Abstract: In this paper, we review the published evidence about the long-term efficacy of the available human papillomavirus (HPV) vaccines and their safety profile. Two prophylactic HPV vaccines – bivalent (bHPV) and quadrivalent (qHPV) – are now available, and vaccination programs are being widely implemented, primarily targeting adolescent girls. Efficacy has been widely demonstrated for both vaccines. Since the risk of HPV exposure potentially persists throughout a woman’s sexual life, vaccine duration of protection is critical to overall effectiveness. Interpreting the results of long-term efficacy studies for the two HPV vaccines can be puzzling, due to the heterogeneity of studies, different methods used in the assessment of immunogenicity, histopathological and virological end points, and statistical power issues. Moreover, an immunologic correlate of protection has not yet been established, and it is unknown whether higher antibody levels will really result in a longer duration of protection. Disease prevention remains the most important measure of long-term duration of vaccine efficacy. To date, the longest follow-up of an HPV vaccine has been 9.4 years for the bHPV vaccine. Long-term follow-up for qHPV vaccine goes up to 8 years. The vaccine continues to be immunogenic and well tolerated up to 9 years following vaccination. All randomized controlled clinical trials of the bHPV and the qHPV vaccines provide evidence of an excellent safety profile. The most common complaint reported is pain in the injection site, which is self-limiting and spontaneously resolved. The incidence of systemic adverse events (AEs), serious AEs, and discontinuations due to a serious AE reported in clinical studies are similar between the two vaccines and their control groups. In particular, no increased risk of autoimmune disease has been shown among HPV-vaccinated subjects in long-term observation studies. As these are crucial topics in HPV vaccination, it is important to establish systems for continued monitoring of vaccine immunogenicity, efficacy, and safety over time. Keywords: HPV vaccines, effectiveness, adverse events

Rosa De Vincenzo

Carmine Conte

Caterina Ricci

Giovanni Scambia

Giovanni Capelli

International Journal of Women s Health

International Journal of Women's Health is an international, peer-reviewed, open access, online journal.    Publishing original research, reports, editorials, reviews and commentaries on all aspects of women's healthcare including gynecology, obstetrics, and breast cancer.    Subject areas include:    Chronic conditions including cancers of various organs specific and not specific to women  Migraine, headaches, arthritis, osteoporosis  Endocrine and autoimmune syndromes - asthma, multiple sclerosis, lupus, diabetes  Sexual and reproductive health including fertility patterns and emerging technologies to address infertility  Infectious disease with chronic sequelae including HIV/AIDS, HPV, PID, and other STDs  Psychological and psychosocial conditions - depression across the life span, substance abuse, domestic violence  Health maintenance among aging females - factors affecting the quality of life including physical, social and mental issues  Avenues for health promotion and disease prevention across the life span  Male vs female incidence comparisons for conditions that affect both genders.

The International Journal of Women's Health is an international, peer-reviewed, open access online journal. It publishes original research, reports, editorials, reviews, and commentaries on all aspects of women's healthcare, including gynecology, obstetrics, and breast cancer. The subject areas include chronic conditions, such as cancers specific and non-specific to women; migraines, headaches, arthritis, and osteoporosis; endocrine and autoimmune syndromes like asthma, multiple sclerosis, lupus, and diabetes; sexual and reproductive health, including fertility patterns and emerging technologies to address infertility; infectious diseases with chronic sequelae, including HIV/AIDS, HPV, PID, and other STDs; psychological and psychosocial conditions, such as depression across the lifespan, substance abuse, and domestic violence; health maintenance among aging females, focusing on factors affecting quality of life, including physical, social, and mental issues; avenues for health promotion and disease prevention across the lifespan; and male vs female incidence comparisons for conditions that affect both genders.

《International Journal of Women's Health》是一本国际性的、经过同行评审的开放获取在线期刊。该期刊发表关于女性健康各个方面的原创研究、报告、社论、综述和评论，包括妇科、产科和乳腺癌等领域。涉及的主题包括：慢性疾病，包括特定和非特定于女性的各种器官癌症；偏头痛、头痛、关节炎、骨质疏松；内分泌和自身免疫综合症，如哮喘、多发性硬化、狼疮、糖尿病；性与生殖健康，包括生育模式和应对不孕不育的新兴技术；具有慢性后遗症的传染病，包括HIV/AIDS、HPV、盆腔炎和其他性传播疾病；心理和社会心理状况，包括整个生命阶段的抑郁、药物滥用、家庭暴力；老年女性的健康维护，包括影响生活质量的身体、社会和心理因素；促进健康和预防疾病的途径，贯穿整个生命阶段；对影响两性健康的疾病进行男性与女性的发病率比较。

International Journal of Women's Health

Long-term efficacy and safety of human papillomavirus vaccination

All randomized controlled clinical trials of the bHPV and the qHPV vaccines provide evidence of an excellent safety profile, and no increased risk of autoimmune disease has been shown among HPV-vaccinated subjects in long-term observation studies.

Category	Quartile
医学	4
医学, 妇产科学	4

Long-term efficacy and safety of human papillomavirus vaccination

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Category	Quartile
OBSTETRICS & GYNECOLOGY	2