• Diane M Harper, Eduardo L Franco, Cosette Wheeler, Daron G Ferris, David Jenkins, Anne Schuind, Toufik Zahaf, Bruce Innis, Paulo Naud, Newton S De Carvalho, Cecilia M Roteli-Martins, Julio Teixeira, Mark M Blatter, Abner P Korn, Wim Quint, Gary Dubin, and GlaxoSmithKline HPV Vaccine Study Group.
• Department of Obstetrics and Gynecology, Norris Cotton Cancer Center, Dartmouth Medical School, Hanover, NH, USA. diane.m.harper@dartmouth.edu
• Lancet. 2004 Nov 13; 364 (9447): 175717651757-65.

BackgroundVaccination against the most common oncogenic human papillomavirus (HPV) types, HPV-16 and HPV-18, could prevent development of up to 70% of cervical cancers worldwide. We did a randomised, double-blind, controlled trial to assess the efficacy, safety, and immunogenicity of a bivalent HPV-16/18 L1 virus-like particle vaccine for the prevention of incident and persistent infection with these two virus types, associated cervical cytological abnormalities, and precancerous lesions.MethodsWe randomised 1113 women between 15-25 years of age to receive three doses of either the vaccine formulated with AS04 adjuvant or placebo on a 0 month, 1 month, and 6 month schedule in North America and Brazil. Women were assessed for HPV infection by cervical cytology and self-obtained cervicovaginal samples for up to 27 months, and for vaccine safety and immunogenicity.FindingsIn the according-to-protocol analyses, vaccine efficacy was 91.6% (95% CI 64.5-98.0) against incident infection and 100% against persistent infection (47.0-100) with HPV-16/18. In the intention-to-treat analyses, vaccine efficacy was 95.1% (63.5-99.3) against persistent cervical infection with HPV-16/18 and 92.9% (70.0-98.3) against cytological abnormalities associated with HPV-16/18 infection. The vaccine was generally safe, well tolerated, and highly immunogenic.InterpretationThe bivalent HPV vaccine was efficacious in prevention of incident and persistent cervical infections with HPV-16 and HPV-18, and associated cytological abnormalities and lesions. Vaccination against such infections could substantially reduce incidence of cervical cancer.

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