zdorПроблемы здоровья и экологииHealth and Ecology Issues2220-09672708-6011Gomel State Medical University10.51523/2708-6011.2024-21-4-03zdor-2783Research ArticleКЛИНИЧЕСКАЯ МЕДИЦИНАCLINICAL MEDICINEИммунологическая эффективность бустерной вакцины «Soberana Plus» (FINLAY-FR-1A)Immunological effectiveness of the booster Soberana Plus vaccine (FINLAY-FR-1A)https://orcid.org/0000-0003-3461-3246КорсакЕ. С.KorsakK. S.

Корсак Екатерина Сергеевна, ассистент кафедры эпидемиологии и доказательной медицины

Гомель

Katsiaryna S. Korsak, Assistant Lecturer at the Department of Epidemiology and Evidence-based Medicine

Gomel

katsiaryna.korsak@gsmu.byhttps://orcid.org/0000-0002-9435-6109ВоропаевЕ. В.VoropaevE. V.

Воропаев Евгений Викторович, к.м.н., доцент, проректор по научной работе

Гомель

Evgenii V. Voropaev, Candidate of Medical Sciences, Associate Professor, Vice-rector for Scientific Work

Gomel

voropaev.evgenii@gsmu.byhttps://orcid.org/0000-0002-1931-4224ОсипкинаО. В.OsipkinaO. V.

Осипкина Ольга Викторовна, заведующий научноисследовательской лабораторией

Гомель

Olga V. Osipkina, Head of the Research Laboratory

Gomel

olga.osipkina@gsmu.byhttps://orcid.org/0000-0001-9148-487XКовалевА. А.KovalevA. A.

Ковалёв Алексей Алексеевич, старший преподаватель кафедры медицинской и биологической физики, инженер-программист центра науки, медицинской информации и клинических испытаний

Гомель

Alexey A. Kovalev, Senior Lecturer at the Department of Medical and Biological Physics, Software Engineer at the Center for Science, Medical Information and Clinical Trials

Gomel

aleksey.kovalev@gsmu.byhttps://orcid.org/0000-0003-0483-7329СтомаИ. О.StomaI. O.

Стома Игорь Олегович, д.м.н., профессор, ректор

Гомель

Igor O. Stoma, Doctor of Medical Sciences, Professor, Rector

Gomel

igor.stoma@gsmu.byГомельский государственный медицинский университетGomel State Medical University2024160120252142636Copyright © Корсак Е.С., Воропаев Е.В., Осипкина О.В., Ковалев А.А., Стома И.О., 20252025Корсак Е.С., Воропаев Е.В., Осипкина О.В., Ковалев А.А., Стома И.О.Korsak K.S., Voropaev E.V., Osipkina O.V., Kovalev A.A., Stoma I.O.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://journal.gsmu.by/jour/article/view/2783Цель исследования

Цель исследования. Оценить иммуногенность бустерной дозы вакцины «Soberana Plus» (FINLAY-FR-1A) у взрослых, ранее вакцинированных против COVID-19.

Методы и методы

Методы и методы. В исследовании приняли участие 98 человек. Иммуногенность вакцины «Soberana Plus» (FINLAY-FR-1A) изучалась при помощи измерения концентрации IgG к SARS-CoV-2 иммуноферментным методом (ИФА) до вакцинации, через 42 дня, 90 дней и 180 дней после введения вакцины «Soberana Plus» (FINLAY-FR-1A).

Результаты

Результаты. Участники исследования были разделены на группы по типу вакцины, которая использовалась в качестве первичной иммунизации: 1) «Спутник V» (Gam-COVID-Vac) / «Спутник Лайт»; 2) «Sinopharm» (BBIBP-CorV), 3) «Sinopharm» (BBIBP-CorV) + «Спутник V» (Gam-COVID-Vac) / «Спутник Лайт». Наиболее высокий уровень IgG наблюдался через 90 дней после введения бустерной дозы (p < 0,001), через 180 дней после введения «Soberana Plus» (FINLAY-FR-1A) уровень IgG значимо снизился по сравнению с уровнем, который был зафиксирован через 90 дней (р = 0,02), однако остался выше уровня IgG до вакцинации (р < 0,001). Через 90 дней наблюдения уровень IgG был выше в группе ранее привитых вакцинами «Спутник V» (Gam-COVID-Vac) / «Спутник Лайт» + «Sinopharm» (BBIBP-CorV), однако в этой группе отмечался более высокий уровень IgG до введения вакцины «Soberana Plus» (FINLAY-FR-1A). Через 42 дня после вакцинации наиболее высокий уровень IgG был у участников группы «старше 45 лет», через 180 дней более высокий уровень IgG был в группе «старше 45 лет» в сравнении с уровнем IgG в группе «25–45 лет» (р = 0,048).

Заключение

Заключение. Вакцина «Soberana Plus» (FINLAY-FR-1A) обладает достаточной иммуногенностью. Наиболее высокий уровень IgG к SARS-CoV-2 отмечен на 90-й день (р < 0,001), через 180 дней он остался выше уровня IgG до вакцинации (р < 0,001). Через 90 дней участники, первично иммунизированные вакциной «Sinopharm» (BBIBP-CorV), имели более низкий уровень антител по сравнению с участниками, первично иммунизированными «Sinopharm» (BBIBP-CorV) + «Спутник V» (Gam-COVID-Vac) / «Спутник Лайт» (р = 0,042).

Objective

Objective. To assess the efficacy of immunogenicity of the Soberana Plus (FINLAY-FR-1A) vaccine in adults previously vaccinated against COVID-19.

Materials and methods

Materials and methods. A total of 98 participants participated in the study. The immunogenicity of the Soberana Plus (FINLAY-FR-1A) vaccine was studied by measuring IgG concentration to SARS-CoV-2 by enzyme-linked immunosorbent assay (ELISA) at 4 study sites: day 0, in 42 days, 90 days and 180 days after the Soberana Plus (FINLAY-FR-1A) administration.

Results

Results. Participants of the study were divided into groups based on their primary immunization: 1) Sputnik V (Gam-COVID-Vac) / Sputnik Light; 2) Sinopharm (BBIBP-CorV); 3) Sinopharm (BBIBP-CorV) + Sputnik V (Gam-COVIDVac) / Sputnik Light. The highest IgG level was observed in 90 days after administration of booster dose (p< 0,001). At the “90 day” point, IgG levels were higher in the previously vaccinated with Sputnik V (Gam-COVID-Vac) / Sputnik Light + Sinopharm (BBIBP-CorV), however, this group had higher IgG levels before the Soberana Plus (FINLAY-FR-1A) administration. In 42 days after vaccination, participants of the age group “45 plus” had the highest IgG level, and in 180 days participants of the age group “45 plus” had the highest IgG level compared to the age group “25-45 years old” (р=0,048).

Conclusion

Conclusion. Soberana Plus (FINLAY-FR-1A) vaccine is quite immunogenic. The highest level of IgG to SARS-CoV-2 marked on day 90 (р

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