VCS Inc, 265 Faraday St, Carlton, VIC 3053, Australia.
BMC Med. 2013 Oct 22;11:227. doi: 10.1186/1741-7015-11-227.
Australia was one of the first countries to introduce a publicly funded national human papillomavirus (HPV) vaccination program that commenced in April 2007, using the quadrivalent HPV vaccine targeting 12- to 13-year-old girls on an ongoing basis. Two-year catch-up programs were offered to 14- to 17- year-old girls in schools and 18- to 26-year-old women in community-based settings. We present data from the school-based program on population-level vaccine effectiveness against cervical abnormalities in Victoria, Australia.
Data for women age-eligible for the HPV vaccination program were linked between the Victorian Cervical Cytology Registry and the National HPV Vaccination Program Register to create a cohort of screening women who were either vaccinated or unvaccinated. Entry into the cohort was 1 April 2007 or at first Pap test for women not already screening. Vaccine effectiveness (VE) and hazard ratios (HR) for cervical abnormalities by vaccination status between 1 April 2007 and 31 December 2011 were calculated using proportional hazards regression.
The study included 14,085 unvaccinated and 24,871 vaccinated women attending screening who were eligible for vaccination at school, 85.0% of whom had received three doses. Detection rates of histologically confirmed high-grade (HG) cervical abnormalities and high-grade cytology (HGC) were significantly lower for vaccinated women (any dose) (HG 4.8 per 1,000 person-years, HGC 11.9 per 1,000 person-years) compared with unvaccinated women (HG 6.4 per 1,000 person-years, HGC 15.3 per 1,000 person-years) HR 0.72 (95% CI 0.58 to 0.91) and HR 0.75 (95% CI 0.65 to 0.87), respectively. The HR for low-grade (LG) cytological abnormalities was 0.76 (95% CI 0.72 to 0.80). VE adjusted a priori for age at first screening, socioeconomic status and remoteness index, for women who were completely vaccinated, was greatest for CIN3+/AIS at 47.5% (95% CI 22.7 to 64.4) and 36.4% (95% CI 9.8 to 55.1) for women who received any dose of vaccine, and was negatively associated with age. For women who received only one or two doses of vaccine, HRs for HG histology were not significantly different from 1.0, although the number of outcomes was small.
A population-based HPV vaccination program in schools significantly reduced cervical abnormalities for vaccinated women within five years of implementation, with the greatest vaccine effectiveness observed for the youngest women.
澳大利亚是最早引入公共资助的全国人乳头瘤病毒(HPV)疫苗接种计划的国家之一,该计划于 2007 年 4 月开始实施,为 12 至 13 岁的女孩持续提供四价 HPV 疫苗。为 14 至 17 岁的在校女孩和 18 至 26 岁的社区妇女提供了为期两年的补种计划。我们报告了澳大利亚维多利亚州学校为基础的 HPV 疫苗接种计划在人群水平上对宫颈癌前病变的疫苗有效性数据。
将符合 HPV 疫苗接种计划年龄要求的女性数据在维多利亚州宫颈细胞学登记处和国家 HPV 疫苗接种计划登记处之间进行链接,创建了一个筛查女性队列,其中包括接种疫苗或未接种疫苗的女性。队列的纳入时间为 2007 年 4 月 1 日或首次巴氏涂片检查时未进行筛查的女性。2007 年 4 月 1 日至 2011 年 12 月 31 日,通过比例风险回归计算接种状态与宫颈癌前病变之间的疫苗有效性(VE)和危险比(HR)。
该研究纳入了 14085 名未接种疫苗和 24871 名接种疫苗的在校筛查女性,其中 85.0%的女性已接种三剂疫苗。与未接种疫苗的女性相比(任何剂量),接种疫苗的女性(任何剂量)的组织学证实的高级别(HG)宫颈病变和高级别细胞学(HGC)的检出率显著降低(HG 每 1000 人年 4.8 例,HGC 每 1000 人年 11.9 例)(HG 每 1000 人年 6.4 例,HGC 每 1000 人年 15.3 例)HR 0.72(95%CI 0.58 至 0.91)和 HR 0.75(95%CI 0.65 至 0.87),LG 细胞学异常的 HR 为 0.76(95%CI 0.72 至 0.80)。对于完全接种疫苗的女性,接种 HPV 疫苗的 CIN3+/AIS 的 VE 预先调整了首次筛查年龄、社会经济状况和偏远指数,最大为 47.5%(95%CI 22.7 至 64.4)和 36.4%(95%CI 9.8 至 55.1),而对于接种任何剂量疫苗的女性则为负相关。对于仅接种一剂或两剂疫苗的女性,HG 组织学的 HR 与 1.0 无显著差异,尽管结局数量较少。
基于人群的学校 HPV 疫苗接种计划在实施五年内显著降低了接种女性的宫颈癌前病变,对于最年轻的女性,疫苗的有效性最大。