Unit of Virus, Lifestyle and Genes, Danish Cancer Society Research Center, Denmark.
Department of Gynecology, Rigshospitalet, University of Copenhagen, Denmark.
Clin Infect Dis. 2018 Jan 18;66(3):339-345. doi: 10.1093/cid/cix797.
The long-term effectiveness of the quadrivalent human papillomavirus (qHPV) vaccine was assessed by monitoring the combined incidence of cervical intraepithelial neoplasia (CIN2, CIN3), adenocarcinoma in situ (AIS), and cervical cancer related to HPV16 or HPV18.
Women from Nordic countries of Denmark, Iceland, Norway, and Sweden who received a 3-dose regimen of the qHPV vaccine in the beginning of FUTURE II (Females United to Unilaterally Reduce Endo/Ectocervical Disease; V501-015, base study NCT00092534) are followed through different national registries. Effectiveness analyses were conducted approximately 2 years following completion of the base study and occur approximately every 2 years thereafter for 10 years (ie, 14 years from day 1 of the base study). Vaccine effectiveness against HPV16/18-related CIN2 or worse (CIN2+) was estimated by comparing the observed incidence with the expected incidence of CIN2+ in an unvaccinated cohort using historical registry data.
In the per-protocol population (2084 women) analysis of effectiveness after the first 12 years, there were no breakthrough cases of HPV16/18 CIN2+ after 9437 person- years of follow-up. Statistical power was sufficient to conclude that qHPV vaccine effectiveness remains above 90% for at least 10 years. The number of person-years during the follow-up interval of 10-12 years is continuing to accrue and shows a trend toward continuing effectiveness of the vaccine during that period.
The qHPV vaccine shows continued protection in women through at least 10 years, with a trend for continued protection through 12 years of follow-up.
NCT00092534.
V501-015.
通过监测 HPV16 或 HPV18 相关的宫颈上皮内瘤变（CIN2、CIN3）、原位腺癌（AIS）和宫颈癌的综合发病率，评估了四价人乳头瘤病毒（qHPV）疫苗的长期效果。
在 FUTURE II 研究开始时（女性联合单侧减少宫颈内和外病变；V501-015，基础研究 NCT00092534），丹麦、冰岛、挪威和瑞典的北欧国家的女性接受了 3 剂 qHPV 疫苗接种。通过不同的国家登记处对这些女性进行随访。在基础研究完成后大约 2 年进行有效性分析，此后每 2 年进行一次，持续 10 年（即从基础研究第一天开始的 14 年）。通过比较使用历史登记数据的未接种疫苗队列中 CIN2+的预期发生率和观察到的 CIN2+发生率，估计疫苗对 HPV16/18 相关 CIN2 或更高级别病变（CIN2+）的有效性。
在第 12 年的方案人群（2084 名女性）有效性分析中，在 9437 人年的随访中没有 HPV16/18 CIN2+的突破性病例。统计效力足以得出结论，qHPV 疫苗的有效性至少在 10 年内仍保持在 90%以上。在 10-12 年的随访间隔期间，累积的人年数继续增加，并显示出在该期间疫苗持续有效的趋势。
qHPV 疫苗在女性中至少 10 年持续提供保护，在 12 年的随访中继续保护的趋势。
NCT00092534。
V501-015。
