Prophylactic HPV vaccines: new interventions for cancer control.

Human Papillomavirus (HPV) infection causes cervical cancer, a significant portion of anal, vulvar, vaginal, and oropharyngeal cancers, genital warts, and recurrent respiratory papillomatosis (RRP). HPV 16 and 18 cause 70-90% of HPV-related cancers whereas HPV 6 and 11 cause 90% of RRP and genital wart cases. Together these four types cause 30-50% of all cervical intraepithelial neoplasia such as those detected by Papinicalou screening. In June 2006, a quadrivalent HPV (6, 11, 16, 18) vaccine was licensed in the United States, and subsequently in the European Union (September 2006), both following expedited review. We describe the primary objectives of the quadrivalent HPV vaccine clinical trial program including studies in females aged 9-45 and males aged 9-26. Planned long-term efficacy and safety evaluations, as well as programs to evaluate vaccine impact on oropharyngeal cancer are also described.