Effect of the human papillomavirus (HPV) quadrivalent vaccine in a subgroup of women with cervical and vulvar disease: retrospective pooled analysis of trial data.
Effect of the human papillomavirus (HPV) quadrivalent vaccine in a subgroup of women with cervical and vulvar disease: retrospective pooled analysis of trial data.
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DOI：
10.1136/bmj.e1401
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发表时间：
2012-03-27
期刊：
影响因子：
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通讯作者：
FUTURE I and II Study Group
中科院分区：
文献类型：
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作者：
Joura EA;Garland SM;Paavonen J;Ferris DG;Perez G;Ault KA;Huh WK;Sings HL;James MK;Haupt RM;FUTURE I and II Study Group
目的确定人乳头瘤病毒（HPV）四价疫苗对宫颈上皮内瘤变切除术后或诊断为生殖器疣、外阴上皮内瘤变或阴道上皮内瘤变后发生后续疾病风险的影响。设计：回顾性分析来自两项国际、双盲、安慰剂对照、四价HPV疫苗随机有效性试验（方案013（FUTURE I）和方案015（FUTURE II））的数据。在全球24个国家和地区设立初级保健中心和大学或医院相关的保健中心。参与者在17622名年龄在15-26岁的女性中，接受了1：1的疫苗或安慰剂随机分配，其中2054人接受了宫颈手术或被诊断为生殖器疣，外阴上皮内瘤变或阴道上皮内瘤变。干预在第1天、第2个月和第6个月接种三剂四价HPV疫苗或安慰剂。主要结果测量治疗或诊断后60天内HPV相关疾病的发病率，表示为每100人年有终点风险的女性人数。结果共有587名疫苗接种者和763名安慰剂接种者接受了宫颈手术。疫苗和安慰剂接受者中任何后续HPV相关疾病的发生率分别为6.6和12.2（接种疫苗后降低46.2%（95%置信区间22.5%至63.2%））。接种疫苗与任何后续高度宫颈疾病的风险显著降低相关，降低了64.9%（20.1%至86.3%）。共有229名疫苗接种者和475名安慰剂接种者被诊断为生殖器疣、外阴上皮内瘤变或阴道上皮内瘤变，疫苗接种者和安慰剂接种者中任何后续HPV相关疾病的发生率分别为20.1和31.0（降低35.2%（13.8%至51.8%））。结论既往接受过HPV相关疾病手术治疗的妇女接种四价HPV疫苗可显著降低后续HPV相关疾病的发生率，包括高度病变。试验注册NCT 00092521和NCT 00092534
Objectives To determine the effect of human papillomavirus (HPV) quadrivalent vaccine on the risk of developing subsequent disease after an excisional procedure for cervical intraepithelial neoplasia or diagnosis of genital warts, vulvar intraepithelial neoplasia, or vaginal intraepithelial neoplasia. Design Retrospective analysis of data from two international, double blind, placebo controlled, randomised efficacy trials of quadrivalent HPV vaccine (protocol 013 (FUTURE I) and protocol 015 (FUTURE II)). Setting Primary care centres and university or hospital associated health centres in 24 countries and territories around the world. Participants Among 17 622 women aged 15–26 years who underwent 1:1 randomisation to vaccine or placebo, 2054 received cervical surgery or were diagnosed with genital warts, vulvar intraepithelial neoplasia, or vaginal intraepithelial neoplasia. Intervention Three doses of quadrivalent HPV vaccine or placebo at day 1, month 2, and month 6. Main outcome measures Incidence of HPV related disease from 60 days after treatment or diagnosis, expressed as the number of women with an end point per 100 person years at risk. Results A total of 587 vaccine and 763 placebo recipients underwent cervical surgery. The incidence of any subsequent HPV related disease was 6.6 and 12.2 in vaccine and placebo recipients respectively (46.2% reduction (95% confidence interval 22.5% to 63.2%) with vaccination). Vaccination was associated with a significant reduction in risk of any subsequent high grade disease of the cervix by 64.9% (20.1% to 86.3%). A total of 229 vaccine recipients and 475 placebo recipients were diagnosed with genital warts, vulvar intraepithelial neoplasia, or vaginal intraepithelial neoplasia, and the incidence of any subsequent HPV related disease was 20.1 and 31.0 in vaccine and placebo recipients respectively (35.2% reduction (13.8% to 51.8%)). Conclusions Previous vaccination with quadrivalent HPV vaccine among women who had surgical treatment for HPV related disease significantly reduced the incidence of subsequent HPV related disease, including high grade disease. Trial registrations NCT00092521 and NCT00092534