Dr F. Xavier Bosch (Institut Catala d’Óncologia (ICO), Spain)
Prof. Jack Cuzick (Queen Mary University of London (QMUL), UK)
Since 2008, most European countries have witnessed the introduction of HPV vaccines into routine immunization programmes. Recommendations for the vaccination age are diverse, ranging from 9 to 26 years, although most of them prioritize peri-adolescent age groups to be immunized based on scientific evidence and cost-effectiveness data. Once women vaccinated at adolescence reach screening age, the impact of vaccination on the burden of cervical cancer (and other HPV-related disease) will become apparent. This may take as long as 20 years since the implementation of vaccination programmes.
Recent results of Phase III vaccination trials have documented that vaccine efficacy among adult women (shown to age 45/55) is excellent, provided they are HPV negative at the time of vaccination. Therefore, the European Medicines Agency (EMA) extended the indication of HPV vaccine to women aged 9+ with no upper limit. Consequently, women aged 25-45, who represent approximately 35% of screening-eligible women may still benefit from HPV vaccination. However, HPV vaccination coverage of adult women in Europe is low to very low and there is a limited understanding of the role of vaccination of adult women and its potential impact on the acceleration of the reduction of cervical cancer mortality and on the reduction of subsequent screening visits. Before conducting large-scale effectiveness and implementation trials on adult vaccination, it is advisable to gather additional country-specific information on the acceptability and feasibility of adult vaccination and furthermore to assess vaccination compliance in the context of a free vaccination offered to adult women using the current cervical cancer screening programmes.
For this purpose, a multinational study will be conducted in 11 countries (Spain, UK, the Netherlands , Finland, Sweden , Belgium , Italy , Slovenia , Denmark , France and Germany). Women attending cervical screening visits will be invited to participate. Consenting women will receive a questionnaire on the HPV vaccine. In addition women will receive an acceptability questionnaire on the HPV vaccine. Additionally, those who accept will get 3 HPV vaccine doses.
In total 3000 women aged within the age range of 25-45 years old will be recruited; 250-300 women per country.