126 Vaccine Protection against Human Papillomaviruses Kathrin U Jansen VaxGen, Inc, Brisbane, CA, USA

Human papillomaviruses (HPVs) infect cutaneous, genital, oral and respiratory epithelia in a tissue-specific manner.  Infection with HPVs is widespread throughout the world, and viral infection is closely associated with both benign and malignant lesions. The causal link of HPV and cervical cancer has been clearly established both from population based studies as well as animal models. HPV types 6 and 11 are responsible for >90% of genital warts in both men and women and ~25% of low-grade cervical intraepithelial lesions (CIN1).  HPV types 16 and 18 cause an additional ~25% of CIN1, and ~70% of all high-grade cervical lesions and cancer. Despite the existence of good screening programs for precursor lesions of cervical cancer in the US, 10,520 women still were diagnosed with cervical cancer in 2004, of which about 50% will likely die from the disease. In developing countries where access to routine cervical cytological screening is nonexistent or difficult, cervical cancer is the second most common malignancy with an estimate of 1.4 million prevalent cases and ~500,000 new cases annually. Because of the viral origin of cervical cancer, many groups have embarked on vaccine development to combat the disease using both therapeutic as well as prophylactic vaccines. Prophylactic vaccines have shown the most promise to date and several groups are in late stage (Phase III) clinical testing. A review of Phase I/II clinical data and very exciting and encouraging proof-of-concept study data will be presented.