Unit of Infections and Cancer, Cancer Epidemiology Research Program, IDIBELL, Institut Català d'Oncologia-ICO, CIBER-ESP, L'Hospitalet de Llobregat, Catalonia 08907, Spain.
Br J Cancer. 2011 Jun 28;105(1):28-37. doi: 10.1038/bjc.2011.185. Epub 2011 May 31.
Previous analyses from a randomised trial in women aged 24-45 years have shown the quadrivalent human papillomavirus (qHPV) vaccine to be efficacious in the prevention of infection, cervical intraepithelial neoplasia (CIN), and external genital lesions (EGLs) related to HPV 6/11/16/18. In this report, we present end-of-study efficacy, safety, and immunogenicity data with a median follow-up time of 4.0 years.
We enrolled 3819 24-45-year-old women with no history of cervical disease or genital warts in the past 5 years. Women received quadrivalent vaccine or placebo at day 1, and at months 2 and 6. Ascertainment of CIN/EGL was accomplished through Pap testing, genital inspection, and cervicovaginal sampling (every 6 months). The main analysis was conducted in a per-protocol efficacy population (that received three doses, was naive to the relevant HPV types at day 1, and remained free of infection through month 7). Efficacy was also estimated in other naive and non-naive populations.
Vaccine efficacy against the combined incidence of persistent infection, CIN/EGL related to HPV6/11/16/18 in the per-protocol population was 88.7% (95% CI: 78.1, 94.8). Efficacy for women who were seropositive and DNA negative for the relevant vaccine HPV type at the time of enrolment who received at least 1 dose was 66.9% (95% CI: 4.3, 90.6). At month 48, 91.5, 92.0, 97.4, and 47.9% of vaccinated women were seropositive to HPV 6/11/16/18, respectively. No serious vaccine-related adverse experiences were reported.
The qHPV vaccine demonstrated high efficacy, immunogenicity, and acceptable safety in women aged 24-45 years, regardless of previous exposure to HPV vaccine type.
先前在 24-45 岁女性中进行的一项随机试验的分析表明，四价人乳头瘤病毒（qHPV）疫苗可有效预防 HPV6/11/16/18 型感染、宫颈上皮内瘤变（CIN）和与 HPV6/11/16/18 相关的外阴病变（EGL）。在此报告中，我们介绍了中位随访时间为 4.0 年的研究结束时的疗效、安全性和免疫原性数据。
我们招募了 3819 名 24-45 岁、过去 5 年内无宫颈疾病或生殖器疣病史的女性。女性在第 1 天、第 2 天和第 6 天接受四价疫苗或安慰剂。通过巴氏试验、生殖器检查和宫颈阴道取样（每 6 个月一次）来确定 CIN/EGL。主要分析在方案符合人群中进行（该人群接受了 3 剂疫苗、在第 1 天对相关 HPV 类型呈初次感染、且在第 7 个月前保持无感染）。在其他初次感染和非初次感染人群中也进行了疗效估计。
在方案符合人群中，疫苗对 HPV6/11/16/18 相关持续性感染、CIN/EGL 的联合发生率的疗效为 88.7%（95%CI：78.1，94.8）。对于在入组时已对相关疫苗 HPV 型呈血清阳性和 DNA 阴性、且至少接受了 1 剂疫苗的女性，疗效为 66.9%（95%CI：4.3，90.6）。在第 48、48、48、48 和 48 个月时，分别有 91.5%、92.0%、97.4%和 47.9%的接种女性对 HPV6/11/16/18 呈血清阳性。未报告与疫苗相关的严重不良事件。
qHPV 疫苗在 24-45 岁女性中具有高疗效、免疫原性和可接受的安全性，无论其先前是否接触过 HPV 疫苗类型。
