epidemiologyЭпидемиология и ВакцинопрофилактикаEpidemiology and Vaccinal Prevention2073-30462619-0494«Numicom» LLC10.31631/2073-3046-2025-24-3-25-34epidemiology-2252Research ArticleОРИГИНАЛЬНЫЕ СТАТЬИORIGINAL ARTICLESИммунологическая эффективность и безопасность вакцины для профилактики менингококковой инфекции серогрупп A, C, Y, W, X при иммунизации взрослых (результаты клинических исследований)Results of clinical trial in Russia to assess immunological efficacy and safety of meningococcal vaccine (serogroups A, C, Y, W, X) in adultshttps://orcid.org/0000-0003-4398-5703ФельдблюмИ. В.Fel'dblyumI. V.

Фельдблюм Ирина Викторовна – д. м. н., профессор, заведующая кафедрой эпидемиологии

614990 г. Пермь, ул. Петропавловская, 26

+7 (342) 218-16-68

Irina V. Feldblum– Dr. Sci. (Med.), professor, head of the Department of Epidemiology

614990, Perm city, Petropavlavskaya street, 26

8-912-885-32-36

irinablum@mail.ruhttps://orcid.org/0000-0001-9792-7491ГолодноваС. О.GolodnovaS. O.

Голоднова Светлана Олеговна – к. м. н., доцент кафедры эпидемиологии

614990 г. Пермь, ул. Петропавловская, 26

+7 (342) 218-16-68

Svetlana O.Golodnova – Cand. Sci. (Med.), Associate Professor of the Department of Epidemiology

614990 Perm, Petropavlovsk str., 26

+7 (342) 218-16-68

svetik@xakep.ruhttps://orcid.org/0000-0002-4467-4707АлыеваМ. Х.AlyevaM. Kh.

Алыева Мая Ходжимурадовна – к. м. н., доцент кафедры эпидемиологии

614990 г. Пермь, ул. Петропавловская, 26

+7 (342) 218-16-68

Maya Kh.Alyeva – Cand. Sci. (Med.), Associate Professor of the Department of Epidemiology

Petropavlovsk str., 26, Perm, 614990

+7 (342) 218-16-68

alyeva.mx@mail.ruhttps://orcid.org/0000-0002-3826-7734РепинТ. М.RepinT. M.

Репин Тимофей Максимович – к. м. н., ассистент кафедры эпидемиологии

614990, г. Пермь, ул. Петропавловская, 26

+7 (342) 218-16-68

Timofey M. Repin – Cand. Sci. (Med.), Assistant of the Department of Epidemiology

26 Petropavlovskaya Street, Perm, 614990

+7 (342) 218-16-68

timashrepin@yandex.ruhttps://orcid.org/0000-0002-7827-4488ГореликоваЕ. В.GorelikovaE. V.

Гореликова Екатерина Владимировна – к. м. н., доцент кафедры эпидемиологии

614990, г. Пермь, ул. Петропавловская, 26

+7 (342) 218-16-68

Ekaterina V. Gorelikova – Cand. Sci. (Med.), associate professor of the epidemiology department, Perm State Medical University named after Academician E.A. Wagner

614990, Perm, Petropavlovskaya St., 26

+7 (342) 218-16-68

epidgor@mail.ruhttps://orcid.org/0000-0002-3241-1053КоровкинА. С.KorovkinA. S.

Коровкин Алексей Сергеевич – к. м. н., старший научный сотрудник

Москва

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

Moscow.

+7 916 255 63 61

alexkorovkin@mail.ruhttps://orcid.org/0000-0001-8417-1963СафоноваЕ. С.SafonovaE. S.

Сафонова Екатерина Сергеевна – к. м. н., медицинский директор

Москва

+7 (342) 218-16-68

Ekaterina S. Safonova – Cand. Sci. (Med.)

Moscow.

+7 (342) 218-16-68

Safonova@pharmaid.comhttps://orcid.org/0000-0002-0742-1575ВласовА. М.VlasovA. M.

Власов Александр Михайлович – к. фарм. н., доцент кафедры фармацевтической и токсикологической химии им. А.П. Арзамасцева

119048, Москва, ул. Трубецкая, д. 8, стр. 2

8 (499)248-53-83

Alexander M. Vlasov – Cand. Sci. (Pharm.), Associate Professor of the Department of Pharmaceutical and Toxicological Chemistry named after A.P. Arzamastsev

119048, Moscow, Trubetskaya str., 8, p. 2.

8 (499) 248-53-83

vlasov@pharmaid.comФГБОУ ВО «Пермский государственный медицинский университет имени академика Е. А. Вагнера» Минздрава РоссииРоссияIrina V. Feldblum– Dr. Sci. (Med.), professor, head of the Department of EpidemiologyRussian FederationФГБОУ ВО «Пермский государственный медицинский университет имени академика Е. А. Вагнера» Минздрава РоссииРоссияFederal State Budgetary Educational Institution of Higher Education Academician E.A. Vagner Perm State Medical University of the Ministry of Health of the Russian FederationRussian FederationФГБНУ «НИИ вакцин и сывороток им. И. И. Мечникова»РоссияFederal State Budgetary Scientific Institution «I. I. Mechnikov Scientific Research Institute of Vaccines and Serums»Russian FederationООО «ФАРМ ЭЙД ЛТД»РоссияLimited Liability Company «PHARM AID LTD»Russian FederationООО «ФАРМ ЭЙД ЛТД»; ФГБОУ ВО Первый Московский государственный медицинский университет имени И. М. Сеченова Минздрава России (Сеченовский Университет)РоссияLimited Liability Company «PHARM AID LTD»; Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University)Russian Federation2025280720252432534Copyright © Фельдблюм И.В., Голоднова С.О., Алыева М.Х., Репин Т.М., Гореликова Е.В., Коровкин А.С., Сафонова Е.С., Власов А.М., 20252025Фельдблюм И.В., Голоднова С.О., Алыева М.Х., Репин Т.М., Гореликова Е.В., Коровкин А.С., Сафонова Е.С., Власов А.М.Fel'dblyum I.V., Golodnova S.O., Alyeva M.K., Repin T.M., Gorelikova E.V., Korovkin A.S., Safonova E.S., Vlasov A.M.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.epidemvac.ru/jour/article/view/2252

Актуальность. Различный серогрупповой состав возбудителей менингококковой инфекции, циркулирующих в разных странах, миграционные процессы и активный аэрозольный механизм передачи требуют использования в целях профилактики вакцин с максимально широким серогрупповым покрытием.Цель. Оценка иммунологической эффективности и безопасности вакцины МЕНВЭЙД® для профилактики менингококковых инфекций серогрупп A, C, Y, W, X в Российской Федерации.Материалы и методы. Иммунологическая эффективность и безопасность dакцины Менвейд были изучены в проспективном сравнительном рандомизированном двойном слепом исследовании в параллельных группах взрослых добровольцев в возрасте от 18 до 65 лет. В рамках клинического исследования 60 взрослых добровольцев были рандомизированы в две группы по схеме 1:1 (группа I, n = 30; группа II, n = 30). Вакциной сравнения явилась Менактра®.Результаты исследования. Для всех 5 серогрупп вакцины МЕНВЭЙД® в отношении препарата сравнения, как первичные, так и вторичные критерии оценки иммуногенности при вакцинации взрослых в возрасте 18–60 лет достигнуты, что доказывает не меньшую эффективность вакцины МЕНВЭЙД®, по сравнению с препаратом сравнения Менактра®. Также в исследовании вакцина МЕНВЭЙД® продемонстрировала достоверно более высокий уровень среднего геометрического титров антител для серогрупп C, Y, W по сравнению с вакциной сравнения. В ходе проведения клинического исследования с участием взрослых всего было зарегистрировано 132 нежелательных явления (НЯ), из них 124 НЯ имели связь с введением вакцин и были представлены местными и системными реакциями: 66 НЯ были зарегистрированы у участников исследования из группы I (220 %) и 58 НЯ у участников исследования из группы II (193,3 %). Достоверной разницы в количестве НЯ между группами не выявлено. Серьезных НЯ в данном исследовании зарегистрировано не было.Заключение. Вакцина МЕНВЭЙД® для профилактики менингококковой инфекции серогрупп A, C, Y, W, X характеризовалась неменьшей эффективностью, сопоставимой безопасностью по сравнению с вакциной сравнения при иммунизации здоровых субъектов в возрасте от 18 до 60 лет.

Relevance. The diverse serogroup composition of meningococcal pathogens circulating in different countries, the challenges in predicting serogroup prevalence, migration processes, and the active aerosol transmission mechanism of meningococcal infection necessitate the use of vaccines with the broadest possible serogroup coverage for effective prevention.Aim. To evaluate the immunological efficacy and safety of the MENVAID® vaccine for the prevention of meningococcal infections caused by serogroups A, C, Y, W, and X in the Russian Federation.Materials and Methods. The immunological efficacy and safety of the MENVAID® vaccine were assessed in a prospective, comparative, randomized, double-blind clinical trial with parallel groups involving adult volunteers aged 18 to 65 years. A total of 60 adult volunteers were randomized into two groups in a 1:1 ratio (Group I, n = 30; Group II, n = 30). The comparator vaccine was Menactra®.Study Results. For all five serogroups included in the MENVAID® vaccine, both the primary and secondary immunogenicity endpoints in adults aged 18–60 years were met in comparison to the reference product (Difference ≤10 %, GMT ratios ≥0.5, respectively), confirming that the immunogenicity of MENVAID® is non-inferior to that of the comparator vaccine, Menactra®. Moreover, MENVAID® demonstrated significantly higher GMT levels for serogroups C, Y, and W compared to the comparator vaccine. In total, 132 adverse events (AEs) were reported during the study in adults, of which 124 were related to vaccine administration and were represented by local and systemic reactions: 66 AEs were recorded in Group I participants (220 %), and 58 AEs in Group II participants (193.3 %). No statistically significant difference in the number of AEs between the groups was observed. No serious adverse events (SAEs) were reported during the study.Conclusion. The MENVAID® vaccine for the prevention of meningococcal infection caused by serogroups A, C, Y, W, and X demonstrated non-inferior efficacy and comparable safety to the comparator vaccine when administered to healthy individuals aged 18 to 60 years.

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