作者
Luisa L Villa, Ronaldo LR Costa, Carlos A Petta, Rosires P Andrade, Kevin A Ault, Anna R Giuliano, Cosette M Wheeler, Laura A Koutsky, Christian Malm, Matti Lehtinen, Finn Egil Skjeldestad, Sven-Eric Olsson, Margareta Steinwall, Darron R Brown, Robert J Kurman, Brigitte M Ronnett, Mark H Stoler, Alex Ferenczy, Diane M Harper, Gretchen M Tamms, Jimmy Yu, Lisa Lupinacci, Radha Railkar, Frank J Taddeo, Kathrin U Jansen, Mark T Esser, Heather L Sings, Alfred J Saah, Eliav Barr
发表日期
2005/5/1
期刊
The lancet oncology
卷号
6
期号
5
页码范围
271-278
出版商
Elsevier
简介
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 μg type 6, 40 μg type 11, 40 μg type 16, and 20 μg 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 …
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LL Villa, RLR Costa, CA Petta, RP Andrade, KA Ault… - The lancet oncology, 2005