年轻女性预防性四价人乳头瘤病毒（6、11、16和18型）L1病毒样颗粒疫苗：一项随机双盲安慰剂对照多中心II期疗效试验。

Prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in young women: a randomised double-blind placebo-controlled multicentre phase II efficacy trial.

作者信息

Villa Luisa L, Costa Ronaldo L R, Petta Carlos A, Andrade Rosires P, Ault Kevin A, Giuliano Anna R, Wheeler Cosette M, Koutsky Laura A, Malm Christian, Lehtinen Matti, Skjeldestad Finn Egil, Olsson Sven-Eric, Steinwall Margareta, Brown Darron R, Kurman Robert J, Ronnett Brigitte M, Stoler Mark H, Ferenczy Alex, Harper Diane M, Tamms Gretchen M, Yu Jimmy, Lupinacci Lisa, Railkar Radha, Taddeo Frank J, Jansen Kathrin U, Esser Mark T, Sings Heather L, Saah Alfred J, Barr Eliav

机构信息

Department of Virology, Ludwig Institute for Cancer Research, Sao Paulo, Brazil.

出版信息

Lancet Oncol. 2005 May;6(5):271-8. doi: 10.1016/S1470-2045(05)70101-7.

DOI:10.1016/S1470-2045(05)70101-7

PMID:15863374

Abstract

BACKGROUND

A randomised double-blind placebo-controlled phase II study was done to assess the efficacy of a prophylactic quadrivalent vaccine targeting the human papillomavirus (HPV) types associated with 70% of cervical cancers (types 16 and 18) and with 90% of genital warts (types 6 and 11).

METHODS

277 young women (mean age 20.2 years [SD 1.7]) were randomly assigned to quadrivalent HPV (20 microg type 6, 40 microg type 11, 40 microg type 16, and 20 microg type 18) L1 virus-like-particle (VLP) vaccine and 275 (mean age 20.0 years [1.7]) to one of two placebo preparations at day 1, month 2, and month 6. For 36 months, participants underwent regular gynaecological examinations, cervicovaginal sampling for HPV DNA, testing for serum antibodies to HPV, and Pap testing. The primary endpoint was the combined incidence of infection with HPV 6, 11, 16, or 18, or cervical or external genital disease (ie, persistent HPV infection, HPV detection at the last recorded visit, cervical intraepithelial neoplasia, cervical cancer, or external genital lesions caused by the HPV types in the vaccine). Main analyses were done per protocol.

FINDINGS

Combined incidence of persistent infection or disease with HPV 6, 11, 16, or 18 fell by 90% (95% CI 71-97, p<0.0001) in those assigned vaccine compared with those assigned placebo.

INTERPRETATION

A vaccine targeting HPV types 6, 11, 16, 18 could substantially reduce the acquisition of infection and clinical disease caused by common HPV types.

摘要

背景

开展了一项随机双盲安慰剂对照的II期研究，以评估一种预防性四价疫苗的疗效，该疫苗针对的是人乳头瘤病毒（HPV）类型，这些类型导致了70%的宫颈癌（16型和18型）以及90%的尖锐湿疣（6型和11型）。

方法

277名年轻女性（平均年龄20.2岁[标准差1.7]）在第1天、第2个月和第6个月时被随机分配接受四价HPV（6型20微克、11型40微克、16型40微克、18型20微克）L1病毒样颗粒（VLP）疫苗，275名（平均年龄20.0岁[1.7]）被随机分配接受两种安慰剂制剂之一。在36个月内，参与者接受定期妇科检查、宫颈阴道HPV DNA采样、HPV血清抗体检测以及巴氏试验。主要终点是HPV 6、11、16或18型感染合并宫颈或外生殖器疾病（即持续性HPV感染、最后一次记录访视时的HPV检测、宫颈上皮内瘤变、宫颈癌或疫苗中HPV类型引起的外生殖器病变）的发生率。主要分析按方案进行。