Abstract

BackgroundThe quadrivalent human papillomavirus vaccine has been provided in Australia through the National Human Papillomavirus Vaccination Program since April 2007. National registry data demonstrates good coverage of the vaccine, with 73% of school-aged girls having received all three doses. To evaluate the effectiveness of the program, we propose a two-pronged approach. In one (sub study A), the prevalence of the vaccine-targeted human papillomavirus genotypes in a population cohort is being estimated, and will be analysed in relation to vaccination status, cervical cytology screening status, demographic, social, behavioural, medical and clinical factors. In sub study B, the distribution of human papillomavirus genotypes detected in high grade cervical intraepithelial neoplastic lesions from vaccine eligible women is being assessed.Methods/DesignSub Study A involves the recruitment of 1569 women aged 18–25, residing in Victoria, Australia, through Facebook advertising. Women who are sexually active are being asked to provide a self-collected vaginal swab, collected at home and posted into the study centre, where human papillomavirus DNA detection and genotyping is performed. Participants also complete an online questionnaire regarding sexual history, experience with, knowledge of, and attitudes towards human papillomavirus, the human papillomavirus vaccine, and cervical screening.Sub Study B will involve the collection of 500 cervical biopsies, positively identified as containing high grade cervical intraepithelial neoplastic lesions and/or adenocarcinoma in situ. Five serial sections are being taken from each case: sections 1 and 5 are being assessed to confirm the presence of the high grade cervical intraepithelial neoplastic lesions or adenocarcinoma in situ; human papillomavirus genotyping is performed on sections 2 and 3; single lesions are excised from section 4 using laser capture microdissection to specifically define causality of a human papillomavirus genotyping of each specific lesion.DiscussionAustralia is well placed to gain a clear and early insight into the effectiveness of the human papillomavirus vaccine in reducing the prevalence of human papillomavirus infection in young women, and any subsequent reduction in the prevalence of pre-cancerous cervical lesions, specifically high grade cervical intraepithelial neoplasia lesions, particularly of vaccine related types. The findings of a successful population based human papillomavirus program will have wide-reaching translational benefits across the globe.

Highlights

  • The quadrivalent human papillomavirus vaccine has been provided in Australia through the National Human Papillomavirus Vaccination Program since April 2007

  • Study objectives This paper describes a two-pronged approach to assessing the effectiveness of the Australian human papillomavirus (HPV) vaccination program in reducing both the prevalence of vaccine-targeted HPV genotypes in a population cohort; and assessing the proportion of CIN3 cases positive for vaccine-targeted HPV genotypes in a biopsy cohort

  • Beyond the translational benefits to Victoria and Australia, the demonstration of successful ‘real world’ outcomes of a publically funded population based program will be valuable to other countries, especially countries who are not in the position to conduct their own studies, due to low HPV vaccination uptake or the absence of vaccine registries

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Summary

Discussion

Australia is a world leader in the early implementation of HPV vaccine programs, with approximately 83% of eligible females in the target population of 12–13 year olds having had at least one dose of the vaccine, and 73% having completed the 3 dose program [15]. Understanding of the prevalence of HPV genotypes after vaccine implementation in the real world, rather than in the restricted population of phase 3 vaccine trials, will help refine estimates of the eventual impact and costeffectiveness of universal HPV vaccination as a strategy to prevent cervical cancer. This data will be important for refining models of HPV infection and cervical disease to inform the renewal of Australia’s national cervical screening program [36].

Background
Methods
67. Canberra
11. Brotherton JM
61. Canberra
43. Bernard HU
Findings
45. Halpern AL
Full Text
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