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

Luisa L. Villa, Ronaldo L.R. 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. TammsJimmy Yu, Lisa Lupinacci, Radha Railkar, Frank J. Taddeo, Kathrin U. Jansen, Mark T. Esser, Heather L. Sings, Alfred J. Saah, Eliav Barr

Research output: Contribution to journalArticlepeer-review

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 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 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.

Original languageEnglish (US)
Pages (from-to)271-278
Number of pages8
JournalLancet Oncology
Volume6
Issue number5
DOIs
StatePublished - May 2005

ASJC Scopus subject areas

  • Oncology

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