safetyriskБезопасность и риск фармакотерапииSafety and Risk of Pharmacotherapy2312-78212619-1164Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)10.30895/2312-7821-2020-8-3-141-150safetyrisk-180Research ArticleОБЗОРЫREVIEWSТекущие проблемы и будущие направления вакцинации против вируса папилломы человека (ВПЧ)Ongoing challenges and future directions of human papillomavirus vaccinationhttps://orcid.org/0000-0003-0770-8020АляутдинаО. С.AlyautdinaO. S.

д-р мед. наук, профессор

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

Dr. Sci. (Med.), Professor

8/2 Trubetskaya St., Moscow 119991

olasa@list.ruПрилуцкаяВ. Ю.PrilutskayaV. Yu.

Scopus Author ID: 57203243192

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

Scopus Author ID: 57203243192

8/2 Trubetskaya St., Moscow 119991

anturiumvika@mail.ruФедеральное государственное автономное образовательное учреждение высшего образования «Первый Московский государственный медицинский университет имени И. М. Сеченова» Министерства здравоохранения Российской ФедерацииРоссияI. M. Sechenov First Moscow State Medical UniversityRussian Federation20200209202083141150Copyright © Аляутдина О.С., Прилуцкая В.Ю., 20202020Аляутдина О.С., Прилуцкая В.Ю.Alyautdina O.S., Prilutskaya V.Y.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.risksafety.ru/jour/article/view/180

Рак шейки матки, вызываемый вирусом папилломы человека (ВПЧ) 16 и 18 типов, является одним из самых распространенных злокачественных новообразований у женщин. Другие высокоонкогенные типы вируса способствуют возникновению рака влагалища, вульвы, пениса, анального канала, злокачественных новообразований головы и шеи. Низкоонкогенные типы ВПЧ, такие как 6 и 11, могут быть причиной аногенитальных бородавок и папилломатоза верхних дыхательных путей. Эти заболевания возможно предотвратить с помощью вакцинации до инфицирования вирусом. Цель работы: систематизация актуальных данных по профилактике ВПЧ-ассоциированных заболеваний с помощью вакцинации. В настоящее время в мире зарегистрированы три вакцины против вируса папилломы человека — Церварикс®, Гардасил® и Гардасил®9. Обширные клинические и пострегистрационные исследования свидетельствуют о безопасности и высокой эффективности данных вакцин (до 100%) в отношении возникновения интраэпителиальных неоплазий шейки матки, вульвы и влагалища при введении их пациенткам, не инфицированным данными типами вируса ранее. Однако существует ряд нерешенных вопросов, стимулирующих проведение дальнейших клинических исследований по поиску универсальной вакцины. Прежде всего эффективность указанных вакцин ограничена включенными типами ВПЧ. Только в 2011 г. был поднят вопрос о необходимости вакцинации лиц мужского пола. Также периодически происходит пересмотр рекомендаций по кратности вакцинации вследствие появления новых результатов исследований иммуногенности вакцины. Снижение кратности иммунизации особенно актуально для развивающихся стран с ограниченными финансовыми ресурсами и высокой заболеваемостью раком шейки матки. Таким образом, для достижения элиминации ВПЧ во всем мире необходимо проведение глобальных программ вакцинации, в том числе оптимальных по доступности и кратности вакцинации для развивающихся стран, увеличение охвата вакцинацией по возрасту и полу, а также расширение программ скрининга в области онкологии.

Cervical cancer caused by human papillomavirus (HPV) types 16 and 18 is one of the most common cancer types in women. Other high-risk HPV types may cause vaginal cancer, vulval cancer, penile cancer, anal cancer, head and neck cancer. Low-risk HPV types, such as 6 and 11, can cause anogenital warts and recurrent respiratory papillomatosis. These diseases may be prevented by vaccinating women and men before contracting the virus. The aim of the study was to summarise current data on using vaccines for the prevention of HPV-associated diseases. Currently, there are three HPV vaccines available on the market: Cervarix®, Gardasil®, and Gardasil®9. Extensive clinical and post-licensing studies show that these vaccines are safe and highly effective (up to 100 %) in preventing vaginal, vulval, and cervical intraepithelial neoplasias when administered to patients who were not previously infected with these HPV types. However, there are a number of unresolved issues that encourage further clinical research to find a universal vaccine. First of all, the effectiveness of these vaccines is limited to the HPV types covered by a particular vaccine. It was only in 2011 that the question was raised about the need to vaccinate males. Also, the recommendations on the frequency of vaccination are periodically revised in line with new immunogenicity study results. Reducing the frequency of immunisation is particularly relevant for developing countries with limited financial resources and a high incidence of cervical cancer. Thus, global vaccination programmes, including those with optimal availability and immunisation frequency for developing countries, higher vaccination coverage in terms of age and sex, and expansion of cancer screening programmes are necessary to eliminate HPV worldwide.

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