Infections with oncogenic types of HPV cause virtually allcases of cervical cancer worldwide. Prophylactic and or combined prophylactic and early therapeutic types ofvaccination against HPV 16 and 18, two of the most important HPV type,could protect against a large majority of the cases ofcervical cancer globally. Vaccines based on the L1 structural protein of HPV which self-assemble intoconformationally-correct virion-like particles (virus-like particles or VLPs) are under study.The immunogenicity and safety of HPV 16 & 18 VLPs have beendemonstrated in Phase 1 and Phase 2 human trials. Evidence also suggest highefficacy of VLP-based vaccines in protecting against type-specific persistent HPV infection. A full-scale Phase 3 randomized controlled trial of an HPV16/18 VLP vaccine has been initiated in Costa Rica. Costa Rica was chosen for the Phase 3 trial becauseof our extensive successful scientific collaborations there,the continued high risk of cervical cancer, the universalmedical system providing national linkage, and the likelihood of very high participation over the many neededyears of close clinical follow-up. Approximately 7,500 women willbe vaccinated according to current plans.In support of the vaccine trials, a variety of methodologicand ancillary projects are underway or planned, that willmaximize the yield of the main effort.
