HPV疫苗的临床应用价值

Clinical Application of HPV Vaccine

通过对人乳头状瘤病毒(HPV)结构的阐述,介绍HPV预防性疫苗的机制及临床应用现状。目前已被美国食品和药物管理局(FDA)认证上市的预防性疫苗有3种,即四价疫苗(Gardasil)、二价疫苗(Cervarix)和九价疫苗(Gardasil9)。四价疫苗(Gardasil)是针对HPV6/11/16/18型的疫苗;二价疫苗(Cervarix)是针对HPV16/18型的疫苗;九价疫苗(Gardasil9)是针对HPV6/11/16/18/31/33/45/52/58型疫苗。综合预防性疫苗的临床试验及全球上市后的研究资料显示,3种疫苗的保护效力至今已分别在其观察期内持续存在,且无严重不良反应。但对疫苗接种后的远期效果评估尚需继续,对于可能发生的不良事件等还需长期监测。我国自主研发的二价疫苗,也在进行Ⅲ期临床试验,宫颈癌疫苗有望在我国女性中接种。

We introduced the structure of human papilloma virus （HPV）, the mechanism of prophylactic, HPV vaccines and their clinical application. Three kinds of prophylactic HPV vaccines have been approved by FDA in the United States, including the quadrivalent HPV vaccine （Gardasil）, the bivalent HPV vaccine （Cervarix） and the nine-valent HPV vaccine （Gardasil9）. The Gardasil was designed to work on the HPV 6/11/ 16/18, the Cervarix on the HPV 16/18, and the Gardasil9 on the HPV 6/11/16/18/31/33/45/52/58. The data of clinical trials of prophylactic HPV vaccines and the clinical data post-marketing were reviewed. Three kinds of HPV vaccines were showed their persistent protective efficacy during the follow-up visit, up to now, without serious adverse reaction. Of course, it is necessary to evaluate unceasingly the efficacy, and to monitor long-term the potential adverse reaction. The bivalent HPV vaccine developed independently by our country has been doing the Phase Ⅲ clinical trial. It is hopeful in near future that the cervical cancer vaccine be applied in Chinese women.