Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases
Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases
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DOI：
10.1056/nejmoa061760
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发表时间：
2007-05-10
影响因子：
158.5
通讯作者：
Koutsky, Laura A.
中科院分区：
文献类型：
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作者：
Garland, Suzanne M.;Hernandez-Avila, Mauricio;Koutsky, Laura A.
背景：进行了一项3期试验，以评估预防性四价疫苗预防与人乳头瘤病毒（HPV） 6、11、16和18型相关的肛门生殖器疾病的疗效。方法：在这项随机、安慰剂对照、双盲试验中，研究人员在第1天、第2个月和第6个月对5455名年龄在16至24岁之间的女性进行了研究，其中2723名女性接受疫苗接种，2732名接受安慰剂治疗。主要的复合终点是生殖器疣、外阴或阴道上皮内瘤变或癌症的发生率以及宫颈上皮内瘤变、原位腺癌或与HPV 6型、11型、16型或18型相关的癌症的发生率。初步分析的数据是收集了在第三次给药后1个月内没有HPV 6型、11型、16型或18型病毒学证据的妇女的每个方案易感人群。结果：这些妇女在第一次给药后平均随访3年。在按方案人群中，外阴、阴道或肛周疾病的随访包括疫苗组2261名妇女（83%）和安慰剂组2279名妇女（83%）。宫颈疾病随访包括2241名妇女（82%）接种疫苗组和2258名妇女（83%）安慰剂组。每个主要终点的疫苗效力均为100%。在一项意向治疗分析中，包括那些由疫苗型和非疫苗型HPV引起的流行感染或疾病的患者，接种疫苗使外阴或阴道肛周病变的发生率降低了34%(95%置信区间[CI]， 15至49)，使宫颈病变的发生率降低了20% （95% CI， 8至31）。结论：四价疫苗显著降低了年轻女性hpv相关肛门生殖器疾病的发病率。
BACKGROUND:A phase 3 trial was conducted to evaluate the efficacy of a prophylactic quadrivalent vaccine in preventing anogenital diseases associated with human papillomavirus (HPV) types 6, 11, 16, and 18.METHODS:In this randomized, placebo-controlled, double-blind trial involving 5455 women between the ages of 16 and 24 years, we assigned 2723 women to receive vaccine and 2732 to receive placebo at day 1, month 2, and month 6. The coprimary composite end points were the incidence of genital warts, vulvar or vaginal intraepithelial neoplasia, or cancer and the incidence of cervical intraepithelial neoplasia, adenocarcinoma in situ, or cancer associated with HPV type 6, 11, 16, or 18. Data for the primary analysis were collected for a per-protocol susceptible population of women who had no virologic evidence of HPV type 6, 11, 16, or 18 through 1 month after administration of the third dose.RESULTS:The women were followed for an average of 3 years after administration of the first dose. In the per-protocol population, those followed for vulvar, vaginal, or perianal disease included 2261 women (83%) in the vaccine group and 2279 (83%) in the placebo group. Those followed for cervical disease included 2241 women (82%) in the vaccine group and 2258 (83%) in the placebo group. Vaccine efficacy was 100% for each of the coprimary end points. In an intention-to-treat analysis, including those with prevalent infection or disease caused by vaccine-type and non-vaccine-type HPV, vaccination reduced the rate of any vulvar or vaginal perianal lesions regardless of the causal HPV type by 34% (95% confidence interval [CI], 15 to 49), and the rate of cervical lesions regardless of the causal HPV type by 20% (95% CI, 8 to 31).CONCLUSIONS:The quadrivalent vaccine significantly reduced the incidence of HPV-associated anogenital diseases in young women.