Mariani Luciano, Vici Patrizia, Suligoi Barbara, Checcucci-Lisi Giovanni, Drury Rosybel
HPV-UNIT, Department of Gynecologic Oncology, Regina Elena National Cancer Institute, Rome, Italy,
Adv Ther. 2015 Jan;32(1):10-30. doi: 10.1007/s12325-015-0178-4. Epub 2015 Jan 27.
Since 2007, many countries have implemented national human papillomavirus (HPV) vaccination programs with the quadrivalent HPV (4HPV) vaccine that has been shown to be efficacious in clinical trials involving 25,000 subjects. Two vaccine serotypes, HPV16 and 18, are responsible for cervical cancer and other HPV-related cancers, but the impact of the 4HPV vaccine on these cancers cannot be seen immediately as there is a considerable lag between infection with HPV and cancer development. The other two serotypes, HPV6 and 11, are responsible for genital warts (GWs), which develop within a few months after infection, making GWs an early clinical endpoint for the assessment of the impact of 4HPV vaccination.
We performed a systematic literature search in PubMed to identify all published studies on 4HPV vaccination, including those that assessed the impact of 4HPV vaccination programs on the incidence of GWs at a population level around the world.
A total of 354 records were identified in the PubMed search. After screening and obtaining full papers for 56 publications, 16 publications presenting data on the impact or effectiveness of 4HPV vaccination on GWs were identified. These reported data on the impact or effectiveness of 4HPV in six countries [Australia (n = 6), New Zealand (n = 2), United States (n = 3), Denmark (n = 2), Germany (n = 1), and Sweden (n = 2)]. In Australia, no GWs were diagnosed in women aged <21 years who reported being vaccinated. A 92.6% reduction in GWs incidence was reported for all women in this age group, where the vaccine uptake rate (VUR) was 70% for 3 doses. The highest reductions were reported in countries with high VURs, mostly through school-based vaccination programs, although high VURs were obtained with some non-school-based programs.
The results are coherent with the GWs incidence reduction reported in clinical trials and are an early indicator of what can be expected for the long-term clinical impact on vaccine-type HPV-related cancers.
自2007年以来，许多国家已实施国家人乳头瘤病毒（HPV）疫苗接种计划，采用四价HPV（4HPV）疫苗，该疫苗在涉及25000名受试者的临床试验中已显示出有效性。两种疫苗血清型，即HPV16和HPV18，是宫颈癌及其他HPV相关癌症的致病因素，但4HPV疫苗对这些癌症的影响无法立即显现，因为HPV感染与癌症发展之间存在相当长的时间间隔。另外两种血清型，即HPV6和HPV11，是尖锐湿疣（GWs）的致病因素，尖锐湿疣在感染后几个月内就会发生，这使得尖锐湿疣成为评估4HPV疫苗接种影响的一个早期临床终点。
我们在PubMed上进行了系统的文献检索，以识别所有已发表的关于4HPV疫苗接种的研究，包括那些在全球范围内评估4HPV疫苗接种计划对人群层面尖锐湿疣发病率影响的研究。
在PubMed检索中总共识别出354条记录。在筛选并获取56篇出版物的全文后，确定了16篇呈现4HPV疫苗接种对尖锐湿疣影响或有效性数据的出版物。这些出版物报告了4HPV在六个国家[澳大利亚（n = 6）、新西兰（n = 2）、美国（n = 3）、丹麦（n = 2）、德国（n = 1）和瑞典（n = 2）]的影响或有效性数据。在澳大利亚，报告接种疫苗的21岁以下女性中未诊断出尖锐湿疣。该年龄组所有女性的尖锐湿疣发病率降低了92.6%，其中三剂疫苗的接种率（VUR）为70%。在接种率高的国家报告的降低率最高，大多是通过基于学校的疫苗接种计划，不过一些非基于学校的计划也获得了高接种率。
这些结果与临床试验中报告的尖锐湿疣发病率降低情况一致，并且是对疫苗型HPV相关癌症长期临床影响预期的一个早期指标。
