biopreparatБИОпрепараты. Профилактика, диагностика, лечениеBiological Products. Prevention, Diagnosis, Treatment2221-996X2619-1156Scientific Centre for Expert Evaluation of Medicinal Products10.30895/2221-996X-2024-24-3-255-269biopreparat-592Research ArticleТЕМА НОМЕРА: РАЗРАБОТКА ДИАГНОСТИЧЕСКИХ, ЛЕЧЕБНЫХ И ПРОФИЛАКТИЧЕСКИХ ПРЕПАРАТОВ ПРОТИВОВИРУСНОГО ДЕЙСТВИЯISSUE TOPIC: DEVELOPMENT OF MEDICINAL PRODUCTS FOR DIAGNOSIS, TREATMENT, AND PREVENTION OF VIRAL INFECTIONSПрофилактика респираторно-синцитиальной вирусной инфекции: современное состояние и перспективы разработки вакцинProphylaxis of respiratory syncytial virus infection: current status and prospects for vaccine developmenthttps://orcid.org/0000-0002-3241-1053КоровкинА. С.KorovkinA. S.

Коровкин Алексей Сергеевич, канд. мед. наук

Петровский б-р, д. 8, стр. 2, Москва, 127051

Alexey S. Korovkin, Cand. Sci. (Med.)

8/2 Petrovsky Blvd, Moscow 127051

korovkinas@expmed.ruhttps://orcid.org/0000-0003-0940-8080ГоренковД. В.GorenkovD. V.

Горенков Дмитрий Витальевич

Петровский б-р, д. 8, стр. 2, Москва, 127051

Dmitry V. Gorenkov

8/2 Petrovsky Blvd, Moscow 127051

gorenkov@expmed.ruhttps://orcid.org/0000-0002-8097-2680ВолгинА. Р.VolginA. R.

Волгин Андрей Рудольфович, канд. мед. наук

Петровский б-р, д. 8, стр. 2, Москва, 127051

Andrey R. Volgin, Cand. Sci. (Med.)

8/2 Petrovsky Blvd, Moscow 127051

volgin@expmed.ruФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииРоссияScientific Centre for Expert Evaluation of Medicinal ProductsRussian Federation202403102024243Разработка диагностических, лечебных и профилактических препаратов противовирусного действия255269Copyright © Коровкин А.С., Горенков Д.В., Волгин А.Р., 20242024Коровкин А.С., Горенков Д.В., Волгин А.Р.Korovkin A.S., Gorenkov D.V., Volgin A.R.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/592ВВЕДЕНИЕ

ВВЕДЕНИЕ. Респираторно-синцитиальный вирус (РСВ) является одним из самых распространенных типичных возбудителей ОРВИ и инфекций нижних дыхательных путей у детей и взрослых. Уже долгое время применяются препараты моноклональных антител для проведения профилактической пассивной иммунизации недоношенных детей с бронхолегочной дисплазией, однако недавно были лицензированы вакцины для профилактической вакцинации лиц старшего возраста с наличием различных факторов риска тяжелого течения РСВ-инфекции, в первую очередь таких, как хронические заболевания сердечно-сосудистой системы, дыхательной системы и сахарный диабет.

ЦЕЛЬ

ЦЕЛЬ. Обзор состояния разработки вакцин для активной иммунизации против РСВ-инфекции, включающий эпидемиологическое обоснование разработки, результаты клинических исследований зарегистрированных вакцин, рекомендации по вакцинации населения и обзор перспективных разработок вакцин для профилактики РСВ-инфекции.

ОБСУЖДЕНИЕ

ОБСУЖДЕНИЕ. Создать вакцину для профилактики РСВ-инфекции долгое время не удавалось в первую очередь из-за особенностей иммунопатогенеза РСВ-инфекции и генетической гипервариабельности РСВ. Зарубежным исследователям удалось идентифицировать консервативную мишень для нейтрализующих антител, способную индуцировать специфический иммунитет. Такой мишенью является стабилизированный префьюжн (pre-F) капсидный белок РСВ, который при изменении конформационного состояния до F-белка отвечает за проникновение вируса в клетку. На основе рекомбинантных pre-F-белков были созданы субъединичные вакцины, успешно прошедшие ряд клинических исследований (КИ) и одобренные для иммунизации лиц старшего возраста. Также одна из вакцин рекомендована для применения во время беременности с целью профилактики РСВ-инфекции у новорожденных и младенцев. В настоящее время реализуются программы разработки новых РСВ-вакцин на основе мРНК и нереплицирующихся аттенуированных гриппозных векторов. В результате проведенного исследования были изучены и суммированы показатели эффективности и безопасности двух РСВ-вакцин, одобренных к применению в различных странах мира. Оба препарата обладают удовлетворительным профилем безопасности и сопоставимыми показателями профилактической эффективности.

ЗАКЛЮЧЕНИЕ

ЗАКЛЮЧЕНИЕ. Предрегистрационные КИ новых РСВ-вакцин, в том числе разрабатываемых в Российской Федерации, должны включать оценку профилактической эффективности в целевых группах пациентов. При регистрации в Российской Федерации вакцин, уже получивших одобрение ведущих зарубежных регуляторных органов, потребуется проведение ограниченных связующих исследований для подтверждения иммуногенности и безопасности препаратов.

INTRODUCTION

INTRODUCTION. Respiratory syncytial virus (RSV) is one of the most widespread pathogens that typically cause acute upper and lower respiratory tract infections in children and adults. Monoclonal antibody products have long been used for passive immunoprophylaxis in premature infants with bronchopulmonary dysplasia. However, vaccines have recently been licensed for the prophylactic immunisation of older adults with various risk factors for severe RSV infection (primarily, chronic cardiovascular and respiratory diseases and diabetes mellitus).

AIM

AIM. This study aimed to review the current status of the development of vaccines for active immunisation against RSV infection, including the epidemiological rationale for their development, clinical trial results for licensed vaccines, recommendations for vaccination, and promising pipeline vaccines for RSV prevention.

DISCUSSION

DISCUSSION. Initially hindered by the unique immunopathogenesis of RSV infection and the genetic hypervariability of RSV for a long time, attempts to develop an RSV vaccine succeeded when international researchers managed to identify a conservative neutralising antibody target capable of inducing specific immunity against RSV. This target, the RSV capsid protein stabilised in its prefusion (pre-F) conformation, can mediate viral entry into the cell following a conformational change. Several subunit vaccines based on recombinant pre-F proteins have successfully passed clinical trials and have been approved for the immunisation of older adults. In addition, one of these vaccines has been recommended for use during pregnancy to prevent RSV infection in newborns and infants. Currently, programmes are being implemented to develop novel RSV vaccines based on messenger RNA (mRNA) and non-replicating attenuated influenza vectors. This article examines and summarises the efficacy and safety parameters of two RSV vaccines approved in multiple countries around the world. Both vaccines have satisfactory safety profiles and comparable prophylactic efficacy parameters.

CONCLUSIONS

CONCLUSIONS. Prelicensure clinical trials of novel RSV vaccines, including those being developed in the Russian Federation, should include prophylactic efficacy assessments in target patient populations. For vaccines approved by leading international regulators, clinical trials required for approval in the Russian Federation will be limited to bridging studies confirming the immunogenicity and safety of the vaccines.

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