biopreparatБИОпрепараты. Профилактика, диагностика, лечениеBiological Products. Prevention, Diagnosis, Treatment2221-996X2619-1156Scientific Centre for Expert Evaluation of Medicinal Products10.30895/2221-996X-2026-26-3-324-335biopreparat-820Research ArticleВАКЦИНОПРОФИЛАКТИКА ИНФЕКЦИОННЫХ ЗАБОЛЕВАНИЙVACCINE PROPHYLAXIS AGAINST INFECTIOUS DISEASESВакцины для профилактики хантавирусных лихорадок: обзор результатов и перспектив разработокVaccines for the prevention of hantavirus fevers: An overview of results and development prospectshttps://orcid.org/0000-0003-2117-597XТеодоровичР. Д.TeodorovichR. D.

Теодорович Ростислав Дмитриевич

поселок Института Полиомиелита, д. 8, корп. 1, вн. тер. г. муниципальный округ Филимонковский, Москва, 108819

Rostislav D. Theodorovich

8/1 Village of Institute of Poliomyelitis, Settlement “Moskovskiy”, Moscow, 108819

teodorovich_rd@chumakovs.suhttps://orcid.org/0000-0002-6656-1682ДзагуроваТ. К.DzagurovaT. K.

Дзагурова Тамара Казбековна, д-р мед. наук

поселок Института Полиомиелита, д. 8, корп. 1, вн. тер. г. муниципальный округ Филимонковский, Москва, 108819

Tamara K. Dzagurova, Dr. Sci. (Med.)

8/1 Village of Institute of Poliomyelitis, Settlement “Moskovskiy”, Moscow, 108819

dzagurova_tk@chumakovs.suhttps://orcid.org/0000-0001-9934-699XКурашоваС. С.KurashovaS. S.

Курашова Светлана Сергеевна, канд. мед. наук

поселок Института Полиомиелита, д. 8, корп. 1, вн. тер. г. муниципальный округ Филимонковский, Москва, 108819

Svetlana S. Kurashova, Cand. Sci. (Med.)

8/1 Village of Institute of Poliomyelitis, Settlement “Moskovskiy”, Moscow, 108819

kurashova_ss@chumakovs.suhttps://orcid.org/0000-0003-3642-6444ЕгороваМ. С.EgorovaM. S.

Егорова Мария Сергеевна, канд. биол. наук

поселок Института Полиомиелита, д. 8, корп. 1, вн. тер. г. муниципальный округ Филимонковский, Москва, 108819

Maria S. Egorova, Cand. Sci. (Biol.).

8/1 Village of Institute of Poliomyelitis, Settlement “Moskovskiy”, Moscow, 108819

egorova_ms@chumakovs.suhttps://orcid.org/0000-0002-9038-7717КоротинаН. А.KorotinaN. A.

Коротина Наталья Александровна

поселок Института Полиомиелита, д. 8, корп. 1, вн. тер. г. муниципальный округ Филимонковский, Москва, 108819

Natalia A. Korotina

8/1 Village of Institute of Poliomyelitis, Settlement “Moskovskiy”, Moscow, 108819

korotina_na@chumakovs.suhttps://orcid.org/0000-0003-2198-7521БаловневаМ. В.BalovnevaM. V.

Баловнева Мария Владимировна, канд. биол. наук

поселок Института Полиомиелита, д. 8, корп. 1, вн. тер. г. муниципальный округ Филимонковский, Москва, 108819

Mariya V. Balovneva, Cand. Sci. (Biol.)

8/1 Village of Institute of Poliomyelitis, Settlement “Moskovskiy”, Moscow, 108819

balovneva_mv@chumakovs.suhttps://orcid.org/0000-0001-6130-4145ИшмухаметовА. А.IshmukhametovA. A.

Ишмухаметов Айдар Айратович, д-р мед. наук, проф., академик РАН

поселок Института Полиомиелита, д. 8, корп. 1, вн. тер. г. муниципальный округ Филимонковский, Москва, 108819;

ул. Трубецкая, д. 8, стр. 2, Москва, 119991

Aydar A. Ishmukhametov, Dr. Sci. (Med.), Prof., Academician of RAS

8/1 Village of Institute of Poliomyelitis, Settlement “Moskovskiy”, Moscow 108819;

8/2 Trubetskaya St., Moscow, 119991

ishmukhametov_aa@chumakovs.suФедеральное государственное автономное научное учреждение «Федеральный научный центр исследований и разработки иммунобиологических препаратов им. М.П. Чумакова РАН» (Институт полиомиелита)РоссияChumakov Federal Scientific Centre for Research and Development of Immune-and-Biological Products (Institute of Poliomyelitis)Russian FederationФедеральное государственное автономное научное учреждение «Федеральный научный центр исследований и разработки иммунобиологических препаратов им. М.П. Чумакова РАН» (Институт полиомиелита); Федеральное государственное автономное образовательное учреждение высшего образования «Первый Московский государственный медицинский университет имени И.М. Сеченова» Министерства здравоохранения Российской Федерации (Сеченовский Университет)РоссияChumakov Federal Scientific Centre for Research and Development of Immune-and-Biological Products (Institute of Poliomyelitis); I.M. Sechenov First Moscow State Medical University (Sechenov University)Russian Federation202605102026263324335Copyright © Теодорович Р.Д., Дзагурова Т.К., Курашова С.С., Егорова М.С., Коротина Н.А., Баловнева М.В., Ишмухаметов А.А., 20262026Теодорович Р.Д., Дзагурова Т.К., Курашова С.С., Егорова М.С., Коротина Н.А., Баловнева М.В., Ишмухаметов А.А.Teodorovich R.D., Dzagurova T.K., Kurashova S.S., Egorova M.S., Korotina N.A., Balovneva M.V., 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.biopreparations.ru/jour/article/view/820ВВЕДЕНИЕ

ВВЕДЕНИЕ. Хантавирусные лихорадки, регистрируемые как геморрагическая лихорадка с почечным синдромом (ГЛПС) на Евроазиатском и хантавирусный пульмональный синдром (ХПС) на Американском континентах, представляют собой природно-очаговые болезни с широким диапазоном клинических проявлений. Возбудители — представители рода Orthohantavirus, резервуаром которых в природе являются грызуны различных видов. Этиотропной терапии хантавирусных лихорадок в настоящее время не существует. Специфическая профилактика в форме вакцинации проводится только в КНДР, Республике Корее и КНР. Важной задачей является обеспечение российского и европейского рынка актуальной вакциной для профилактики ГЛПС. Противохантавирусная вакцина должна разрабатываться как с учетом подходов, доказавших временем свою эффективность, так и опыта современных разработок.

ЦЕЛЬ

ЦЕЛЬ. Анализ применения существующих хантавирусных и особенностей разрабатываемых вакцин, а также оценка перспектив создания вакцин для профилактики ГЛПС в Российской Федерации.

ОБСУЖДЕНИЕ

ОБСУЖДЕНИЕ. Все коммерчески доступные вакцинные препараты являются инактивированными цельновирионными вакцинами на основе вирусов Хантаан и Сеул. Эффективность этих препаратов различается, но отмечается существенное снижение заболеваемости в регионах с массовой вакцинацией и низкая частота побочных явлений. В России разработаны несколько инактивированных цельновирионных вакцин на основе актуальных штаммов ортохантавирусов. Некоторые из разработок успешно прошли доклинические испытания. Спектр разрабатываемых хантавирусных вакцинных препаратов представлен субъединичными вакцинами, вакцинами на основе вирусоподобных частиц и вирусных векторов, ДНК- и мРНК-вакцин. В качестве основных иммуногенов используются поверхностные гликопротеины Gn и Gc хантавирусов. Наиболее близко к внедрению в медицинскую практику оказались ДНК-вакцины на основе вирусов Пуумала и Хантаан, прошедшие клинические исследования (фаза I).

ЗАКЛЮЧЕНИЕ

ЗАКЛЮЧЕНИЕ. Ни один вакцинный препарат для профилактики хантавирусных инфекций, разработанный на основе вирусоподобных частиц, вирусных векторов, нуклеиновых кислот, не прошел полного цикла клинических испытаний и не лицензирован в мире. Напротив, отлаженные традиционные технологии изготовления инактивированных вакцин и их доказанная временем эффективность обусловливают реальные перспективы их практического применения в России и других европейских странах.

 

 

INTRODUCTION

INTRODUCTION. Hantavirus fevers, known as hemorrhagic fever with renal syndrome (HFRS) in Eurasia and hantavirus pulmonary syndrome (HPS) in the Americas, are natural focal diseases with a wide range of clinical manifestations. The causative agents are members of the genus Orthohantavirus, whose natural reservoirs are rodents of various species. There is currently no etiotropic therapy for these diseases. Specific prophylaxis through vaccination is available only in the DPRK, the Republic of Korea, and the People's Republic of China. An important objective is to provide the Russian and European markets with a relevant vaccine for HFRS prevention. Such a vaccine should be developed based on both time-proven approaches and the experience of modern developments.

AIM

AIM. Analysis of the use of existing hantavirus vaccines and the specific features of vaccines under development, as well as assessment of the prospects for creating vaccines for HFRS prevention in the Russian Federation.

DISCUSSION

DISCUSSION. All commercially available vaccine preparations are inactivated whole-virion vaccines based on the Hantaan and Seoul viruses. The effectiveness of these preparations varies, but a significant reduction in the incidence rate in regions with mass vaccination and a low incidence of adverse events have been noted. Several inactivated whole-virion vaccines based on relevant orthohantavirus strains have been developed in Russia. Some of these developments have successfully completed preclinical studies. The spectrum of hantavirus vaccine preparations under development includes subunit vaccines, vaccines based on virus-like particles (VLPs) and viral vectors, DNA vaccines, and mRNA vaccines. The primary immunogens are the surface glycoproteins Gn and Gc of hantaviruses. The closest to implementation into clinical practice are the DNA vaccines based on the Puumala and Hantaan viruses, which have undergone clinical trials (phase I).

CONCLUSIONS

CONCLUSIONS. No vaccine for the prevention of hantavirus infections developed using virus-like particles (VLPs), viral vectors, or nucleic acids (DNA or mRNA) has undergone a full cycle of clinical trials or been licensed worldwide. On the contrary, well-established traditional technologies for manufacturing inactivated vaccines and their time-proven effectiveness provide a basis for their real prospects of practical application in the Russian Federation and other European countries.

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