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<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="ru"><front><journal-meta><journal-id journal-id-type="publisher-id">biopreparat</journal-id><journal-title-group><journal-title xml:lang="ru">БИОпрепараты. Профилактика, диагностика, лечение</journal-title><trans-title-group xml:lang="en"><trans-title>Biological Products. Prevention, Diagnosis, Treatment</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2221-996X</issn><issn pub-type="epub">2619-1156</issn><publisher><publisher-name>Scientific Centre for Expert Evaluation of Medicinal Products</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.30895/2221-996X-2023-23-1-42-64</article-id><article-id custom-type="elpub" pub-id-type="custom">biopreparat-463</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>Статьи</subject></subj-group></article-categories><title-group><article-title>Прогресс в разработке вакцин для профилактики лихорадки Чикунгунья и перспективы появления на рынке</article-title><trans-title-group xml:lang="en"><trans-title>Chikungunya vaccines: advances in the development and prospects for marketing approval</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-2491-4072</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Отрашевская</surname><given-names>Е. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Otrasheuskaja</surname><given-names>E. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Отрашевская Елена Викторовна</p><p> ул. Свободы, д. 52, г. Красное Село, Санкт-Петербург, 198320</p></bio><bio xml:lang="en"><p>Elena V. Otrasheuskaja</p><p>52 Svobody St., Krasnoe Selo, Saint Petersburg 198320</p></bio><email xlink:type="simple">e.v.otrashevskaya@mail.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-6635-363X</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Трухин</surname><given-names>В. П.</given-names></name><name name-style="western" xml:lang="en"><surname>Trukhin</surname><given-names>V. P.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Трухин Виктор Павлович</p><p> ул. Свободы, д. 52, г. Красное Село, Санкт-Петербург, 198320</p></bio><bio xml:lang="en"><p>Victor P. Trukhin</p><p>52 Svobody St., Krasnoe Selo, Saint Petersburg 198320</p></bio><email xlink:type="simple">truhin64@gmail.com</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-4891-973X</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Меркулов</surname><given-names>В. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Merkulov</surname><given-names>V. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Меркулов Вадим Анатольевич, д-р мед. наук, проф.</p><p>Петровский б-р, д. 8, стр. 2, Москва, 127051</p></bio><bio xml:lang="en"><p>Vadim A. Merkulov, Dr. Sci. (Med.), Professor</p><p>8/2 Petrovsky Blvd, Moscow 127051</p></bio><email xlink:type="simple">merkulov@expmed.ru</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-9731-3681</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Игнатьев</surname><given-names>Г. М.</given-names></name><name name-style="western" xml:lang="en"><surname>Ignatyev</surname><given-names>G. M.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Игнатьев Георгий Михайлович, д-р мед. наук, проф.</p><p>Малый Казенный пер., д. 5а, Москва, 105064</p></bio><bio xml:lang="en"><p>Georgy M. Ignatyev, Dr. Sci. (Med.), Professor</p><p>5a Maly Kazenny Ln., Moscow 105064</p></bio><email xlink:type="simple">marburgman@mail.ru</email><xref ref-type="aff" rid="aff-3"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Федеральное государственное унитарное предприятие «Санкт-Петербургский научно-исследовательский институт вакцин и сывороток и предприятие по производству бактерийных препаратов» Федерального медико-биологического агентства</institution><country>Россия</country></aff><aff xml:lang="en"><institution>The Saint Petersburg Scientific Research Institute of Vaccines and Serums and the Enterprise for the Production of Bacterial Preparations</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>Федеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской Федерации</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Scientific Centre for Expert Evaluation of Medicinal Products</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-3"><aff xml:lang="ru"><institution>Федеральное государственное бюджетное научное учреждение «Научно-исследовательский институт вакцин и сывороток им. И.И. Мечникова»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>I.I. Mechnikov Research Institute of Vaccines and Sera</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2023</year></pub-date><pub-date pub-type="epub"><day>21</day><month>02</month><year>2023</year></pub-date><volume>23</volume><issue>1</issue><issue-title>Вопросы разработки новых противовирусных вакцин</issue-title><fpage>42</fpage><lpage>64</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Отрашевская Е.В., Трухин В.П., Меркулов В.А., Игнатьев Г.М., 2023</copyright-statement><copyright-year>2023</copyright-year><copyright-holder xml:lang="ru">Отрашевская Е.В., Трухин В.П., Меркулов В.А., Игнатьев Г.М.</copyright-holder><copyright-holder xml:lang="en">Otrasheuskaja E.V., Trukhin V.P., Merkulov V.A., Ignatyev G.M.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://www.biopreparations.ru/jour/article/view/463">https://www.biopreparations.ru/jour/article/view/463</self-uri><abstract><p>Лихорадка Чикунгунья представляет собой острое инфекционное заболевание, которое вызывается вирусом Чикунгунья (ЧИКВ) и распространяется комарами. В последние десятилетия эта инфекция зарегистрирована в более чем 100 странах и превратилась в глобальную проблему для здравоохранения. В связи с тем что антигенные различия между генотипами ЧИКВ незначительны и повторные случаи инфицирования практически не регистрируют, вакцина могла бы не только предотвратить заболевание и возможную потерю трудоспособности, но и уменьшить эпидемическое распространение ЧИКВ среди населения.</p><p>Цель работы — анализ направлений разработки вакцинных препаратов для профилактики лихорадки Чикунгунья, оценка перспективных препаратов, вышедших на этапы доклинических (ДКИ) и клинических исследований (КИ), а также анализ перспектив и проблем вывода препаратов на фармацевтический рынок.</p><p>Анализ научной литературы показал, что при разработке вакцин, продолжающейся уже несколько десятилетий, используются как традиционные, так и новейшие технологические платформы. Каждая технологическая платформа имеет свои недостатки и преимущества. На данном этапе около 25 разработок достаточно успешно прошли этап ДКИ и более 7 находятся на разных стадиях КИ. Самыми популярными являются платформа живых аттенуированных вакцин, а также платформа вакцин с использованием векторных конструкций. Препараты, находящиеся в разных фазах КИ, представлены живыми аттенуированными вакцинами (четыре препарата), инактивированным (один препарат), содержащим вирусоподобные частицы (один препарат) и созданным на основе мРНК (один препарат). Для всех семи вакцин была продемонстрирована перекрестная защита от штаммов ЧИКВ разных генотипов или на стадии ДКИ in vivo и/или на стадии КИ in vitro. Исследования продолжаются, что подтверждает наличие не только научного интереса, но также ожиданий системы здравоохранения к выводу на фармацевтический рынок эффективных вакцин против лихорадки Чикунгунья.</p></abstract><trans-abstract xml:lang="en"><p>Chikungunya fever is an acute infectious disease caused by the mosquito-borne Chikungunya virus (CHIKV). In the last decades, cases of the disease have been reported in more than 100 countries; therefore, CHIKV presents a global public health problem. CHIKV genotypes have limited antigenic diversity, and documented reinfection is very rare. Hence, a vaccine could prevent infection and potential disability, as well as reduce the epidemic spread of CHIKV in the population.</p><p>The aim of the study was to review approaches to the development of preventive vaccines against CHIKV, evaluate promising vaccine candidates in preclinical or clinical development stages, and analyse perspectives and challenges of bringing these vaccines to the pharmaceutical market.</p><p>According to the literature reviewed, both traditional and modern platforms are used in the development of CHIKV vaccines, which has been ongoing for several decades. Each platform has its advantages and limitations. The most popular platforms are live attenuated vaccines and vaccines with viral vector constructs. To date, about 25 vaccine candidates have successfully passed through preclinical studies, and more than 7 vaccine candidates have progressed to various phases of clinical studies. The preventive medicinal products that have reached the clinical development stage include 4 live attenuated vaccines, 1 inactivated vaccine, 1 vaccine containing virus-like particles, and 1 mRNA vaccine. All 7 candidates have demonstrated cross-protection against multiple genotypes of CHIKV at the level of either preclinical in vivo studies and/or clinical in vitro studies. The research continues, and this shows that not only the scientific community but also health systems are interested in bringing effective CHIKV vaccines to the pharmaceutical market.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>вирус Чикунгунья</kwd><kwd>эпидемиология</kwd><kwd>вакцины</kwd><kwd>технологические платформы</kwd><kwd>вывод препарата на фармацевтический рынок</kwd></kwd-group><kwd-group xml:lang="en"><kwd>Chikungunya virus</kwd><kwd>epidemiology</kwd><kwd>vaccines</kwd><kwd>technological platforms</kwd><kwd>bringing vaccines to the&#13;
pharmaceutical market</kwd></kwd-group><funding-group><funding-statement xml:lang="ru">Работа выполнена при финансовой поддержке гранта РНФ 22-14-00184.</funding-statement><funding-statement xml:lang="en">The work was supported by the Russian Science Foundation under grant 22-14-00184.</funding-statement></funding-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Okeoma CM, ed. Chikungunya virus. Advances in Biology, Pathogenesis, and Treatment. Springer; 2016. https://doi.org/10.1007/978-3-319-42958-8</mixed-citation><mixed-citation xml:lang="en">Okeoma CM, ed. Chikungunya virus. Advances in Biology, Pathogenesis, and Treatment. Springer; 2016. https://doi.org/10.1007/978-3-319-42958-8</mixed-citation></citation-alternatives></ref><ref id="cit2"><label>2</label><citation-alternatives><mixed-citation xml:lang="ru">Weaver SC, Lecuit M. 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