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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">epidemiology</journal-id><journal-title-group><journal-title xml:lang="ru">Эпидемиология и Вакцинопрофилактика</journal-title><trans-title-group xml:lang="en"><trans-title>Epidemiology and Vaccinal Prevention</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2073-3046</issn><issn pub-type="epub">2619-0494</issn><publisher><publisher-name>«Numicom» LLC</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.31631/2073-3046-2026-25-1-21-32</article-id><article-id custom-type="elpub" pub-id-type="custom">epidemiology-2372</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>ОРИГИНАЛЬНЫЕ СТАТЬИ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>ORIGINAL ARTICLES</subject></subj-group></article-categories><title-group><article-title>Доклиническая оценка иммуногенности и протективной эффективности экспериментальных образцов инактивированной культуральной вакцины против коронавирусной инфекции COVID-19</article-title><trans-title-group xml:lang="en"><trans-title>Preclinical valuation of immunogenicity and effectiveness of inactivated cultural vaccine experimental patterns against coronaviral infection COVID-19</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-1491-6293</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Черникова</surname><given-names>Н. К.</given-names></name><name name-style="western" xml:lang="en"><surname>Cherniкova</surname><given-names>N. K.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Наталья Константиновна Черникова – к. б. н., старший научный сотрудник</p><p>+7 (496) 552-12-06</p><p>г. Сергиев Посад-6</p></bio><bio xml:lang="en"><p>Natalia K. Chernikova – Cand. Sci. (Biol.), Senior Researcher of the Department</p><p>+7 (496) 552-12-06</p></bio><email xlink:type="simple">48cnii@mil.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/0000-0001-9009-4909</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Кутаев</surname><given-names>Д. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Kutaev</surname><given-names>D. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Дмитрий Анатольевич Кутаев – к. б. н., заместитель начальника института по научно-исследовательской работе</p><p>+7 (496) 552-12-06</p><p>г. Сергиев Посад-6</p></bio><bio xml:lang="en"><p>Dmitryi A. Kutaev – Cand. Sci. (Biol.), Deputy Chief of the Institute for scientific and research work</p><p>+7 (496) 552-12-06</p></bio><email xlink:type="simple">48cnii@mil.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/0000-0003-4387-0367</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Рубцов</surname><given-names>В. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Rubtsov</surname><given-names>V. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Владимир Васильевич Рубцов – к. вет. н., научный сотрудник</p><p>+7 (496) 552-12-06</p><p>г. Сергиев Посад-6</p></bio><bio xml:lang="en"><p>Vladimir V. Rubtsov – Cand. Sci. (Vet.), Researcher of the Department</p><p>+7 (496) 552-12-06</p></bio><email xlink:type="simple">48cnii@mil.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Шатохина</surname><given-names>И. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Shatohina</surname><given-names>I. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>г. Сергиев Посад-6</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-0237-9790</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Боярская</surname><given-names>Н. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Boyarskaya</surname><given-names>N. 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(Biol.), Chief of the Directorate</p><p>+7 (496) 552-12-06</p></bio><email xlink:type="simple">48cnii@mil.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/0009-0009-0895-1533</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Нимирская</surname><given-names>С. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Nimirskaya</surname><given-names>S. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Светлана Александровна Нимирская – к. м. н., научный сотрудник</p><p>+7 (496) 552-12-06</p><p>г. Сергиев Посад-6</p></bio><bio xml:lang="en"><p>Svetlana A. Nimirskaya – Cand. Sci. 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(Biol.), Senior Researcher of the Department</p><p>+7 (496) 552-12-06</p></bio><email xlink:type="simple">48cnii@mil.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Кириллова</surname><given-names>С. Л.</given-names></name><name name-style="western" xml:lang="en"><surname>Kirillova</surname><given-names>S. L.</given-names></name></name-alternatives><bio xml:lang="ru"><p>г. Сергиев Посад-6</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Мельников</surname><given-names>С. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Melnikov</surname><given-names>S. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Сергей Алексеевич Мельников – к. б. н., старший научный сотрудник</p><p>+7 (496) 552-12-06</p><p>г. Сергиев Посад-6</p></bio><bio xml:lang="en"><p>Sergey A. Melnikov – Cand. Sci. (Biol.), Senior Researcher of the Department</p><p>+7 (496) 552-12-06</p></bio><email xlink:type="simple">48cnii@mil.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/0000-0002-7985-5516</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Стовба</surname><given-names>Л. Ф.</given-names></name><name name-style="western" xml:lang="en"><surname>Stovba</surname><given-names>L. F.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Людмила Федоровна Стовба – к. б. н., старший научный сотрудник</p><p>+7 (496) 552-12-06</p><p>г. Сергиев Посад-6</p></bio><bio xml:lang="en"><p>Ludmila F. Stovba – Cand. Sci. (Biol.), Senior Researcher of the Department</p><p>+7 (496) 552-12-06</p></bio><email xlink:type="simple">48cnii@mil.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Суровяткин</surname><given-names>А. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Surovyatkin</surname><given-names>A. W.</given-names></name></name-alternatives><bio xml:lang="ru"><p>г. Сергиев Посад-6</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Мищенко</surname><given-names>О. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Mishchenko</surname><given-names>O. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>г. 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E.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Елена Евгеньевна Попадюк – научный сотрудник</p><p>+7 (496) 552-12-06</p><p>г. Сергиев Посад-6</p></bio><bio xml:lang="en"><p>Elena E. Popadyuk – Researcher of the Department</p><p>+7 (496) 552-12-06</p></bio><email xlink:type="simple">48cnii@mil.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/0000-0002-6742-3919</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Борисевич</surname><given-names>С. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Borisevich</surname><given-names>S. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Сергей Владимирович Борисевич – академик РАН, профессор, д. б. н., начальник института</p><p>+7 (496) 552-12-06</p><p>г. Сергиев Посад-6</p></bio><bio xml:lang="en"><p>Sergey V. Borisevich – Academician of RAS, Professor, Dr. Sci. (Biol.), Chief of the Institute</p><p>+7 (496) 552-12-06</p></bio><email xlink:type="simple">48cnii@mil.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/0000-0003-2705-8774</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Кузнецов</surname><given-names>С. Л.</given-names></name><name name-style="western" xml:lang="en"><surname>Kuznetsov</surname><given-names>S. L.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Сергей Леонидович Кузнецов – д. м. н., начальник отдела</p><p>+7 (496) 552-12-06</p><p>г. Москва</p></bio><bio xml:lang="en"><p>Sergey L. Kuznecov – Dr. Sci. 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Iserkapov – Head of the Laboratory for the development of biotechnological projects</p><p>+7 (495) 956-79-37</p></bio><email xlink:type="simple">info@rpharm.ru</email><xref ref-type="aff" rid="aff-3"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0009-0009-3652-0546</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Увицкий</surname><given-names>А. Ю.</given-names></name><name name-style="western" xml:lang="en"><surname>Uvitsky</surname><given-names>A. Yu.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Андрей Юрьевич Увицкий – к. м. н., ведущий биотехнолог</p><p>+7 (495) 956-79-37</p><p>г. Москва</p></bio><bio xml:lang="en"><p>Andrey Yu. Uvitsky – Cand. Sci. (Med.), Leading biotechnologist</p><p>+7 (495) 956-79-37</p></bio><email xlink:type="simple">info@rpharm.ru</email><xref ref-type="aff" rid="aff-3"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0009-0005-9641-3380</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Гузов</surname><given-names>Е. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Guzov</surname><given-names>E. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Евгений Алексеевич Гузов – директор Дирекции по биотехнологическому производству</p><p>+7 (495) 956-79-37</p><p>г. Москва</p></bio><bio xml:lang="en"><p>Evgeny A. Guzov – Director of the Directorate for Biotechnological Production</p><p>+7 (495) 956-79-37</p></bio><email xlink:type="simple">info@rpharm.ru</email><xref ref-type="aff" rid="aff-3"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Федеральное государственное бюджетное учреждение «48 Центральный научно-исследовательский институт» Министерства обороны Российской Федерации</institution><country>Россия</country></aff><aff xml:lang="en"><institution>FSBI «Central Scientific Research Institute No. 48» of the Ministry of Defense of the Russian Federation</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>Управление начальника Войск радиационной, химической и биологической защиты Вооруженных Сил Российской Федерации</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Directorate of the Chief of the Radiation, Chemical, and Biological Defense Troops of the Armed Forces of the Ministry of Defense of the Russian Federation</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-3"><aff xml:lang="ru"><institution>АО «Р-Фарм»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>R-Pharm JSC</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2026</year></pub-date><pub-date pub-type="epub"><day>13</day><month>03</month><year>2026</year></pub-date><volume>25</volume><issue>1</issue><fpage>21</fpage><lpage>32</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Черникова Н.К., Кутаев Д.А., Рубцов В.В., Шатохина И.В., Боярская Н.В., Рождественский Е.В., Нимирская С.А., Хмелев А.Л., Борисевич Г.В., Кириллова С.Л., Мельников С.А., Стовба Л.Ф., Суровяткин А.В., Мищенко О.А., Кузнецов Д.А., Тиско И.М., Подкуйко В.Н., Попадюк Е.Е., Борисевич С.В., Кузнецов С.Л., Колышкин В.М., Игнатьев В.Г., Васильев Ю.М., Исеркапов А.В., Увицкий А.Ю., Гузов Е.А., 2026</copyright-statement><copyright-year>2026</copyright-year><copyright-holder xml:lang="ru">Черникова Н.К., Кутаев Д.А., Рубцов В.В., Шатохина И.В., Боярская Н.В., Рождественский Е.В., Нимирская С.А., Хмелев А.Л., Борисевич Г.В., Кириллова С.Л., Мельников С.А., Стовба Л.Ф., Суровяткин А.В., Мищенко О.А., Кузнецов Д.А., Тиско И.М., Подкуйко В.Н., Попадюк Е.Е., Борисевич С.В., Кузнецов С.Л., Колышкин В.М., Игнатьев В.Г., Васильев Ю.М., Исеркапов А.В., Увицкий А.Ю., Гузов Е.А.</copyright-holder><copyright-holder xml:lang="en">Cherniкova N.K., Kutaev D.A., Rubtsov V.V., Shatohina I.V., Boyarskaya N.V., Rozhdestvenskiy E.V., Nimirskaya S.A., Khmelev A.L., Borisevich G.V., Kirillova S.L., Melnikov S.A., Stovba L.F., Surovyatkin A.W., Mishchenko O.A., Kuznetsov D.A., Tisko M., Podkuyko V.N., Popadyuk E.E., Borisevich S.V., Kuznetsov S.L., Kolyshkin V.M., Ignatiev V.G., Vasiliev Y.M., Iserkapov A.V., Uvitsky A.Y., Guzov E.A.</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.epidemvac.ru/jour/article/view/2372">https://www.epidemvac.ru/jour/article/view/2372</self-uri><abstract><p>Актуальность. Исследования по разработке новых, более совершенных вакцин против COVID-19, как на основе современных технологий, так и традиционных инактивированных, по-прежнему остаются актуальными. В «48 ЦНИИ» Министерства обороны Российской федерации совместно с Филиалом Р-фарм Ярославского завода готовых лекарственных форм была разработана культуральная (в культуре клеток Vero (B)) инактивированная бета-пропиолактоном хроматографически очищенная вакцина от коронавирусной инфекции COVID-19. Цель. Оценить результаты доклинических исследований по иммуногенности и эффективности инактивированной культуральной очищенной вакцины от коронавирусной инфекции COVID-19 в экспериментах на животных. Материалы и методы. Оценили, в том числе в сравнении с Гам-КОВИД-Вак, иммуногенность и протективную активность экспериментальных образцов вакцины с адъювантами гидроокись алюминия и CpG 1018 после двукратной иммунизации сирийских хомячков с интервалом 21 сутки при интраназальном заражении их вирулентным вирусом SARS-CoV-2 в дозе 105 БОЕ/особь. В эксперименте на обезьянах оценили влияние вакцины при двукратной иммунизации на гуморальный – титр вируснейтрализующих антител (ВНА) – и показатели клеточного иммунитета в течение года. Результаты и обсуждение. Выбрана оптимальная доза вакцины – 15 мкг белка и определен состав входящих в нее адъювантов: 500 мкг гидроокиси алюминия и 10 мкг синтетического олигодезоксинуклеотида CpG 1018. Инактивированная сорбированная вакцина от коронавирусной инфекции COVID-19 при двукратном введении с интервалом 21 сутки индуцирует у 80–100 % сирийских хомячков образование вируснейтрализующих антител в титрах 1:20 и более через 21 сутки после завершения цикла иммунизации и характеризуется индексом защиты легких ≥ 3,2 lg на 6-е сутки после инфицирования 105 БОЕ вирулентного вируса (геновариант «Дельта»). При двукратном введении вакцина индуцировала образование специфических вируснейтрализующи антител у макак-резус как к геноварианту «Дельта», так и к геноварианту «Омикрон» вируса SARS-CoV-2, которые сохраняются у 100 % вакцинированных животных в течение 180 суток. К 42-м суткам после завершения вакцинации происходит увеличение цитотоксических Т-лимфоцитов и снижение общих В-лимфоцитов. Выводы. Инактивированная сорбированная очищенная вакцина от коронавирусной инфекции COVID-19 при двукратном введении с интервалом 21 сутки иммуногенна для сирийских хомячков и защищает их от интраназального заражения 105 БОЕ вирулентного вируса. Вакцина обладает иммуногенными свойствами как к геноварианту «Дельта», так и к геноварианту «Омикрон» вируса SARS-CoV-2.</p></abstract><trans-abstract xml:lang="en"><p>Relevance. Research on the development of new, more advanced vaccines against Covid-19, both based on modern technologies and traditional inactivated ones, remains relevant. In the "48 Central Research Institute" of the Ministry of Defense of the Russian Federation, together with the Yaroslavl Factory of ready-made Dosage Forms of JSC R-Pharm, a cultural (based on Vero (B) cell culture) inactivated with beta-propiolactone chromatographically purified vaccine against coronavirus infection Covid-19 was developed. The aim of the work is to evaluate the results of preclinical studies on its immunogenicity and protective effectiveness in animal experiments. Materials and methods. The immunogenicity and protective activity of experimental vaccine samples with adjuvants aluminum hydroxide and CpG 1018 were evaluated, including in comparison with Sputnik V, after double immunization of Syrian hamsters with an interval of 21 days with intranasal infection with the virulent SARS-CoV-2 virus at a dose of 105 Plaqueforming units/individual. In an experiment on monkeys, the effects of the vaccine on double immunization were evaluated: humoral (virus neutralizing antibodies titer) and cellular immunity indicators for 1 year. Results and discussion. The optimal dose of the vaccine was selected – 15 mcg of protein and the composition of the adjuvants included in it was determined: 500 mcg of aluminum hydroxide and 10 mcg of synthetic oligodeoxynucleotide CpG 1018. The inactivated sorbed vaccine against Covid-19 coronavirus infection, when administered twice with an interval of 21 days, induces the formation of viral neutralizing antibodies in 80-100% of Syrian hamsters at titers of 1:20 or more 21 days after the completion of the immunization cycle and is characterized by a lung protection index ≥ 3.2 lg on the 6th day after infection with 105Plaque-forming units of virulent virus (variant “Delta”). The inactivated sorbed vaccine is capable of generating a humoral immune response in rhesus monkeys to both the “Delta” variant and the “Omicron” variant of the SARS-CoV-2 virus. Virus neutralizing antibodies for both variants persists in 100% of vaccinated animals for 180 days after double immunization. By 42 days after the completion of vaccination, there is an increase in cytotoxic T lymphocytes and a decrease in total B lymphocytes. Conclusions. The inactivated sorbed purified vaccine against Covid-19 coronavirus infection, when administered twice, is immunogenic for Syrian hamsters and protects them from intranasal infection with 1•105 Plaqueforming units of virulent virus. The vaccine is capable of generating a specific humoral immune response to both the “Delta” variant and the “Omicron” variant of the SARS-CoV-2 virus. Virus neutralizing antibodies for both variants persists in 100 % of animals for 180 days after double immunization. The effect of immunization on cellular immunity is shown.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>вирус SARS-CoV-2</kwd><kwd>коронавирусная инфекция COVID-19</kwd><kwd>инактивированная культуральная вакцина</kwd><kwd>иммуногенность</kwd><kwd>протективные свойства</kwd><kwd>сирийские хомячки</kwd><kwd>обезьяны макака резус</kwd><kwd>интраназальное заражение</kwd></kwd-group><kwd-group xml:lang="en"><kwd>virus SARS-CoV-2</kwd><kwd>coronaviral infection COVID-19</kwd><kwd>Inactivated cultural vaccine</kwd><kwd>immunogenicity</kwd><kwd>protective properties</kwd><kwd>syrial hamsters</kwd><kwd>monkeys macaca rhesus</kwd><kwd>intranasal challenge</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Горенков Д.В., Хантимирова Л.М., Шевцов В.А., и др. Вспышка нового инфекционного заболевания Covid-19: β-коронавирусы как угроза глобальному здравоохранению. Биопрепараты. 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