Introduction: Safety and efficacy of prophylactic HPV vaccines against HPV infection and associated cervical cancers and precursors is well documented in the literature; however, their efficacy against vulval and vaginal endpoints has not been previously assessed.Areas covered: Published results of trials involving licensed HPV vaccines were included. Main efficacy outcomes were histologically confirmed high-grade vulval and vaginal precancer distinguishing those associated with vaccine HPV types and any vulval and vaginal precancerous lesions. Exposure groups included women aged 15-26 or 24-45 years being initially negative for high-risk HPV (hrHPV), negative for the HPV vaccine types, and women unselected by HPV status.Expert opinion: Our results show that the HPV vaccines are equally highly efficacious against vulval/vaginal disease as previously noted for cervical disease. The vaccines demonstrated excellent protection against high-grade vulval and vaginal lesions caused by vaccine-related HPV types among young women who were not initially infected with hrHPV types or types included in the vaccines (vaccine efficacies more than 90%). No protection against high-grade vulval and vaginal lesions associated with HPV16/18 was observed for mid-adult women. Trials were not powered to address protection against invasive cancers.

中文翻译：

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针对人乳头瘤病毒的预防性疫苗接种，以预防外阴癌和阴道癌及其前体。

简介：预防性HPV疫苗针对HPV感染以及相关宫颈癌和前体的安全性和有效性已在文献中得到了充分证明。但是，以前尚未评估它们对外阴和阴道端点的功效。涵盖范围：包括已发表的涉及许可的HPV疫苗的试验结果。组织学上证实的主要疗效结果是高级别的外阴癌和阴道癌前病变，可将其与疫苗HPV类型以及任何外阴癌和阴道癌前病变相关联。暴露人群包括15-26岁或24-45岁的女性，最初对高危HPV（hrHPV）阴性，对HPV疫苗类型阴性，以及未按HPV身份选择的女性。我们的结果表明，HPV疫苗与以前提到的宫颈疾病一样，对外阴/阴道疾病同样有效。在最初未感染hrHPV类型或疫苗中包含的类型的年轻女性中，疫苗显示出出色的保护作用，可有效防止由疫苗相关的HPV类型引起的严重外阴和阴道病变（疫苗效率超过90％）。对于中成年女性，未观察到针对与HPV16 / 18相关的严重外阴和阴道病变的保护措施。没有能力进行针对侵袭性癌症的保护的试验。在最初未感染hrHPV类型或疫苗中包含的类型的年轻女性中，疫苗显示出出色的保护作用，可有效防止由疫苗相关的HPV类型引起的严重外阴和阴道病变（疫苗效率超过90％）。对于中成年女性，未观察到针对与HPV16 / 18相关的严重外阴和阴道病变的保护措施。没有能力进行针对侵袭性癌症的保护的试验。在最初未感染hrHPV类型或疫苗中包含的类型的年轻女性中，疫苗显示出出色的保护作用，可有效防止由疫苗相关的HPV类型引起的严重外阴和阴道病变（疫苗效率超过90％）。对于中成年女性，未观察到针对与HPV16 / 18相关的严重外阴和阴道病变的保护措施。没有能力进行针对侵袭性癌症的保护的试验。