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Purpose of Review: In this article, we review the impact of the quadrivalent and bivalent prophylactic human papillomavirus (HPV) vaccines on HPV infection and disease, review alternative vaccine dosing schedules, the vaccination of men and the nine-valent HPV vaccine., Recent Findings: HPV vaccines have had dramatic impacts on the prevalence of targeted HPV types (6,11,16 and 18), genital warts and precancerous cervical lesions. Population coverage would be facilitated by adopting two-dose schedules, with recent findings that two-dose schedules in young adolescents are as immunogenic as three doses in young adults. Extension of vaccination to men, particularly for men who have sex with men, could further reduce population prevalence of HPV and provide direct protection to men against genital warts and anal, penile and oropharyngeal cancers. The nine-valent HPV vaccine has demonstrated equivalent protection against the four types in the quadrivalent vaccine and high efficacy against the next five commonest causes of cervical cancer (HPV types 31,33,45,52 and 58). If cost-effective, it may extend the spectrum of protection against cervical cancer available through vaccination., Summary: HPV vaccination is an effective strategy for reducing the burden of HPV-related disease. New schedules, target populations and vaccines promise to expand this potential further.

Objective: To compare the use of two alternative population-based denominators in calculating HPV vaccine coverage in Australia by age groups, jurisdiction and remoteness areas., Method: Data from the National HPV Vaccination Program Register (NHVPR) were analysed at Local Government Area (LGA) level, by state/territory and by the Australian Standard Geographical Classification Remoteness Structure. The proportion of females vaccinated was calculated using both the ABS ERP and Medicare enrolments as the denominator., Results: HPV vaccine coverage estimates were slightly higher using Medicare enrolments than using the ABS estimated resident population nationally (70.8% compared with 70.4% for 12 to 17-year-old females, and 33.3% compared with 31.9% for 18 to 26-year-old females, respectively.) The greatest differences in coverage were found in the remote areas of Australia., Conclusion: There is minimal difference between coverage estimates made using the two denominators except in Remote and Very Remote areas where small residential populations make interpretation more difficult. Adoption of Medicare enrolments for the denominator in the ongoing program would make minimal, if any, difference to routine coverage estimates., (© 2015 Public Health Association of Australia.)

Unlabelled: Background The study evaluated acceptability, invitation letters and the test kit for a trial of human papillomavirus (HPV) self-sampling among never- and under-screened women in Australia., Methods: Victorian women, 30-69 years, who had never had a Pap test or were overdue for one, participated. Four focus groups including eight to nine participants segmented by age (30-49 and 50-69 years) and screening history (never- and under-screened) were conducted in August 2013. Discussions were recorded and transcribed verbatim and data analysed using thematic content analysis., Results: The response to the concept of HPV self-sampling was positive. Decision-making was largely influenced by the content of a pre-invitation letter. Appealing features of self-sampling were cost (free), convenience (home-based) and anticipated less discomfort (with a swab) than a Pap test. Small kits that fit in mailboxes were preferred over post office parcel collection. The perceived barriers include concerns about test accuracy and lack of confidence that a home-based test would give the same results as a physician administered test. Women wanted information on the timing of receipt of the results and information about the organisation providing the test., Conclusion: HPV self-sampling is a possible alternative for Australian women who are reluctant to have a Pap test and may increase the likelihood of participation in cervical cancer screening if women's concerns about it can be addressed. The findings of this study are relevant for researchers, policymakers and practitioners implementing self-sampling for under-screened women as part of cervical screening programs.

Background: For human papillomavirus (HPV) DNA detection, specimen collection and transportation using a dry swab without transport medium has advantages, in various situations, over liquid media., Objective: In this pilot study we evaluated whether a dry cervical sample taken with a flocked swab (dry sample) is a valid alternative for HPV DNA testing compared with the standard practice of a wet sample taken with a cyto-broom placed directly into liquid media (wet sample)., Study Design: Women attending the dysplasia clinic at the Royal Women's Hospital, Melbourne Australia between November 2013 and February 2014 were enrolled. During colposcopic examination, a practitioner collected wet and dry cervical samples, with the order of collection randomised. In the laboratory both samples were left for a week before being tested for 14 high-risk HPV types using the Roche Cobas 4800 test., Results: Overall, 209 had valid HPV results from both samples. The observed agreement for HPV detection between wet and dry samples was 92.8% and kappa was 0.85 (95% confidence interval (95% CI): 0.78-0.92). There was no statistical difference in the percent HPV positive for each sample (p = 0.30). HPV testing of the dry sample had an 88.5% (95% CI: 79.9-94.3%) sensitivity for HPV detected using the wet specimen. For the HPV results categorized hierarchically, there was 92.8% overall agreement and a kappa of 0.87 (95% CI = 0.80-0.93) for the paired results., Conclusion: Using dry flocked swabs to collect cervical cells is a valid alternative to collecting wet samples for HPV DNA testing using a PCR based test., (Copyright © 2015 Elsevier B.V. All rights reserved.)

Unlabelled: Background The prevalence of human papillomavirus (HPV) at the cervix varies with age, peaking following sexual debut and declining thereafter in most populations. In some populations, a second peak is observed. Here we describe the prevalence of HPV at the cervix among Australian women before the commencement of the HPV vaccination program., Methods: Women aged 15 to 60 years attending health services for cervical screening between 2005 and 2008 were invited to participate. Liquid based cervical specimens were tested for 37 types of HPV using linear array. The percentage and 95% confidence interval of women with any type of HPV, any of 13 high risk HPV types, and with vaccine-preventable HPV types (types 6, 11, 16 and 18) were estimated in 5-year age bands., Results: Among 1929 women aged 15-60 years, HPV prevalence peaked at 64% at age 15-20 years, then declined gradually to 12% at age 41-45 years, whereafter it rose to 19% in women 51-55 years then returned to 14% in 56-60 year olds. Prevalence curves were similar for high-risk HPV types and vaccine-targeted HPV types 6, 11, 16 and 18 and when results were restricted to women with only normal cytology., Conclusions: The shape of the prevalence curve we observed is similar to those from other Western populations. Variation in prevalence curves is likely due to differences in sexual behaviour between populations and over time, reactivation of HPV during perimenopause, and possibly the presence of cervical screening programs. These data are the first such data from the Oceania region.

Background: Human papillomavirus (HPV) vaccination programmes were first implemented in several countries worldwide in 2007. We did a systematic review and meta-analysis to assess the population-level consequences and herd effects after female HPV vaccination programmes, to verify whether or not the high efficacy reported in randomised controlled clinical trials are materialising in real-world situations., Methods: We searched the Medline and Embase databases (between Jan 1, 2007 and Feb 28, 2014) and conference abstracts for time-trend studies that analysed changes, between the pre-vaccination and post-vaccination periods, in the incidence or prevalence of at least one HPV-related endpoint: HPV infection, anogenital warts, and high-grade cervical lesions. We used random-effects models to derive pooled relative risk (RR) estimates. We stratified all analyses by age and sex. We did subgroup analyses by comparing studies according to vaccine type, vaccination coverage, and years since implementation of the vaccination programme. We assessed heterogeneity across studies using I(2) and χ(2) statistics and we did trends analysis to examine the dose-response association between HPV vaccination coverage and each study effect measure., Findings: We identified 20 eligible studies, which were all undertaken in nine high-income countries and represent more than 140 million person-years of follow-up. In countries with female vaccination coverage of at least 50%, HPV type 16 and 18 infections decreased significantly between the pre-vaccination and post-vaccination periods by 68% (RR 0·32, 95% CI 0·19-0·52) and anogenital warts decreased significantly by 61% (0·39, 0·22-0·71) in girls 13-19 years of age. Significant reductions were also recorded in HPV types 31, 33, and 45 in this age group of girls (RR 0·72, 95% CI 0·54-0·96), which suggests cross-protection. Additionally, significant reductions in anogenital warts were also reported in boys younger than 20 years of age (0·66 [95% CI 0·47-0·91]) and in women 20-39 years of age (0·68 [95% CI 0·51-0·89]), which suggests herd effects. In countries with female vaccination coverage lower than 50%, significant reductions in HPV types 16 and 18 infection (RR 0·50, 95% CI 0·34-0·74]) and in anogenital warts (0·86 [95% CI 0·79-0·94]) occurred in girls younger than 20 years of age, with no indication of cross-protection or herd effects., Interpretation: Our results are promising for the long-term population-level effects of HPV vaccination programmes. However, continued monitoring is essential to identify any signals of potential waning efficacy or type-replacement., Funding: The Canadian Institutes of Health Research., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Background: Australia was the first country to implement a government-funded National Human Papillomavirus (HPV) Vaccination Programme. We assessed HPV vaccine uptake comparing self-reported and Register validated estimates, and the knowledge and attitudes of young women with regards to HPV vaccination post-implementation of the programme., Methods: Females, aged 16-25 years living in Victoria, Australia, were recruited using targeted advertising on Facebook from May to September 2010, to complete a web-based questionnaire., Results: Geographic distribution, Indigenous and socio-economic status of the 278 participants were representative of the target population. Overall, 210/278 (76%) had heard of HPV vaccines, with 162/278 (58%) reporting receipt of at least one dose of vaccine, and 54 (19%) unsure. Verification of HPV vaccination status of 142 consenting participants (51%) showed 71% had received at least one dose. Main reasons for vaccination were for protection against HPV infection and cervical cancer (96%) and because it was free (87%), whereas unvaccinated women were uncertain of their eligibility (50%), concerned about adverse reactions (32%), or perceived that vaccination was not needed if they were monogamous (32%)., Conclusion: The potential utility of a vaccination register in the context of a national programme is apparent from the large proportion of young women who were unsure of their vaccine status. HPV vaccine knowledge among participants was relatively high suggesting the national programme has successfully communicated to the majority of eligible women, the purpose and limitations of the vaccine. Vigilance is needed to ensure that young women follow through with Pap testing in vaccine eligible cohorts. The ongoing vaccination programme for pre-adolescent girls and boys should communicate to parents that those with one sexual partner can still acquire HPV and that the safety of the vaccine is now well demonstrated., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

Objectives: Following the implementation of Australia's National HPV Vaccination Program in April 2007, this study evaluated the prevalence of vaccine-targeted human papillomavirus (HPV) genotypes (HPV 6, 11, 16, 18) amongst vaccine-eligible young women., Methods: Between September 2011 and August 2013, women from Victoria, Australia aged 18-25 were recruited through targeted advertising on the social networking website Facebook. Participants completed an online questionnaire, and sexually active women were asked to provide a self-collected vaginal swab for HPV deoxyribonucleic acid (DNA) detection and genotyping. Samples positive for HPV were genotyped using the Linear Array HPV genotyping test (Roche Diagnostics). Self-reported HPV vaccination details were verified with the National HPV Vaccination Program Register (NHVPR)., Results: Of 431 vaginal swabs, 24.8% were positive for HPV DNA. Vaccine-targeted HPV genotypes were detected in only seven (1.6%) samples; all HPV 16 (of the six HPV 16 positive vaccinated women, all had received the vaccine after sexual debut). There were no cases of HPV 6, 11 or 18 identified. HPV types 51, 59, 73, 84, and 89 were the most prevalent genotypes. Vaccination rates were high, with 77.3% of participants having received all three doses of the vaccine, and there was an 89.8% concordance between self-reported and registry-reported HPV vaccination status. Strong associations were observed between vaccination status, age, language spoken at home and country of birth, as well as between HPV detection and the number of male sexual partners., Conclusion: Preliminary data from this study demonstrate a very low prevalence of vaccine-related HPV genotypes amongst vaccine-eligible women from Victoria, Australia. We were able to use Facebook to effectively reach and recruit young women to participate in the assessment of the impact of Australia's HPV vaccination program., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

The development of efficacious prophylactic human papillomavirus vaccines provided an opportunity for the primary prevention of related infections and diseases. Certain oncogenic human papillomaviruses that preferentially infect the genital epithelium cause cervical cancer and a substantial proportion of anal, penile, vaginal, vulvar and oropharyngeal cancers. Following extensive clinical trials demonstrating their efficacy and safety, two vaccines have been in global use for over 6 years. This review summarises the accumulated evidence regarding their high level of efficacy, safety in population usage, reductions in genital warts, infections and cervical disease following their adoption, and facilitators and barriers to achieving high vaccination coverage. The review also discusses practical issues and frequently asked questions regarding duration of effect, vaccination of women treated for cervical disease and alternate vaccination schedules, as well as the need to review cervical screening strategies in the post- vaccination environment., (© 2014 The Author. Journal of Paediatrics and Child Health © 2014 Paediatrics and Child Health Division (Royal Australasian College of Physicians).)

Objectives: Australia introduced a nationwide human papillomavirus (HPV) vaccination programme for women aged 12-26 years in 2007 and has implemented various chlamydia control strategies over the last 10 years. We compared reported diagnoses of warts and chlamydia in two national population-based samples surveyed 10 years apart., Methods: An Australia-wide survey of women aged 18-39 years was conducted by random-digit dialling mobile phone numbers in 2011. The proportion of women self-reporting genital warts and chlamydia was compared with that in equivalent-aged women interviewed in another national telephone survey conducted 10 years earlier using logistic regression adjusting for age, and other factors., Results: 2394 women were included in the 2011 survey. 88 (3.7%) reported a genital warts diagnosis, and 127 (5.3%) had at least one chlamydia diagnosis. For women with warts and chlamydia, the majority were seen in general practice (63.3% and 70.0%, respectively). Comparing women surveyed in 2011 to 4874 women surveyed in 2001, among women eligible for free HPV vaccine through the national programme (women aged 18-30 years), there was a 41% decrease in warts (adjusted OR 0.59, 95% CI 0.39 to 0.89) but among ineligible women (31-39 years) there was a 64% increase (aOR 1.64, 95% CI 1.05 to 2.54). Over the same period chlamydia diagnoses increased by 97% (aOR 1.97, 95% CI 1.15 to 3.37) in women aged 18-24 years., Conclusions: Our results add to evidence from clinic-based studies showing a significant reduction in genital warts among HPV vaccine-eligible women in the general community and increases in the proportion of Australian women diagnosed with chlamydia., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Background: After the introduction of a quadrivalent human papillomavirus (HPV) vaccination programme in Australia in April, 2007, we measured the prevalence of vaccine-targeted and closely related HPV types with the aim of assessing direct protection, cross-protection, and herd immunity., Methods: In this repeat cross-sectional study, we recruited women aged 18-24 years who attended Pap screening between October, 2005, and July, 2007, in three major metropolitan areas of Australia to form our prevaccine-implementation sample. For our postvaccine-implementation sample, we recruited women aged 18-24 years who attended Pap screening in the same three metropolitan areas from August, 2010, to November, 2012. We compared the crude prevalence of HPV genotypes in cervical specimens between the prevaccine and the postvaccine implementation groups, with vaccination status validated against the National HPV Vaccination Program Register. We estimated adjusted prevalence ratios using log linear regression. We estimated vaccine effectiveness both for vaccine-targeted HPV types (16, 18, 6, and 11) and non-vaccine but related HPV types (31, 33, and 45)., Findings: 202 women were recruited into the prevaccine-implementation group, and 1058 were recruited into the postvaccine-implementation group. Crude prevalence of vaccine-targeted HPV genotypes was significantly lower in the postvaccine-implementation sample than in the prevaccine-implementation sample (58 [29%] of 202 vs 69 [7%] of 1058; p<0·0001). Compared with the prevaccine-implementation sample, adjusted prevalence ratios for vaccine-targeted HPV genotypes were 0·07 (95% CI 0·04-0·14; p<0·0001) in fully vaccinated women and 0·65 (0·43-0·96; p=0·03) in unvaccinated women, which suggests herd immunity. No significant declines were noted for non-vaccine-targeted HPV genotypes. However, within the postvaccine-implementation sample, adjusted vaccine effectiveness against vaccine-targeted HPV types for fully vaccinated women compared with unvaccinated women was 86% (95% CI 71-93), and was 58% (26-76) against non-vaccine-targeted but related genotypes (HPV 31, 33, and 45)., Interpretation: 6 years after the initiation of the Australian HPV vaccination programme, we have detected a substantial fall in vaccine-targeted HPV genotypes in vaccinated women; a lower prevalence of vaccine-targeted types in unvaccinated women, suggesting herd immunity; and a possible indication of cross-protection against HPV types related to the vaccine-targeted types in vaccinated women., Funding: Australian National Health and Medical Research Council and Cancer Council Victoria., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

Objective: To determine whether HPV vaccine coverage in 12-13-year-olds varies by geographical area, remoteness and ecological level indicators of socioeconomic status (SES)., Method: Data from the National HPV Vaccination Program Register (NHVPR) were analysed at Statistical Local Area (SLA) level, by the Index of Relative Disadvantage (IRSD) and the Australian Standard Geographical Classification Remoteness Structure., Results: Nationally, 73% of females aged 12-13 years in 2007 were fully vaccinated against HPV. Coverage in low SES areas (71.5%) was 4.1 percentage points lower than coverage in high SES areas (75.6%). Uptake of the first two doses was higher in the very remote parts of Australia (dose 1 - 88.5%, dose 2 - 81.8%) than in major cities (dose 1 - 83.4%, dose 2 - 80.2%), but not for dose 3 where coverage in major cities was 3% higher (73.6% versus 71.4%)., Conclusion: Notifications of HPV vaccine doses delivered to females aged 12-13 through schools suggest a high and relatively equal uptake across socioeconomic groups. Females in remote regions have the highest uptake of dose 1 but are least likely to complete the course. This may be due to particular challenges in vaccine delivery to residents of remote areas., (© 2014 Public Health Association of Australia.)

This, the 6th annual immunisation coverage report, documents trends during 2012 for a range of standard measures derived from Australian Childhood Immunisation Register (ACIR) data, and National Human Papillomavirus (HPV) Vaccination Program Register data. These include coverage at standard age milestones and for individual vaccines included on the National Immunisation Program (NIP) and coverage in adolescents and adults. The proportion of Australian children 'fully vaccinated' at 12, 24 and 60 months of age was 91.7%, 92.5% and 91.2%, respectively. For vaccines available on the NIP but not assessed during 2012 for 'fully vaccinated' status or for eligibility for incentive payments (rotavirus and pneumococcal at 12 months and meningococcal C and varicella at 24 months) coverage varied. Although pneumococcal vaccine had similar coverage at 12 months to other vaccines, coverage was lower for rotavirus at 12 months (83.6%) and varicella at 24 months (84.4%). Although 'fully vaccinated' coverage at 12 months of age was lower among Indigenous children than non-Indigenous children in all jurisdictions, the extent of the difference varied, reaching a 15 percentage point differential in South Australia but only a 0.4 percentage point differential in the Northern Territory. Overall, Indigenous coverage at 24 months of age exceeded that at 12 months of age nationally and for all jurisdictions, but as receipt of varicella vaccine at 18 months is excluded from calculations, this represents delayed immunisation, with some contribution from immunisation incentives. The 'fully vaccinated' coverage estimates for vaccinations due by 60 months of age for Indigenous children exceeded 90% at 91% in 2012. Unlike in 2011, at 60 months of age, there was no dramatic variation in coverage between Indigenous and non-Indigenous children for individual jurisdictions. As previously documented, vaccines recommended for Indigenous children only, hepatitis A and pneumococcal vaccine, had suboptimal coverage at 60.1% and 73.1%, respectively, although there was a considerable improvement in coverage from 2011, 57.7% and 68.2% respectively. On-time receipt (before 49 months of age) of vaccines by Indigenous children at the 60-month milestone age improved substantially between 2011 (19%) and 2012 (38%) but the disparity in on-time vaccination between Indigenous and non-Indigenous children worsened at the 60-month age milestone from 2011 (from 1.8 to 5.4 percentage points) and remained the same for the 12 and 24-month age milestones. By late 2012, the percentage of children who received the 1st dose of DTPa vaccine dose at less than 8 weeks of age was greater than 50% in all but 1 jurisdiction and greater than 70% for New South Wales, the Australian Capital Territory and Tasmania. Further, by late 2012, the percentage of children who received the 4th dose of DTPa vaccine dose at less than 4 years of age was greater than 30% in 3 jurisdictions. The percentage of children whose parents officially objected to vaccination in Australia was 1.7% and this figure varied by jurisdiction. However, there is a further 2.1% of children whose parents don't officially object but whose children have no vaccines recorded on the ACIR. Coverage data for the 3rd dose of HPV from the national HPV register in the school catch up program was similar to 2011 at 71% but was substantially lower for the catch up program for females outside school (44%-69%), although this was an improvement from 2011.

Objective: To compare cervical screening rates for women vaccinated with a quadrivalent human papillomavirus (HPV) vaccine with those for unvaccinated women, to address concerns that vaccinated women may not be participating in cervical screening., Design, Setting and Participants: Cross-sectional analysis of linked data from the Victorian Cervical Cytology Registry and the National HPV Vaccination Program Register for 20-29-year-old women in Victoria, Australia, for the period 1 January 2009 to 31 December 2011., Main Outcome Measures: Screening participation rates for vaccinated and unvaccinated women., Results: Participation in cervical screening during the 2-year period 2010-2011 was significantly lower in 20-24-year-old vaccinated women compared with unvaccinated women of the same age (37.6% v 47.7%, a 10.1 percentage point difference [95% CI, 9.7-10.6]; P < 0.001) and significantly lower in 25-29-year-old vaccinated women compared with unvaccinated women of the same age (45.2% v 58.7%, a 13.5 percentage point difference [95% CI, 13.1%-13.9%]; P < 0.001). Similar results were observed for participation during the 3-year period 2009-2011., Conclusions: Despite education messages provided to young women, our results suggest that vaccinated women are being screened at lower rates than unvaccinated women in Australia. While some degree of undermatching of women in the study may have occurred, this cannot wholly explain our findings. Effective implementation of Individual Healthcare Identifiers to health records, including registry records, is needed to prevent potential undermatching of individuals in future linkage studies. In the meantime, efforts to increase participation in cervical screening by vaccinated women are needed.

Objectives: This study aimed to determine human papillomavirus (HPV) genotypes present in biopsy sections from young women of vaccine eligible age living in Victoria, Australia, with confirmed cervical intraepithelial neoplasia grade 3 (CIN3) or adenocarcinoma in situ (AIS) using laser capture microdissection (LCM)., Methods: Histologically confirmed CIN3 or AIS positive biopsies from vaccine eligible women (born after 30th June 1981, n=169), between May 2011 and March 2013, were identified. CIN3 or AIS lesions were isolated from biopsy material using LCM, and the HPV genotypes present in whole tissue sections (WTS) as well as LCM-isolated lesion tissue were determined by a sensitive reverse hybridisation assay; RHA kit HPV SPF10-LiPA25, version 1 (Labo Bio-medical Products, Rijswijk, The Netherlands)., Results: One hundred and sixty-eight cases were shown to be HPV positive (99%), of which 20 (12%) had more than one HPV genotype detected using WTS-PCR. Evaluation by LCM of individual biopsies with mixed infections showed 18 cases (90%) had only one HPV genotype associated with each CIN3 lesion. HPV 16 was the most common HPV type, found in 95/168 cases (57%)., Conclusion: LCM-PCR allowed us to confirm the presence of a single HPV genotype associated with each biologically separate CIN3 lesion, supporting the theory that only one virus type causes each independent CIN lesion. LCM will provide an important tool in assessing vaccine effectiveness in HPV vaccine programs., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

Background: Data on the prevalence of cervical HPV genotypes in Australia by age and by grade of cytological abnormality are sparse., Objective: Measure prevalence of HPV genotypes among 2620 Australian women by age and cytology status., Study Design: Women presenting for routine Pap smear screening were recruited from diverse regions, including a significant sample of Indigenous women. DNA extracts prepared from Thinprep specimens were HPV genotyped by Roche LINEAR ARRAY HPV., Results: HPV prevalence and genotype distribution were stratified by age (mean 32.6y) and Pap smear result (cytology normal in 86.7%). Overall HPV prevalence was 38.7% with high-risk HPV prevalence of 26.5%. Prevalence of HPV (66.3% in women<21y to 15.3% in women>40y), multiple HPV infection (45.5% in <21y to 5.8% in >40y) and vaccine-targeted genotypes (HPV 6/11/16/18) (34.1% in <21y to 2.4% in >40y) declined significantly with age. The six most common genotypes were: HPV 16 (8.3%), 51 (5.1%), 53 (4.7%), 62 (4.3%), 89 (3.9%) and 52 (3.8%). HR-HPV prevalence increased from 21.1% in women with normal cytology to 80.9% in those with cytologically predicted high-grade abnormalities (HGAs) (p<0.001). The most common genotypes in women with HGAs were HPV 16 (51.1%), 18 (14.9%), 52 (12.8%), 31 (10.6%), and 33 (10.6%): all HR-types., Conclusion: Pre-vaccination cross-sectional prevalence of HR-HPV infection was high in this sample of Australian women attending for screening. HPV 16 was the commonest high-risk type detected at all ages and cytological grades., (Copyright © 2014 Elsevier B.V. All rights reserved.)

Background: Organized screening based on Pap tests has substantially reduced deaths from cervical cancer in many countries, including Australia. However, the impact of the program depends upon the degree to which women participate. A new method of screening, testing for human papillomavirus (HPV) DNA to detect the virus that causes cervical cancer, has recently become available. Because women can collect their own samples for this test at home, it has the potential to overcome some of the barriers to Pap tests. The iPap trial will evaluate whether mailing an HPV self-sampling kit increases participation by never- and under-screened women within a cervical screening program., Methods/design: The iPap trial is a parallel randomized controlled, open label, trial. Participants will be Victorian women age 30-69 years, for whom there is either no record on the Victorian Cervical Cytology Registry (VCCR) of a Pap test (never-screened) or the last recorded Pap test was between five to fifteen years ago (under-screened). Enrolment information from the Victorian Electoral Commission will be linked to the VCCR to determine the never-screened women. Variables that will be used for record linkage include full name, address and date of birth. Never- and under-screened women will be randomly allocated to either receive an invitation letter with an HPV self-sampling kit or a reminder letter to attend for a Pap test, which is standard practice for women overdue for a test in Victoria. All resources have been focus group tested. The primary outcome will be the proportion of women who participate, by returning an HPV self-sampling kit for women in the self-sampling arm, and notification of a Pap test result to the Registry for women in the Pap test arm at 3 and 6 months after mailout. The most important secondary outcome is the proportion of test-positive women who undergo further investigations at 6 and 12 months after mailout of results., Discussion: The iPap trial will provide strong evidence about whether HPV self-sampling could be used in Australia to improve participation in cervical screening for never-and under-screened women., Trial Registration: ANZCTR Identifier: ACTRN12613001104741; UTN: U1111-1148-3885.

Objective: To measure the effectiveness of the quadrivalent human papillomavirus (HPV) vaccine against cervical abnormalities four years after implementation of a nationally funded vaccination programme in Queensland, Australia., Design: Case-control analysis of linked administrative health datasets., Setting: Queensland, Australia., Participants: Women eligible for free vaccination (aged 12-26 years in 2007) and attending for their first cervical smear test between April 2007 and March 2011. High grade cases were women with histologically confirmed high grade cervical abnormalities (n = 1062) and "other cases" were women with any other abnormality at cytology or histology (n = 10,887). Controls were women with normal cytology (n = 96,404)., Main Outcome Measures: Exposure odds ratio (ratio of odds of antecedent vaccination (one, two, or three vaccine doses compared with no doses) among cases compared with controls), vaccine effectiveness ((1-adjusted odds ratio) × 100), and number needed to vaccinate to prevent one cervical abnormality at first screening round. We stratified by four age groups adjusted for follow-up time, year of birth, and measures of socioeconomic status and remoteness. The primary analysis concerned women whose first ever smear test defined their status as a case or a control., Results: The adjusted odds ratio for exposure to three doses of HPV vaccine compared with no vaccine was 0.54 (95% confidence interval 0.43 to 0.67) for high grade cases and 0.66 (0.62 to 0.70) for other cases compared with controls with normal cytology, equating to vaccine effectiveness of 46% and 34%, respectively. The adjusted numbers needed to vaccinate were 125 (95% confidence interval 97 to 174) and 22 (19 to 25), respectively. The adjusted exposure odds ratios for two vaccine doses were 0.79 (95% confidence interval 0.64 to 0.98) for high grade cases and 0.79 (0.74 to 0.85) for other cases, equating to vaccine effectiveness of 21%., Conclusion: The quadrivalent HPV vaccine conferred statistically significant protection against cervical abnormalities in young women who had not started screening before the implementation of the vaccination programme in Queensland, Australia.

Background: Accurate estimates of coverage are essential for estimating the population effectiveness of human papillomavirus (HPV) vaccination. Australia has a purpose built National HPV Vaccination Program Register for monitoring coverage, however notification of doses administered to young women in the community during the national catch-up program (2007-2009) was not compulsory. In 2011, we undertook a population-based mobile phone survey of young women to independently estimate HPV vaccination coverage., Methods: Randomly generated mobile phone numbers were dialed to recruit women aged 22-30 (age eligible for HPV vaccination) to complete a computer assisted telephone interview. Consent was sought to validate self reported HPV vaccination status against the national register. Coverage rates were calculated based on self report and weighted to the age and state of residence structure of the Australian female population. These were compared with coverage estimates from the register using Australian Bureau of Statistics estimated resident populations as the denominator., Results: Among the 1379 participants, the national estimate for self reported HPV vaccination coverage for doses 1/2/3, respectively, weighted for age and state of residence, was 64/59/53%. This compares with coverage of 55/45/32% and 49/40/28% based on register records, using 2007 and 2011 population data as the denominators respectively. Some significant differences in coverage between the states were identified. 20% (223) of women returned a consent form allowing validation of doses against the register and provider records: among these women 85.6% (538) of self reported doses were confirmed., Conclusions: We confirmed that coverage rates for young women vaccinated in the community (at age 18-26 years) are underestimated by the national register and that under-notification is greater for second and third doses. Using 2011 population estimates, rather than estimates contemporaneous with the program rollout, reduces register-based coverage estimates further because of large population increases due to immigration since the program., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

This, the 5th annual immunisation coverage report, documents trends during 2011 for a range of standard measures derived from Australian Childhood Immunisation Register data, and National Human Papillomavirus (HPV) Vaccination Program Register data. The proportion of children 'fully vaccinated' at 12, 24 and 60 months of age was 91.4%, 92.2% and 89.5% respectively. Although pneumococcal vaccine had similar coverage at 12 months to other vaccines, coverage was lower for rotavirus at 12 months (83.8%) and varicella at 24 months (83.9%). By late 2011, the percentage of children who received the 1st dose of DTPa vaccine dose at less than 8 weeks of age was greater than 50% in 3 jurisdictions, the Australian Capital Territory, Victoria, and Queensland and at 70% for New South Wales and Tasmania. Although coverage at 12 months of age was lower among Indigenous children than non-Indigenous children in all jurisdictions, the extent of the difference varied. Overall, coverage at 24 months of age exceeded that at 12 months of age nationally. At 60 months of age, there was dramatic variation between individual jurisdictions, ranging from coverage 8% lower in Indigenous children in South Australia to 6% higher in the Northern Territory. As previously documented, vaccines recommended for Indigenous children only (hepatitis A and pneumococcal polysaccharide vaccine) had suboptimal coverage at 60% and 68%, respectively. On-time receipt (before 49 months of age) of vaccines by Indigenous children at the 60-month milestone age improved between 2010 (18%) and 2011 (19%) but the disparity in on-time vaccination between Indigenous and non-Indigenous children increased at all 3 age milestones. The percentage of vaccine objectors in 2011 (1.7%) has increased from 2007 when it was 1.1%. Coverage data for the 3rd dose of HPV from the national HPV register in the school catch up program was 71% but was substantially lower for the catch-up program for women outside school (39%-67%), although this was an improvement from 2010., (This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any process without prior written permission from the Commonwealth. Requests and inquiries concerning reproduction and rights should be addressed to the Commonwealth Copyright Administration, Attorney General's Department, Robert Garran Offices, National Circuit, Barton ACT 2600 or posted at http://www.ag.gov.au/cca.)

Objective: To describe quadrivalent human papillomavirus (HPV) vaccination coverage achieved in the HPV vaccination catch-up program for girls aged 12-17 years., Design: Analysis of data from the Australian National HPV Vaccination Program Register., Participants: Girls aged 12-17 years as at 30 June 2007., Main Outcome Measures: HPV vaccine coverage by dose (1, 2 and 3), age and state of residence, using Australian Bureau of Statistics estimates of resident populations as the denominator., Results: Notified vaccination coverage for girls aged 12-17 years nationally was 83% for dose 1, 78% for dose 2 and 70% for dose 3. The Australian Capital Territory and Victoria recorded the highest three-dose coverage for the 12-17-year-old cohort overall at 75%. The highest national three-dose coverage rate by age was achieved in 12-year-olds (74%). In Queensland, coverage among Indigenous girls compared with non-Indigenous girls was lower with each dose (lower by 4% for dose 1, 10% for dose 2 and 15% for dose 3). This pattern was not seen in the NT, where initial coverage was 17% lower among Indigenous girls, but the course completion rate among those who started vaccination was identical (84%)., Conclusions: The catch-up HPV vaccination program delivered over 1.9 million doses of HPV vaccine to girls aged 12-17 years, resulting in 70% of girls in this age group being fully vaccinated. The range in coverage achieved and the lower uptake documented among Indigenous girls suggest that HPV vaccination programs can be further improved.

Background: Australia was one of the first countries to introduce a publicly funded national human papillomavirus (HPV) vaccination program that commenced in April 2007, using the quadrivalent HPV vaccine targeting 12- to 13-year-old girls on an ongoing basis. Two-year catch-up programs were offered to 14- to 17- year-old girls in schools and 18- to 26-year-old women in community-based settings. We present data from the school-based program on population-level vaccine effectiveness against cervical abnormalities in Victoria, Australia., Methods: Data for women age-eligible for the HPV vaccination program were linked between the Victorian Cervical Cytology Registry and the National HPV Vaccination Program Register to create a cohort of screening women who were either vaccinated or unvaccinated. Entry into the cohort was 1 April 2007 or at first Pap test for women not already screening. Vaccine effectiveness (VE) and hazard ratios (HR) for cervical abnormalities by vaccination status between 1 April 2007 and 31 December 2011 were calculated using proportional hazards regression., Results: The study included 14,085 unvaccinated and 24,871 vaccinated women attending screening who were eligible for vaccination at school, 85.0% of whom had received three doses. Detection rates of histologically confirmed high-grade (HG) cervical abnormalities and high-grade cytology (HGC) were significantly lower for vaccinated women (any dose) (HG 4.8 per 1,000 person-years, HGC 11.9 per 1,000 person-years) compared with unvaccinated women (HG 6.4 per 1,000 person-years, HGC 15.3 per 1,000 person-years) HR 0.72 (95% CI 0.58 to 0.91) and HR 0.75 (95% CI 0.65 to 0.87), respectively. The HR for low-grade (LG) cytological abnormalities was 0.76 (95% CI 0.72 to 0.80). VE adjusted a priori for age at first screening, socioeconomic status and remoteness index, for women who were completely vaccinated, was greatest for CIN3+/AIS at 47.5% (95% CI 22.7 to 64.4) and 36.4% (95% CI 9.8 to 55.1) for women who received any dose of vaccine, and was negatively associated with age. For women who received only one or two doses of vaccine, HRs for HG histology were not significantly different from 1.0, although the number of outcomes was small., Conclusion: A population-based HPV vaccination program in schools significantly reduced cervical abnormalities for vaccinated women within five years of implementation, with the greatest vaccine effectiveness observed for the youngest women.

Background: The 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/design: Sub 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., Discussion: Australia 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.

Vaccination to prevent human papillomavirus (HPV)-related infection leading to cancer, particularly cervical cancer, is a major public health breakthrough. There are currently two licensed HPV vaccines, both of which contain recombinant virus-like particles of HPV types 16 and 18 (which account for approximately 70 % of cervical cancer). One vaccine also protects against HPV types 6 and 11, which cause genital warts. The safety profile of both vaccines was assessed extensively in randomised controlled clinical trials conducted prior to licensure and has been further elucidated following licensure from surveillance and specific studies in large populations. This review aims to examine current evidence regarding the safety of HPV vaccines. In summary, both vaccines are associated with relatively high rates of injection site reactions, particularly pain, but this is usually of short duration and resolves spontaneously. Systemic reactions have generally been mild and self-limited. Post vaccination syncope has occurred, but can be avoided with appropriate care. Serious vaccine-attributable adverse events, such as anaphylaxis, are rare, and although not recommended for use in pregnancy, abnormal pregnancy outcomes following inadvertent administration do not appear to be associated with vaccination. HPV vaccines are used in a three-dose schedule predominantly in adolescent females: as such case reports linking vaccination with a range of new onset chronic conditions, including autoimmune diseases, have been made. However, well-conducted population-based studies show no association between HPV vaccine and a range of such conditions. Whilst this reassuring safety profile affirms the positive risk benefit of vaccination, as HPV vaccine use expands into more diverse populations, including males, ongoing safety assessment using well-conducted studies is appropriate.

Background: In April 2007, Australia became the first country to introduce a national government-funded human papillomavirus (HPV) vaccination program. We evaluated the program's impact on genotype-specific HPV infection prevalence through a repeat survey of women attending clinical services., Methods: HPV genoprevalence in women aged 18-24 years attending family planning clinics in the prevaccine period (2005-2007) was compared with prevalence among women of the same age group in the postvaccine period (2010-2011). The same recruitment and testing strategies were utilized for both sets of samples, and comparisons were adjusted for potentially confounding variables., Results: The prevalence of vaccine HPV genotypes (6, 11, 16, and 18) was significantly lower in the postvaccine sample than in the prevaccine sample (6.7% vs 28.7%; P < .001), with lower prevalence observed in both vaccinated and unvaccinated women compared with the prevaccine population (5.0% [adjusted odds ratio, 0.11; 95% confidence interval, 0.06-0.21] and 15.8% [adjusted odds ratio, 0.42; 95% confidence interval, 0.19-0.93], respectively). A slightly lower prevalence of nonvaccine oncogenic HPV genotypes was also found in vaccinated women (30.8% vs 37.6%; adjusted odds ratio, 0.68; 95% confidence interval, 0.46-0.99)., Conclusions: Four years after the commencement of the Australian HPV vaccination program, a substantial decrease in vaccine-targeted genotypes is evident and should, in time, translate into reductions in HPV-related lesions.

This editorial describes the contents of this special issue of Sexual Health devoted to anal cancer. The aim of the issue is to provide readers with information to assist them in making decisions about what to do about detecting anal cancer early in men who have sex with men with HIV. Should they be advocating screening? It discusses the epidemiology of HPV infection, anal intraepithelial neoplasia, and anal cancer in MSM, heterosexual men and women; anal cancer screening and treatment of anal cancer. And most importantly, what should be done about vaccinating boys with the HPV vaccine.

Anal cancer was until recently regarded as a rare cancer of little consequence. The articles in this special edition of Sexual Health clearly demonstrate that anal cancer is increasing in incidence and, in some populations, it has become an urgent public health priority. In this summary paper, we will review the data presented in this issue and elsewhere on the magnitude of the issue, the means of prevention and treatment, and suggest a way forward.

The availability of prophylactic human papillomavirus (HPV) vaccines has provided powerful tools for primary prevention of cervical cancer and other HPV-associated diseases. Since 2006, the quadrivalent and bivalent vaccines have each been licensed in over 100 countries. By the beginning of 2012, HPV vaccine had been introduced into national immunization programs in at least 40 countries. Australia, the United Kingdom, the United States, and Canada were among the first countries to introduce HPV vaccination. In Europe, the number of countries having introduced vaccine increased from 3 in 2007 to 22 at the beginning of 2012. While all country programs target young adolescent girls, specific target age groups vary as do catch-up recommendations. Different health care systems and infrastructure have resulted in varied implementation strategies, with some countries delivering vaccine in schools and others through health centers or primary care providers. Within the first 5 years after vaccines became available, few low- or middle-income countries had introduced HPV vaccine. The main reason was budgetary constraints due to the high vaccine cost. Bhutan and Rwanda implemented national immunization after receiving vaccine through donation programs in 2010 and 2011, respectively. The GAVI Alliance decision in 2011 to support HPV vaccination should increase implementation in low-income countries. Evaluation of vaccination programs includes monitoring of coverage, safety, and impact. Vaccine safety monitoring is part of routine activities in many countries. Safety evaluations are important and communication about vaccine safety is critical, as events temporally associated with vaccination can be falsely attributed to vaccination. Anti-vaccination efforts, in part related to concerns about safety, have been mounted in several countries. In the 5 years since HPV vaccines were licensed, there have been successes as well as challenges with vaccine introduction and implementation. Further progress is anticipated in the coming years, especially in low- and middle-income countries where the need for vaccine is greatest. This article forms part of a special supplement entitled "Comprehensive Control of HPV Infections and Related Diseases" Vaccine Volume 30, Supplement 5, 2012., (Published by Elsevier Ltd.)

Aim: We used existing data to investigate whether prevalence of HPV16/18 in cervical intraepithelial neoplasia 3 (CIN3) varies by age, in order to determine whether age specific baseline data is required as the prevaccination comparator for type-specific surveillance following HPV vaccination programs., Materials & Methods: We analyzed available Australian HPV typing data from 317 cervical smears from women with concurrent CIN3 on biopsy and conducted a review and analysis of the international literature., Results: Among 317 women with CIN3, HPV16 was detected in 70% of those 16-25 years old, 59% of 26-35-year-olds and 48% of >36-year-olds (p = 0.025). This association took the form of a trend with decreasing HPV16 prevalence with increasing age (p = 0.007). That HPV16 is commoner in younger women with high-grade cervical lesions was consistent with all but one study of 18 identified in the literature., Conclusion: In screened populations, younger women with CIN3 are more likely to have HPV16 detected. To make valid pre- and post-vaccination comparisons, surveillance specimens for HPV typing should be both age stratified and lesion specific.

Background: Households with fixed-line telephones have decreased while mobile (cell) phone ownership has increased. We therefore sought to examine the feasibility of recruiting young women for a national health survey through random digit dialling mobile phones., Methods: Two samples of women aged 18 to 39 years were surveyed by random digit dialling fixed and mobile numbers. We compared participation rates and responses to a questionnaire between women surveyed by each contact method., Results: After dialling 5,390 fixed-lines and 3,697 mobile numbers, 140 and 128 women were recruited respectively. Among women contacted and found to be eligible, participation rates were 74% for fixed-lines and 88% for mobiles. Taking into account calls to numbers where eligibility was unknown (e.g. unanswered calls) the estimated response rates were 54% and 45% respectively. Of women contacted by fixed-line, 97% reported having a mobile while 61% of those contacted by mobile reported having a fixed-line at home. After adjusting for age, there were no significant differences between mobile-only and fixed-line responders with respect to education, residence, and various health behaviours; however compared to those with fixed-lines, mobile-only women were more likely to identify as Indigenous (OR 4.99, 95%CI 1.52-16.34) and less likely to live at home with their parents (OR 0.09, 95%CI 0.03-0.29)., Conclusions: Random digit dialling mobile phones to conduct a health survey in young Australian women is feasible, gives a comparable response rate and a more representative sample than dialling fixed-lines only. Telephone surveys of young women should include mobile dialling.

Australia commenced an ongoing school based government funded human papillomaviruses (HPV) (cervical cancer prevention) vaccination program in April 2007 for adolescent females aged 12-13 years. In addition, up to December 31, 2009, a catch-up program for young females 13-26 years of age was offered: a school-based vaccination program was used to offer HPV vaccine to girls enrolled in school (14-17 years), and general practitioners or other community health provider offered vaccine to young women aged 18-26 years. To date, only the quadrivalent vaccine (HPV 6/11/16/18) has been utilized in the funded program. Acceptance of the vaccine is high with coverage of 3 doses of the HPV vaccine in the school age cohort around 70%, and just over 30% in the older age cohort. Since the vaccination program was initiated, a reduction in new cases of genital warts of 73% among vaccine eligible age females has been evidenced in STI clinics across Australia. A reduction of 44% of new cases in young males (not a part of the free program) was also documented during this same time period, suggesting significant herd immunity. Similarly, in the state of Victoria, a small but significant decrease in high grade abnormalities in Pap screening findings has been reported in young women<18 years for the period 2007-9, as compared to pre-vaccination. Challenges for the future include how we can sustain and improve HPV vaccination coverage in young Australian women, while maintaining cervical cancer screening participation and reviewing cervical cancer screening methods., (Copyright © 2011. Published by Elsevier Inc.)

Background: Indigenous women in Australia have a disproportionate burden of cervical cancer despite a national cervical screening program. Prior to introduction of a national human papilloma virus (HPV) vaccination program, we determined HPV genotype prevalence by Indigenous status and residence in remote areas., Methods: We recruited women aged 17 to 40 years presenting to community-based primary health services for routine Pap screening across Australia. A liquid-based cytology (LBC) cervical specimen was tested for HPV DNA using the AMPLICOR HPV-DNA test and a PGMY09/11-based HPV consensus PCR; positive specimens were typed by reverse hybridization. We calculated age-adjusted prevalence by weighting to relevant population data, and determined predictors of HPV-DNA positivity by age, Indigenous status and area of residence using logistic regression., Results: Of 2152 women (655 Indigenous), prevalence of the high-risk HPV genotypes was similar for Indigenous and non-Indigenous women (HPV 16 was 9.4% and 10.5%, respectively; HPV 18 was 4.1% and 3.8%, respectively), and did not differ by age group. In younger age groups, the prevalence of other genotypes also did not differ, but in those aged 31 to 40 years, HPV prevalence was higher for Indigenous women (35% versus 22.5%; P < 0.001), specifically HPV clades α5 (OR = 2.1, 95% CI 1.1 to 4.3) and α7, excluding type 18 (OR 1.9, 95% CI 1.1 to 3.3). In multivariate analysis, detection of any HPV genotype was strongly associated with smoking and Pap-test abnormalities, with both risk factors more common among Indigenous women., Conclusion: Although we found no difference in the prevalence of HPV16/18 among Australian women by Indigenous status or, for Indigenous women, residence in remote regions, differences were found in the prevalence of risk factors and some other HPV genotypes. This reinforces the importance of cervical screening as a complement to vaccination for all women, and the value of baseline data on HPV genotype prevalence by Indigenous status and residence for the monitoring of vaccine impact.

Of the 40 types of human papillomavirus that can infect the mucosal epithelium, four types can now be prevented using prophylactic vaccination. Two of these types (high-risk types 16 and 18) cause 70% of cervical cancers, a proportion of other genital cancers and a subset of head and neck cancers. The low-risk types 6 and 11 cause 90% of genital warts and the disease recurrent respiratory papillomatosis. Thus, if primary HPV vaccination programs can be implemented effectively, the potential for a reduction in global disease burden is great. This article considers the current issues and challenges in delivering primary HPV vaccination programs effectively and the likely impact of the vaccines in both the near and more distant future.

Background: Australia introduced a human papillomavirus (HPV) vaccination programme with the quadrivalent HPV vaccine for all women aged 12-26 years between 2007 and 2009. We analysed trends in cervical abnormalities in women in Victoria, Australia, before and after introduction of the vaccination programme., Methods: With data from the Victorian Cervical Cytology Registry between 2003 and 2009, we compared the incidence of histopathologically defined high-grade cervical abnormalities (HGAs, lesions coded as cervical intraepithelial neoplasia of grade 2 or worse or adenocarcinoma in situ; primary outcome) and low-grade cytological abnormalities (LGAs) in five age groups before (Jan 1, 2003, to March 31, 2007) and after (April 1, 2007, to Dec 31, 2009) the vaccination programme began. Binary comparisons between the two periods were done with Fisher's exact test. Poisson piecewise regression analysis was used to compare incident rate trends., Findings: After the introduction of the vaccination programme, we recorded a decrease in the incidence of HGAs by 0·38% (95% CI 0·61-0·16) in girls younger than 18 years. This decrease was progressive and significantly different to the linear trend in incidence before introduction of the vaccination (incident rate ratio 1·14, 1·00-1·30, p=0·05). No similar temporal decline was recorded for LGAs or in older age groups., Interpretation: This is the first report of a decrease in incidence of HGAs within 3 years after the implementation of a population-wide HPV vaccination programme. Linkage between vaccination and screening registers is needed to confirm that this ecological observation is attributable to vaccination and to monitor participation in screening among vaccinated women., Funding: None., (Copyright © 2011 Elsevier Ltd. All rights reserved.)

Accurate estimates of HPV vaccination coverage are critical for determining the proportion of the target female population that is not protected by the vaccine, as well as for monitoring the performance of vaccine delivery programs. The implementation of an HPV vaccination register, either as part of an existing immunisation register or stand-alone, can add substantial benefits to an HPV vaccination program. In Australia, the National HPV Vaccination Program Register supports the HPV vaccination program by providing information to consumers and providers about incomplete courses as well as estimates of vaccination coverage by age and area. Future monitoring of vaccine effectiveness will be facilitated by cross-linking to Pap test registries.

Background: Most anal squamous cell carcinomas (SCCs) are caused by high risk types of human papillomavirus (HPV) and are potentially preventable by HPV vaccination. In order to understand the burden of potentially preventable anal cancer in Australia, we examine the incidence and survival from invasive anal SCC 1982-2005., Methods: We reviewed data on invasive anal cancer cases notified to the National Cancer Statistics Clearing House. Age specific incidence rates of SCC were calculated by year of cancer diagnosis and by birth cohort, and rates of anal adenocarcinoma were included for comparison. Incidence rates were age standardised to the Australian 2001 standard population. Trends in relative survival of SCC were examined., Results: During the study period, a total of 4615 invasive anal cancer cases were diagnosed and most (69.7%) were SCC. Annual incidence of SCC increased almost 50%, from 0.65 to 1.00/100,000. Incidence increased at all ages. The annual rate of increase was almost two-folder higher in men (3.42%, 95% CI 2.49-4.35) than in women (1.88%, 95% CI 1.18-2.58). Five-year relative survival increased by nearly 10% from 58.9% to 68.3% over the last 20 years. Younger patients and women had better survival. For anal adenocarcinoma, increases of borderline significance were seen in men and women., Conclusion: There is an increasing burden of anal SCC in Australia. The group with the highest incidence - homosexual men - are not likely to be protected under the current vaccination policy., (Copyright © 2011 Elsevier Ltd. All rights reserved.)

Background: Although tobacco- and alcohol-associated head and neck cancers are declining in the developed world, potentially human papillomavirus (HPV)-associated oropharnygeal cancers are increasing., Methods: We analysed oropharyngeal and oral cavity cancer rates in Australia in 1982-2005. Cancers from the oropharynx (base of tongue, tonsil and other specific oropharyngeal sites) were classified as potentially HPV associated (n=8844); cancers in other oral cavity and oropharyngeal sites not previously associated with HPV were classified as comparison (n=28,379)., Results: In 2000-2005, an average of 219, 159 and 110 cancers of the tonsil, base of tongue and other oropharyngeal sites were diagnosed annually, with incidences of 1.09 (95% CI: 1.03, 1.15), 0.79 (95% CI: 0.74, 0.84) and 0.55 (95% CI: 0.50, 0.59) per 100,000, respectively. An average of 1242 comparison cancers were diagnosed annually (6.17 (95% CI: 6.03, 6.31) per 100,000). In 1982-2005, there were significant annual increases in tonsil (1.39% (95% CI: 0.88, 1.92%)) and base of tongue cancers in males (3.02% (95% CI: 2.27, 3.78%)) and base of tongue cancer in females (3.45% (95% CI: 2.21, 4.70%)). There was a significant decrease in comparison cancers in men (-1.69% (95% CI: -1.96, -1.42%)), but not in females., Conclusion: Potentially HPV-associated oropharyngeal cancer in Australia is increasing; the impact of HPV vaccination on these cancers should be monitored.

In this review, we describe plans to monitor the impact of human papillomavirus (HPV) vaccine on biologic outcomes in selected international areas (Australia, Canada, Mexico, the Nordic countries, Scotland, and the United States) that have adopted this vaccine. This summary of monitoring plans provides a background for discussing the challenges of vaccine monitoring in settings where resources and capacity may vary. A variety of approaches that depend on existing infrastructure and resources are planned or underway for monitoring HPV vaccine impact. Monitoring HPV vaccine impact on biologic outcomes is a complex and challenging task, but also plays an important role in documenting the benefit of vaccination, monitoring the progress of vaccination programs, and providing data to inform vaccination and disease prevention policies., (Copyright © 2010 Elsevier Ltd. All rights reserved.)