Rationale and design of a community-based double-blind randomized clinical trial of an HPV 16 and 18 vaccine in Guanacaste, Costa Rica
Rationale and design of a community-based double-blind randomized clinical trial of an HPV 16 and 18 vaccine in Guanacaste, Costa Rica
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DOI：
10.1016/j.vaccine.2008.07.002
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发表时间：
2008-09-02
期刊：
影响因子：
5.5
通讯作者：
Schiffman, Mark
中科院分区：
文献类型：
--
作者：
Herrero, Rolando;Hildesheim, Allan;Schiffman, Mark
我们报告了在哥斯达黎加两个省进行的HPV16和18型疫苗的社区双盲随机临床试验的基本原理、设计、方法和参与细节，以调查该疫苗在预防宫颈癌先兆方面的有效性和对人群的影响。超过24000名年龄在18岁到25岁之间的妇女被邀请参加并进行了资格预筛，招募了7466名妇女(预筛查者中30%，合格者中59%)，她们被随机接受3剂HPV疫苗或甲型肝炎疫苗作为对照。数据和样本收集采用了复杂的方案，包括面谈、性活跃妇女的盆腔检查、血清学和细胞免疫的血液、局部免疫的宫颈分泌物和HPV、沙眼衣原体和淋病检测的细胞。80%的妇女接受了三剂，12.4%的妇女接受了两剂，7.4%的妇女接受了一剂。在访问时，数据和样本收集的合规性接近100%。报告了HPV和宫颈肿瘤的基线特征和特定年龄段的患病率。HPV的总患病率很高(50%)，HPV16型和18型分别为8.3%和3.2%。基线时12.7%的妇女检出LSLE，1.9%的妇女检出HSIL。衣原体患病率为14.2%。临床医生采集的标本与自身采集的标本检测HPV的符合率为89.4%，kappa为0.59。每名参与者将继续每年或更频繁地进行至少4年的跟踪检查。(C)2008爱思唯尔有限公司。保留所有权利。
We report the rationale, design, methods and details of participation of a community-based, double-blind, randomized clinical trial of an HPV 16 and 18 vaccine conducted in two provinces of Costa Rica to investigate the efficacy and population impact of the vaccine in the prevention of cervical cancer precursors. More than 24,000 women between 18 and 25 years of age were invited to participate and pre-screened for eligibility, with recruitment of 7466 women (30% of those pre-screened, 59% of those eligible) who were randomized to receive 3 doses of the HPV vaccine or hepatitis A vaccine as control. A complex protocol of data and specimen collection was applied, including an interview, pelvic exam for sexually active women, blood for serology and cell-mediated immunity, cervical secretions for local immunity and cells for HPV, Chlamydia trachomatis and gonorrhea testing. Eighty percent of the women received three doses, 12.4% two doses and 7.4% one dose. At visits, compliance with data and specimen collection was close to 100%. Baseline characteristics and age-specific prevalence of HPV and cervical neoplasia are reported. Overall prevalence of HPV was high (50%), with 8.3% of women having HPV 16 and 3.2% HPV 18. LSIL was detected in 12.7% of women at baseline and HSIL in 1.9%. Prevalence of Chlamydia was 14.2%. There was very good agreement in HPV detection between clinician-collected and self-collected specimens (89.4% agreement for all types, kappa 0.59). Follow up will continue with yearly or more frequent examinations for at least 4 years for each participant. (C) 2008 Elsevier Ltd. All rights reserved.