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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">antibiotics</journal-id><journal-title-group><journal-title xml:lang="ru">Антибиотики и Химиотерапия</journal-title><trans-title-group xml:lang="en"><trans-title>Antibiot Khimioter = Antibiotics and Chemotherapy</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">0235-2990</issn><publisher><publisher-name>ООО «Издательство ОКИ»</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.37489/0235-2990-2024-69-7-8-44-52.</article-id><article-id custom-type="elpub" pub-id-type="custom">antibiotics-1161</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>КЛИНИЧЕСКИЕ ИССЛЕДОВАНИЯ И ПРАКТИКА</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>GUIDELINES FOR PRACTITIONERS</subject></subj-group></article-categories><title-group><article-title>Эффективность, иммуногенность и безопасность комбинированной векторной вакцины Гам-КОВИД-Вак у больных ревматическими заболеваниями</article-title><trans-title-group xml:lang="en"><trans-title>Efficacy, Immunogenicity, and Safety of the Combined Vector Vaccine Gam-COVID-Vac in Patients with Rheumatic Diseases</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-1040-313X</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Куликов</surname><given-names>А. Н.</given-names></name><name name-style="western" xml:lang="en"><surname>Kulikov</surname><given-names>A. N.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Куликов Александр Николаевич — младший научный сотрудник лаборатории коморбидных инфекций и вакцинопрофилактики</p><p>ResearcherID: ACH-6623-2022</p><p>Scopus Author ID: 57207452071</p><p>Москва</p></bio><bio xml:lang="en"><p>Aleksandr N. Kulikov — Junior Researcher, Laboratory of Comorbid Infections and Vaccine Prevention</p><p>ResearcherID: ACH-6623-2022</p><p>Moscow</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/0000-0003-4327-6720</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Муравьева</surname><given-names>Н. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Muravyeva</surname><given-names>N. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Муравьева Наталья Валерьевна — к. м. н., старший научный сотрудник лаборатории коморбидных инфекций и вакцинопрофилактики</p><p>ResearcherID: AAF-4853-2021</p><p>Scopus Author ID: 57210263706</p><p>Москва</p></bio><bio xml:lang="en"><p>Natalia V. Muravyeva — Ph. D, in Medicine, Senior Researcher, Laboratory of Comorbid Infections and Vaccine Prevention</p><p>ResearcherID: AAF-4853-2021</p><p>Moscow</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/0000-0001-7091-2054</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Белов</surname><given-names>Б. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Belov</surname><given-names>B. S.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Белов Борис Сергеевич — д. м. н., заведующий лабораторией коморбидных инфекций и вакцинопрофилактики</p><p>ResearcherID: ABD-2219-2020</p><p>Scopus Author ID: 7004592537</p><p>Москва</p></bio><bio xml:lang="en"><p>Boris S. Belov — D. Sc. in Medicine, Head of the Laboratory of Comorbid Infections and Vaccine Prevention</p><p>ResearcherID: ABD-2219-2020</p><p>Moscow</p></bio><email xlink:type="simple">belovbor@yandex.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/0000-0002-0928-3911</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Гриднева</surname><given-names>Г. И.</given-names></name><name name-style="western" xml:lang="en"><surname>Gridneva</surname><given-names>G. I.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Гриднева Галина Игоревна — к. м. н., научный сотрудник лаборатории коморбидных инфекций и вакцинопрофилактики</p><p>ResearcherID: AFN-9929-2022</p><p>Scopus Author ID: 56381565500</p><p>Москва</p></bio><bio xml:lang="en"><p>Galina I. Gridneva — Ph. D, in Medicine, Researcher, Laboratory of Comorbid Infections and Vaccine Prevention</p><p>ResearcherID: AFN-9929-2022</p><p>Moscow</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/0000-0002-1833-5357</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Аронова</surname><given-names>Е. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Aronova</surname><given-names>E. S.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Аронова Евгения Сергеевна — к. м. н., научный сотрудник лаборатории коморбидных инфекций и вакцинопрофилактики, заведующий антицитокиновым центром с дневным стационаром</p><p>ResearherIID: AAD-1849-2019</p><p>Scopus Author ID: 55913403200</p><p>Москва</p></bio><bio xml:lang="en"><p>Evgeniya S. Aronova — Ph. D, in Medicine, Researcher, Laboratory of Comorbid Infections and Vaccine Prevention, Head of the Anti-Cytokine Center with Day Hospital</p><p>ResearherID: AAD-1849-2019</p><p>Moscow</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/0000-0002-4829-5210</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Верижникова</surname><given-names>Ж. Г.</given-names></name><name name-style="western" xml:lang="en"><surname>Verizhnikova</surname><given-names>Z. G.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Верижникова Жанна Григорьевна — младший научный сотрудник лаборатории иммунологии и молекулярной биологии ревматических заболеваний</p><p>ResearcherID: ACU-5575-2022</p><p>Scopus Author ID: 57195267778</p><p>Москва</p></bio><bio xml:lang="en"><p>Zhanna G. Verizhnikova — Junior Researcher, Laboratory of Immunology and Molecular Biology of Rheumatic Diseases</p><p>ResearcherID: ACU-5575-2022</p><p>Moscow</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/0000-0001-7501-9185</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Самаркина</surname><given-names>Е. Ю.</given-names></name><name name-style="western" xml:lang="en"><surname>Samarkina</surname><given-names>E. Yu.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Самаркина Елена Юрьевна — младший научный сотрудник лаборатории иммунологии и молекулярной биологии ревматических заболеваний</p><p>ResearcherID: AAF-6946-2021</p><p>Scopus Author ID: 55913670900</p><p>Москва</p></bio><bio xml:lang="en"><p>Samarkina Elena Yurievna — Junior Researcher, Laboratory of Immunology and Molecular Biology of Rheumatic Diseases</p><p>ResearcherID: AAF-6946-2021</p><p>Moscow</p></bio><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>ФГБНУ «Научно-исследовательский институт ревматологии им. В. А. Насоновой»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>V. A. Nasonova Research Institute of Rheumatology</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2024</year></pub-date><pub-date pub-type="epub"><day>21</day><month>11</month><year>2024</year></pub-date><volume>69</volume><issue>7-8</issue><fpage>44</fpage><lpage>52</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Куликов А.Н., Муравьева Н.В., Белов Б.С., Гриднева Г.И., Аронова Е.С., Верижникова Ж.Г., Самаркина Е.Ю., 2024</copyright-statement><copyright-year>2024</copyright-year><copyright-holder xml:lang="ru">Куликов А.Н., Муравьева Н.В., Белов Б.С., Гриднева Г.И., Аронова Е.С., Верижникова Ж.Г., Самаркина Е.Ю.</copyright-holder><copyright-holder xml:lang="en">Kulikov A.N., Muravyeva N.V., Belov B.S., Gridneva G.I., Aronova E.S., Verizhnikova Z.G., Samarkina E.Y.</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.antibiotics-chemotherapy.ru/jour/article/view/1161">https://www.antibiotics-chemotherapy.ru/jour/article/view/1161</self-uri><abstract><p>Цель исследования — оценка эффективности, иммуногенности и безопасности комбинированной векторной вакцины Гам-КОВИД-Вак и определение факторов риска развития нежелательных явлений (НЯ) у больных ревматическими заболеваниями (РЗ). Пациенты и методы. Настоящее исследование состояло из ретроспективной и проспективной части, в которые вошли 295 и 42 больных РЗ, 113 и 57 лиц без этих заболеваний, соответственно.</p><p>Информация об эффективности, которую оценивали по частоте подтвержденных методом полимеразной цепной реакции случаев COVID-19 в период от 31 до 365 день после вакцинации, получена от 291 пациента с РЗ и 146 участников контрольной группы. Концентрацию антител к SARS-CoV-2 оценивали методом иммуноферментного анализа у проспективной когорты через 1, 3, 6 и 12 мес. после введения второго компонента вакцины. Безопасность изучали у всех участников по частоте НЯ и обострения основного РЗ.</p><sec><title>Результаты</title><p>Результаты. После вакцинации зафиксировано 29 (9,97%) случаев COVID-19 у больных РЗ, в 27 из них отмечено лёгкое течение, а в 2 — потребовалась госпитализация, все случаи закончились выздоровлением. Предшествующая иммунизации терапия ритуксимабом увеличивала риск развития COVID-19 в 2,3 раза. У пациентов с РЗ отмечено значимое нарастание концентрации поствакцинальных антител через 1, 3 и 12 мес. после полной иммунизации (p&lt;0,006 для всех точек). НЯ отсутствовали у 40,72% больных РЗ и 24,71% лиц контрольной группы, соответственно, p&lt;0,001. Частота поствакцинальных обострений РЗ составила 0,6%. Риск развития местных и системных НЯ (в зависимости от вводимого компонента) повышен у женщин, пациентов моложе 60 лет, при длительности РЗ менее 10 лет и на фоне терапии метотрексатом (p&lt;0,016 для всех случаев).</p></sec><sec><title>Заключение</title><p>Заключение. Согласно полученным данным, применение Гам-КОВИД-Вак у больных РЗ характеризуется хорошей эффективностью, достаточной иммуногенностью и безопасностью.</p></sec></abstract><trans-abstract xml:lang="en"><p>The aim of the study is to assess the efficacy, immunogenicity, and safety of the combined vector vaccine Gam-COVID-Vac and to determine the risk factors for the development of adverse events (AEs) in patients with rheumatic diseases (RD).</p><sec><title>Patients and methods</title><p>Patients and methods. The present study consisted of a retrospective and prospective parts, which included 295 and 42 patients with RD, as well as 113 and 57 healthy controls, respectively. Information about efficacy was obtained from 291 patients with RD and 146 controls, which was assessed by the incidence of PCR-confirmed COVID-19 cases from 31 to 365 days after vaccination. The concentration of antibodies to SARS-CoV-2 was assessed by enzyme immunoassay in a prospective cohort at 1, 3, 6, and 12 months after administration of the second component of the vaccine. Safety was studied in all participants based on the incidence of AEs and exacerbation of underlying RD.</p></sec><sec><title>Results</title><p>Results. After vaccination, 29 (9.97%) cases of COVID-19 were recorded in patients with RD, 27 of them were mild, and 2 required hospitalization, all cases ended in recovery. Treatment with rituximab before vaccination increased the risk of developing COVID-19 by 2.3 times. A sig-nificant increase in antibody titers was observed after 1, 3, and 12 months after full immunization in patients with RD (P&lt;0.006 for all points). AEs were absent in 40.72% of patients with RD and 24.71% healthy controls, P&lt;0.001. Exacerbations of RD were registered in 2 (0.6%) cases. The risk of developing local and systemic AEs (depending on the administered component) was increased in women, patients under the age of 60 year, with a duration of RD less than 10 years, and methotrexate therapy (P&lt;0.016 for all cases).</p></sec><sec><title>Conclusions</title><p>Conclusions. According to the data obtained, the use of Gam-COVID-Vac in patients with RD is characterized by good efficacy, sufficient immunogenicity, and safety.</p></sec></trans-abstract><kwd-group xml:lang="ru"><kwd>ревматические заболевания</kwd><kwd>вакцинация</kwd><kwd>COVID-19</kwd><kwd>Гам-КОВИД-Вак</kwd><kwd>эффективность</kwd><kwd>иммуногенность</kwd><kwd>безопасность</kwd><kwd>нежелательные явления</kwd></kwd-group><kwd-group xml:lang="en"><kwd>rheumatic diseases</kwd><kwd>vaccination</kwd><kwd>COVID-19</kwd><kwd>Gam-COVID-Vac</kwd><kwd>effectiveness</kwd><kwd>immunogenicity</kwd><kwd>safety</kwd><kwd>adverse events</kwd></kwd-group><funding-group><funding-statement xml:lang="ru">Исследование выполнено в рамках научно-исследовательской работы ФГБНУ «Научно-исследовательский институт ревматологии им. В. А. Насоновой», № государственного задания 1021051503137-7.</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">Wu Z., McGoogan J.M. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020; 323 (13): 1239–1242. doi: 10.1001/jama.2020.2648.</mixed-citation><mixed-citation xml:lang="en">Wu Z., McGoogan J.M. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72314 Cases From the Chinese Center for Disease Control and Prevention. 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