  Immunobiological Products. Candidate of Biological Sciences

8/2 Petrovsky boulevard, Moscow 127051, Russian Federation

Goryaev@expmed.ruСаяпинаЛ. В.SayapinaL. V.

Главный эксперт управления экспертизы противобактериальных МИБП Центра  экспертизы и контроля МИБП, д-р мед. наук

Российская Федерация, 127051, Москва, Петровский бульвар, д. 8, стр. 2

Chief Expert of the Division for Expert Evaluation of  Antibacterial Medicinal Immunobiological Products of the  Centre for Evaluation and Control of Medicinal  Immunobiological Products. Doctor of Medical Sciences

8/2 Petrovsky boulevard, Moscow 127051, Russian Federation

ОбуховЮ. И.ObukhovYu. I.

Начальник управления экспертизы противобактериальных МИБП Центра  экспертизы и контроля МИБП

Российская Федерация, 127051, Москва, Петровский бульвар, д. 8, стр. 2

Head of the Division for Expert Evaluation of Antibacterial  Medicinal Immunobiological Products of the Centre for Evaluation and Control of Medicinal Immunobiological Products

8/2 Petrovsky boulevard, Moscow 127051, Russian Federation

БондаревВ. П.BondarevV. P.

Директор Центра экспертизы и контроля МИБП, д-р мед. наук, профессор

Российская Федерация, 127051, Москва, Петровский бульвар, д. 8, стр. 2

Director of the Centre for Evaluation and Control of Medicinal  Immunobiological Products. Doctor of Medical Sciences, Professor

8/2 Petrovsky boulevard, Moscow 127051, Russian Federation

Федеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииРоссияFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationRussian Federation2018260320181814249Copyright © Горяев А.А., Саяпина Л.В., Обухов Ю.И., Бондарев В.П., 20182018Горяев А.А., Саяпина Л.В., Обухов Ю.И., Бондарев В.П.Goryaev A.A., Sayapina L.V., Obukhov Y.I., Bondarev V.P.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.biopreparations.ru/jour/article/view/120

Холера — острое диарейное заболевание, вызываемое токсигенными штаммами Vibrio cholerae О1 и О139 серогрупп, по-прежнему остается одной из основных проблем мирового  здравоохранения. Несмотря на существующие методы лечения и улучшение качества  питьевой воды, санитарии и гигиены, ежегодно от холеры, по оценкам ВОЗ, умирают около  100000 человек. В последние годы одним из эффективных способов предупреждения и  ликвидации эпидемий холеры является применение оральных холерных вакцин. Согласно  Глобальной дорожной карте ВОЗ, массовая вакцинация должна помочь к 2030 г. добиться  снижения смертности от холеры на 90 % в мире и элиминирования заболевания в 20  странах. В обзоре изложены основные исторические этапы создания холерных вакцин:  парентеральных, химических, инактивированных и живых оральных вакцин. Представлено  сравнительное описание состава действующих и вспомогательных веществ вакцин  Dukoral®, mORC-VAX®, Shanchol®, Euvichol®, Vaxchora®, Oravacs® и вакцины холерной  бивалентной химической. Проанализированы результаты международных многоцентровых клинических исследований оральных инактивированных, живой и химической холерных  вакцин. Рассмотрены вопросы, касающиеся изучения эффективности и безопасности вакцин, используемых для профилактики холеры.

Cholera is an acute diarrheal disease caused by toxigenic strains of Vibrio cholerae O1 and O139 serogroups. It still remains a major  global healthcare problem. According to WHO, about 100,000 people die from cholera every year, despite the modern methods of  treatment, improvement in the quality of drinking water, sanitation and hygiene. In recent years, oral cholera vaccines have proved an  effective tool for preventing and curbing cholera epidemics.  According to the WHO Ending Cholera — A Global Roadmap, mass  vaccination should help reduce the mortality resulting from cholera  by 90 % worldwide by 2030 and eliminate the disease in 20  countries. The review outlines the main historical stages in the  development of cholera vaccines: parenteral, chemical, inactivated and live oral vaccines. The paper compares active  ingredients and excipients used in Dukoral®, mORC-VAX®, Shanchol®, Euvichol®, Vaxchora®, Oravacs® and the cholera bivalent chemical vaccine. The results of international multicenter clinical trials of oral inactivated, live and  chemical cholera vaccines are analysed. Issues related to efficacy and safety studies of cholera vaccines are considered.

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