Review of current knowledge on HPV vaccination: an appendix to the European Guidelines for Quality Assurance in Cervical Cancer Screening.

The recognition of a strong etiological relationship between infection with high-risk human papillomavirusses and cervical cancer has prompted research to develop and evaluate prophylactic and therapeutic vaccines. One prophylactic quadrivalent vaccine using L1 virus-like particles (VLP) of HPV 6, 11, 16 and 18 is available on the European market since the end of 2006 and it is expected that a second bivalent vaccine containing VLPs of HPV16 and HPV18 will become available in 2007. Each year, HPV16 and HPV18 cause approximately 43,000 cases of cervical cancer in the European continent. Results from the phase-IIb and III trials published thus far indicate that the L1 VLP HPV vaccine is safe and well-tolerated. It offers HPV-naive women a very high level of protection against HPV persistent infection and cervical intra-epithelial lesions associated with the types included in the vaccine. HPV vaccination should be offered to girls before onset of sexual activity. While prophylactic vaccination is likely to provide important future health gains, cervical screening will need to be continued for the whole generation of women that is already infected with the HPV types included in the vaccine. Phase IV studies are needed to demonstrate protection against cervical cancer and to verify duration of protection, occurrence of replacement by non-vaccine types and to define future policies for screening of vaccinated cohorts. The European Guidelines on Quality Assurance for Cervical Cancer Screening provides guidance for secondary prevention by detection and management of precursors lesions of the cervix. The purpose of the appendix on vaccination is to present current knowledge. Developing guidelines for future use of HPV vaccines in Europe, is the object of a new grant offered by the European Commission.