| Summary: | Human papillomavirus (HPV) is absolutely required for the development and progression of precancerous lesions in the cervical epithelium, and has been isolated in more than 99% of cervical cancers sampled. Given that the majority (∼70%) of cases of cervical cancer are caused by only two HPV types, appropriately designed vaccines are an attractive proposition for preventing HPV infection and thus, by extension, cervical cancer. Gardasil is a recombinant quadrivalent HPV vaccine comprising a mixture of highly purified virus-like particles (VLPs) of the major capsid protein (L1) derived from HPV types 6, 11, 16 and 18. Gardasil prevents persistent infection by the vaccine HPV types for at least 5 years. More pertinently, in HPV-naïve women, Gardasil provides complete protection against high-grade cervical dysplasia. The vaccine also prevents vulval precancers, reduces the incidence of vaginal precancerous lesions and protects against genital warts caused by the vaccine HPV types. The vaccine stimulates a robust immune response, with serum anti-HPV antibody titres substantially higher than those associated with a natural HPV infection, whilst immune responses in children are non-inferior to those of older adolescents and young women, suggesting that Gardasil also prevents HPV infection in this population. Gardasil is well tolerated with a favourable safety profile. In summary the introduction of Gardasil in conjunction with cervical screening has the potential to substantially reduce the burden of cervical cancer and other HPV-related diseases. © 2008 CSF Medical Communications Ltd.
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