Mariani Luciano, Preti Mario, Cristoforoni Paolo, Stigliano Carlo M, Perino Antonio
Regina Elena National Cancer Institute, HPV-Unit, Gynecologic Oncology, Rome, Italy.
Department of Obstetrics and Gynecology, University of Torino, Turin, Italy.
Int J Gynaecol Obstet. 2017 Mar;136(3):258-265. doi: 10.1002/ijgo.12075. Epub 2017 Jan 14.
HPV-related diseases affect anogenital and oropharyngeal regions, heavily affecting the psychosexual dimension of both male and female individuals. HPV vaccination programs based on a bivalent or quadrivalent vaccine have opened broad perspectives for primary prevention. A nonavalent HPV vaccine (9vHPV), covering nine genotypes (HPV6, HPV11, HPV16, HPV18, HPV31, HPV33, HPV45, HPV52, and HPV58), might provide further improvement in terms of direct protection. In the present report, efficacy and safety data from 9vHPV vaccine development programs are examined. Efficacy data come from a pivotal trial, which was conducted among women aged 16-26 years randomly assigned to receive either the 9vHPV or the quadrivalent HPV (4vHPV) vaccine. The 9vHPV vaccine was shown to have potential benefits as compared with 4vHPV, increasing the overall estimated rate of prevention to 90% for cervical cancer and up to 80% for precancerous cervical lesions. For all other HPV-related pre-invasive and invasive lesions, 9vHPV showed potentially greater disease reduction, depending on the anatomic region examined. Thus, the 9vHPV vaccine shows clinical potential for the prevention of HPV-related diseases in both sexes. Future adoption of 9vHPV will depend on factors including market price, cost-effectiveness data, use of a two-dose schedule, and safety and efficacy monitoring in real-life programs.
人乳头瘤病毒（HPV）相关疾病会影响肛门生殖器和口咽区域，严重影响男性和女性个体的性心理层面。基于二价或四价疫苗的HPV疫苗接种计划为一级预防开辟了广阔前景。一种九价HPV疫苗（9vHPV），涵盖九种基因型（HPV6、HPV11、HPV16、HPV18、HPV31、HPV33、HPV45、HPV52和HPV58），可能在直接保护方面提供进一步改善。在本报告中，对9vHPV疫苗研发计划的有效性和安全性数据进行了研究。有效性数据来自一项关键试验，该试验在16至26岁的女性中进行，这些女性被随机分配接受9vHPV或四价HPV（4vHPV）疫苗。与4vHPV相比，9vHPV疫苗显示出潜在益处，将宫颈癌的总体预防估计率提高到90%，将宫颈癌前病变的预防率提高到80%。对于所有其他HPV相关的癌前和浸润性病变，根据所检查的解剖区域，9vHPV显示出可能更大程度的疾病减少。因此，9vHPV疫苗在预防男女HPV相关疾病方面显示出临床潜力。9vHPV疫苗未来的采用将取决于多种因素，包括市场价格、成本效益数据、两剂接种方案的使用以及实际应用中的安全性和有效性监测。
