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• Innovax bivalent HPV vaccine (Cecolin), and Gardasil have similar safety profiles. • Two Cecolin doses six months apart are immunologically non-inferior to Gardasil. • Six months after one dose, Cecolin is highly immunogenic. • Cecolin expands the options for HPV vaccination in low- and middle-income countries. World Health Organization human papillomavirus (HPV) vaccination recommendations include a single- or two-dose schedule in individuals 9–20 years old and advice for generating data on single-dose efficacy or immunobridging. The ongoing Phase 3 trial of Innovax's bivalent (types 16 and 18) HPV vaccine (Cecolin®) assesses in low- and middle-income countries alternative dosing schedules and generates data following one dose in girls 9–14 years old. Interim data for the 6-month dosing groups are presented. In Bangladesh and Ghana, 1,025 girls were randomized to receive either two doses of Cecolin at 6-, 12-, or 24-month intervals; one dose of Gardasil® followed by one dose of Cecolin at month 24; or two doses of Gardasil 6 months apart (referent). Serology was measured by enzyme-linked immunosorbent assay (ELISA) and, in a subset, by neutralization assays. Primary objectives include immunological non-inferiority of the Cecolin schedules to referent one month after the second dose. Safety endpoints include reactogenicity and unsolicited adverse events for 7 and 30 days post-vaccination, respectively, as well as serious adverse events throughout the study. Interim analyses included data from the two groups on a 0, 6-month schedule with 205 participants per group. One month after Dose 2, 100% of participants were seropositive by ELISA and had seroconverted for both antigens. Non-inferiority of Cecolin to Gardasil was demonstrated. Six months following one dose, over 96% of participants were seropositive by ELISA for both HPV antigens, with a trend for higher geometric mean concentration following Cecolin administration. Reactogenicity and safety were comparable between both vaccines. Cecolin in a 0, 6-month schedule elicits robust immunogenicity. Non-inferiority to Gardasil was demonstrated one month after a 0, 6-month schedule. Immunogenicity following one dose was comparable to Gardasil up to six months. Both vaccines were safe and well tolerated (ClinicalTrials.gov No. 04508309). [ABSTRACT FROM AUTHOR]

• France has one of the lowest HPV vaccination coverage rates in Europe. • There is no literature concerning school staff's point of view on HPV issues. • No studies have been conducted since the vaccination was recommended for boys in France. • Parents and school staff, including school nurses, experience a lack of knowledge about HPV. • If information is a necessary element to get the capability to get vaccinated, motivation and opportunity are factors cited by parents and school staff. It has been proven that vaccination is effective against Human Papillomavirus (HPV) infections, genital warts, and pre-cancerous and cancerous cervical lesions. Nevertheless, the HPV vaccine coverage of 37.4 % in 2021 in France is one of the lowest in Europe. To explore and understand the reason why French population is so late compared to its neighbours, we carried out focus groups with mothers and with National Education school staff. We aimed to identify knowledge and perceptions of HPV in both study populations, as well as factors influencing HPV vaccination. Between January 2020 and March 2021, we performed a qualitative study using an inductive approach with a thematic content analysis (TCA). We conducted semi-structured focus groups with 29 people including 15 mothers of adolescents in middle schools and 14 school staff from the national education system. Different factors influenced the decision-making process of parents and school staff: knowledge and perceptions of HPV and its vaccine, sources of information about HPV and vaccination. Mothers' discourses differed from those of school staff. They mentioned the importance of gynaecological monitoring and the negative image of pharmaceutical companies, and questioned internet as a reliable source of information. For their part, school staff mentioned cultural and/or religious affiliation, municipalities' role to inform the population, and ethical dilemma or logistical challenges regarding HPV vaccination in schools. The results of these focus groups provided information on which elements may harm or help HPV vaccination. Identified perceptions, beliefs, knowledge, barriers, and facilitators will help us to build an intervention program focus on general practitioners (GP), school staff, parents, and adolescents. [ABSTRACT FROM AUTHOR]

Genital human papillomavirus (HPV) infection is the most prevalent sexually transmitted infection among young adults ages 15–25 years in the United States (US). Although HPV vaccines are recommended for individuals ages through 26 years, vaccine completion rates remain substantially low. Accordingly, our study utilized a comprehensive – Theoretical Domains Framework (TDF) of behavior change to systematically identify facilitators and barriers to catch-up HPV vaccinations. Five databases - Medline, Embase, CINAHL, ERIC, and PsycINFO were searched from January 2009 to July 2019 for empirical studies using quantitative and qualitative methods to assess HPV vaccine uptake among males ages 18–26 years within US college and university settings. The TDF analytic process included a content analysis using the mixed deductive-inductive approach to extract, analyze and categorize data into TDF domains/themes and sub-themes. Overall, 17 studies were selected for data extraction. We identified eleven key TDF domains that influenced HPV vaccination behavior among college male students: 'knowledge' (82% of included studies), 'environmental context and resources' (53%), 'beliefs about consequences' (53%), 'unrealistic optimism' (50%) and 'pessimism' (6%), 'emotion' (50%), 'social influences' (50%), 'beliefs about capabilities' (41%), 'intention' (24%), 'reinforcement' (18%), 'social professional role and identity'(12%), and 'behavioral regulation' (12%). Barriers influencing HPV vaccine uptake included lack of knowledge and awareness regarding HPV infections, HPV vaccine safety, effectiveness, side effects, and costs; absence of health providers' recommendations; lack of healthcare and health insurance; low levels of perceived susceptibility and severity for HPV infections; HPV vaccine misinformation; as well as social stigma and peer influences regarding HPV vaccinations. Enablers for HPV vaccine uptake included high levels of perceived benefits for HPV vaccines. Our study theoretically identified factors influencing HPV vaccinations. This could inform the efficient planning, support, and implementation of interventions that facilitate catch-up HPV vaccination practices among high-risk males within college/university settings. [ABSTRACT FROM AUTHOR]

• Racial/ethnic minorities were less likely to complete the HPV vaccine series. • Patients living in urban regions were more likely to complete the series. • Few HIV-positive Medicaid beneficiaries completed the vaccine series. • Medicaid beneficiaries were more likely to receive the vaccine from physicians. Cancers caused by human papillomavirus (HPV) can be prevented with the timely uptake and completion of the HPV vaccine series. Series completion is associated with increased vaccine effectiveness and longevity of protection. Medicaid beneficiaries are among populations with higher HPV vaccine uptake; however, little research describes factors that influence their HPV vaccine series completion. This study reports on a secondary data analysis of Arizona Medicaid data (Arizona Health Care Cost Containment System) from years 2008–2016. We summarized patient data using descriptive statistics and explored relationships between demographic variables and HPV vaccine administration information using bivariate logistic regression. Results of this analysis showed that females were more likely to complete the series as compared to males, and the age group that had the greatest odd of vaccine completion were 13–17-year-olds, the catch-up vaccine population. White Medicaid beneficiaries were most likely to adhere to HPV vaccine guidelines, followed by Hispanic beneficiaries. Patients receiving care in urban settings were more likely to complete the HPV vaccine series than people receiving care in rural areas of the state. Although statistically insignificant, people living with HIV were less likely to complete the 3-dose series. Future work should focus on ensuring that HPV vaccine age-eligible Medicaid, including people living with HIV, adhere to HPV vaccine guidelines. Expanding programs such as Vaccines for Children and scope of practice for dental professionals to offer the vaccine may provide additional options for Medicaid beneficiaries to vaccinate. [ABSTRACT FROM AUTHOR]

Current human papillomavirus (HPV) vaccine coverage in the United States (in 2019, 66–70%), remains below the Healthy People 2020 coverage goal of 80%. HPV vaccine misinformation, including parental concerns of sexual risk-compensation influence vaccine uptake. We examined the association between HPV vaccination and sexually transmitted infection (STI) outcomes. Of the 20,146 participants from 2013 to 2014 and 2015–2016 cycles of the National Health and Nutrition Examination Survey, 1050 females aged 18–35 with a history of sexual activity had complete case data. Roa-Scott Chi-squared and F-tests assessed survey-weighted socio-demographic differences between vaccinated and unvaccinated participants. Weighted logistic regression assessed crude and adjusted associations between self-reported HPV vaccination (none vs. ≥ 1dose) and lab-confirmed STIs (trichomonas and chlamydia) and vaccine-type HPV (6/11/16/18). As a sensitivity analysis, we conducted weighted-propensity score (PS) models and inverse probability weighting by vaccination status. PS and logistic regression were estimated through survey-weighted logistic regression on variables including race, education, income, marital status, US citizenship, cycle year and age. Overall, 325 (31.8%) females with a history of sexual activity were HPV vaccinated, of which 22 (6.1%) received the vaccine at the routine-recommended ages of 11–12, 65.7% were vaccinated after their self-reported sexual debut, 3.8% had a lab-confirmed STI and 3.5% had vaccine-type HPV. There was no association between HPV vaccination and any STIs (adjusted odds ratio [aOR] 0.67, 95%CI:0.38–1.20), and vaccinated participants had 61% reduced odds of vaccine-type HPV (vs. unvaccinated; aOR 0.39, 95%CI:0.19–0.83). Results from the PS sensitivity analysis were similar to the main findings. Among females who reported a history of sexual activity, HPV vaccination status was protective against vaccine-type HPV and not associated with lab-based STI outcomes. Although findings may be susceptible to reporting bias, results indicating low vaccine uptake at routine-recommended ages requires additional efforts promoting HPV vaccination before sexual-debut. [ABSTRACT FROM AUTHOR]

In the United States, HPV vaccination is routinely recommended at age 11 or 12 years; the series can be started at age 9. We conducted a cohort study to assess long-term immunogenicity of quadrivalent HPV vaccine (4vHPV) in an American Indian/Alaska Native (AI/AN) Indigenous population. During 2011–2014, we enrolled AI/AN girls and boys aged 9–14 years, who were vaccinated with a 3-dose series of 4vHPV. Serum specimens were collected at five time points: immediately prior to doses 2 and 3, and at one month, one year, and two years after series completion. Antibody testing was performed using a multiplex virus-like-particle-IgG ELISA for 4vHPV types (HPV 6/11/16/18). Among 477 children (405 girls/72 boys) completing the 3-dose series, median age at enrollment was 11.2 years. Of the 477, 72 (15%) were tested before dose 2 and 70 (15%) before dose 3. Following series completion, 435 (91%) were tested at one month, 382 (80%) at one year, and 351 (74%) at two years. All tested participants had detectable antibody to 4vHPV types at all time points measured. Geometric mean concentrations (GMCs) for 4vHPV types at one month and two years post-series completion were 269.9 and 32.7 AU/ml for HPV6, 349.3 and 42.9 AU/ml for HPV11, 1240.2 and 168.3 IU/ml HPV16, and 493.2 and 52.2 IU/ml for HPV18. Among children tested after each dose, GMCs after doses 1 and 2 were 3.9 and 32.2 AU/ml for HPV6, 5.3 and 45.6 AU/ml for HPV11, 20.8 and 187.9 IU/ml for HPV16; and 6.6 and 49.7 IU/ml for HPV18. No serious adverse events were reported. All AI/AN children developed antibodies to all 4vHPV types after vaccination. GMCs rose after each dose, then decreased to a plateau over the subsequent two years. This cohort will continue to be followed to determine duration of antibody response. [ABSTRACT FROM AUTHOR]

• Human papillomavirus (HPV) vaccine coverage is very low in France (<30%) • We developed the first questionnaire on HPV vaccine hesitancy determinants in France. • We used the WHO SAGE Vaccine Hesitancy Model of Determinants as a framework. • We conducted a two-round e-Delphi consultation to select the items. • Fifteen experts completed the consultation, leading to the inclusion of 57 items. This study aimed to develop and undertake a preliminary validation of a French Survey Questionnaire for the Determinants of HPV Vaccine Hesitancy (FSQD-HPVH). We undertook an electronic-based Delphi consultation among a panel of Francophone experts in two rounds. Round 1 consisted of the assessment of a structured questionnaire comprising of three parts ((i) Contextual influences, (ii) Individual and group influences, and (iii) Vaccine/vaccination-specific issues), in line with the WHO Strategic Advisory Group of Experts (SAGE) Vaccine Hesitancy (VH) Model of Determinants. Items included in this questionnaire were based on a literature review. Definitions of the factors included in the SAGE model were provided in the questionnaire. The panel of experts was asked to score each item using a 3-point Likert scale, in which 1 meant "Essential", 2 "Useful but not essential", and 3 "Not necessary". The panel was also invited to comment on the clarity/comprehension of the questions and suggest reformulations/additional items. Lawshe's Content Validity Ratio (CVR) was computed to assess the level of consensus for each statement. Only items upon which agreement was not reached in Round 1 (CVR < 0.6) and newly proposed items were submitted for evaluation in Round 2, using the same procedure. Fifteen experts completed the two rounds. Of 83 items evaluated in Round 1, 35 (42%) had a CVR ≥ 0.6 and were accepted without modification. In Round 2, 66 items were submitted to the same panel and consensus was reached for 22 (33%) items using the threshold of 0.6. The final FSQD-HPVH version includes 57 items. This study developed a survey instrument for the evaluation of HPV VH in France with good content validity. It will be used to assess the determinants of HPV VH, the first step towards an evidence-based approach to improving HPV vaccination rates in France. [ABSTRACT FROM AUTHOR]

• There were no decreasing trends in HPV among MSM since girls-only HPV vaccination. • MSM aged 16–24 years tested mostly (sero)negative for the relevant vaccine types. • SHCs could play an important role in promoting HPV vaccination to young MSM. In 2009, girls-only HPV16/18 vaccination was introduced in the Netherlands which has achieved 46–61% uptake. Heterosexual men have benefitted from herd protection, but it is unknown whether men who have sex with men (MSM) also benefit from herd effects of the girls-only HPV16/18 vaccination program. Because MSM bear a high HPV-related disease burden, countries might consider targeted vaccination for MSM. To study possible herd effects and prior HPV exposure at a potential moment of vaccination, we assessed trends in the HPV prevalence and proportions (sero)negative for the various vaccine types among young MSM visiting sexual health centers (SHCs). We used data from MSM included in PASSYON study years 2009–2017. In this biennial cross-sectional study among visitors of SHCs aged 16–24 years, MSM provided a penile and anal swab for HPV DNA testing (including vaccine types HPV6/11/16/18/31/33/45/52/58) and blood for HPV antibody testing (HPV16/18/31/33/45/52/58). In total 575 MSM were included, with a median of 22 years of age and 15 lifetime sex partners and 3.5% HIV positive. Trends in penile or anal HPV prevalence during 2009–2017 were statistically non-significant for all vaccine types. Of the 455 MSM with a penile and anal swab, 360 (79%), 283 (62%) and 242 (53%) were HPV DNA negative at both anatomical sites for HPV16/18, HPV6/11/16/18 and HPV6/11/16/18/31/33/45/52/58 respectively. Among MSM who were HPV16/18 and HPV16/18/31/33/45/52/58 DNA negative and were tested for serology (n = 335 and 279 respectively), 82% and 71% were also seronegative for the respective types. There were no significant declines in the HPV prevalence among MSM up to eight years after introduction of girls-only HPV16/18 vaccination, indicating that MSM are unlikely to benefit largely from herd effects from girls-only vaccination. Most MSM were vaccine-type DNA negative and seronegative, suggesting that vaccination of young MSM visiting SHCs could still be beneficial. [ABSTRACT FROM AUTHOR]

We evaluated racial/ethnic differences in prevalence of oncogenic HPV types targeted by the quadrivalent HPV vaccine (16/18) and nonavalent HPV vaccine (31/33/45/52/58) in women diagnosed with CIN2/3/AIS after quadrivalent HPV vaccine introduction (2008–2015). Typing data from 1810 cervical tissue specimen from HPV-IMPACT (Alameda County, California, US), a population-based CIN2/3/AIS surveillance effort, were analyzed. Using log-binomial regression, we calculated adjusted prevalence ratios (aPR) and 95% confidence intervals (CI) comparing type prevalence by race/ethnicity, adjusted for health insurance, age, CIN2/3/AIS grade, and time period, overall and in the "early vaccine era" (2008–2011) and "later vaccine era" (2012–2015). Overall, oncogenic HPV16/18 prevalence was significantly lower among black (43%) and Hispanic (43%) women compared with white (52%) women (aPR (95% CI): 0.80 (0.70, 0.93) and 0.80 (0.70, 0.91), respectively). In 2008-2011, proportion of HPV16/18 detected was significantly lower in black (47%), Hispanic (46%), and Asian (42%) women compared to white (58%) women (aPR (95% CI): 0.80 (0.67, 0.96), 0.75 (0.63, 0.90), and 0.73 (0.58, 0.90), respectively). There were no significant differences in 2012-2015. Between the two eras, HPV16/18 prevalence declined in white (−11%), black (−9%), and Hispanic (−6%) women, and increased in Asian women (12%). Decreasing HPV 16/18 prevalence in CIN2/3/AIS lesions in white, black, and Hispanic women may suggest benefit from quadrivalent vaccination. In our unadjusted analysis of HPV31/33/45/52/58, prevalence did not differ significantly by race/ethnicity, but was significantly higher among Hispanic women (32%) compared to white women (27%) after adjustment (aPR (95%CI): 1.22 (1.02, 1.47). Prevalence was also non-significantly higher among black (32%) and Asian (33%) women. This analysis suggests that the nonavalent vaccine's potential for impact against cervical precancers will not be lower in women of color compared to white women. These data underscore the importance of equitable vaccination in facilitating continued declines of vaccine-preventable HPV types among all women. [ABSTRACT FROM AUTHOR]

Abstract Background Limited data is available on the use of different HPV vaccines in the same subjects. We evaluated the immunogenicity and safety of a mixed vaccination schedule with one dose of nonavalent (9vHPV) and one dose of bivalent vaccine (2vHPV) administered in different order versus two doses of 9vHPV vaccine. Methods 371 girls and boys aged 9–10 years were randomized (1:1) to receive (I) two doses of 9vHPV or (II) a mixed schedule of 2vHPV + 9vHPV or 9vHPV + 2vHPV with a 6 month interval. Antibodies to HPV were tested by ELISA in blood samples collected one or six months post-first dose and one month post-second dose. Results Post-first dose of 9vHPV 99.4–100% of subjects were seropositive to 9 HPV types included in the vaccine. GMTs varied from 5.0 to 73.6 IU(AU)/ml depending on HPV type. Post-first dose of 2vHPV all subjects were seropositive to HPV16 and 18 (GMTs 16.7 and 11.7 IU/ml, respectively) and 50.0–76.7% were seropositive to 7 types not included in 2vHPV (GMTs varied from 0.3 to 17.5 AU/ml depending on type). Post-second dose all subjects, regardless of the study group, were seropositive to 9 HPV types included in 9vHPV. Anti-HPV16 and 18 GMTs were higher in subjects with the mixed schedule and for the other 7 HPV types higher in subjects who received two doses of 9vHPV vaccine. A higher proportion of subjects who received 2vHPV reported local or systemic adverse events than those who received 9vHPV as the first dose. Post-second dose there were no differences in reported adverse events between the two vaccines. Conclusions The results show the mixed HPV vaccination schedules used in this study are immunogenic and have an acceptable safety profile. Although the seroprotective threshold of antibodies remains unknown the 100% seropositivity to all 9 HPV types included in 9vHPV and the increase of GMTs observed in all study groups post-second dose administration are reassuring and suggest protection might be achieved regardless of the schedule used. Clinical Trials Registration: Clinicaltrials.gov NCT02567955. [ABSTRACT FROM AUTHOR]

Although human papillomavirus (HPV) vaccines were initially licensed based on efficacy after three-dose regimens in women aged 15–26 years, it was recognized early in clinical development that comparable immunogenicity could be obtained after just two doses when administered to younger girls. In both Canada and Mexico, public health authorities made the decision to administer two doses 6 months apart with a planned additional dose at 60 months, while simultaneously doing further study to determine if the third dose would confer meaningful additional benefit. This delayed third dose approach permitted a more cost-effective program with opportunities for improved compliance while minimizing injections and leaving open the opportunity to provide a full three-dose vaccination series. It required close cooperation across many governmental and civil society leadership bodies and real-time access to emerging data on HPV vaccine effectiveness. Although still limited, there is increasing evidence that even one-dose vaccination is sufficient to provide prolonged protection against HPV infection and associated diseases. Ongoing clinical trials and ecological studies are expected to consolidate existing data regarding one dose schedule use. However, to accelerate the preventive effect of HPV vaccination some jurisdictions, in particular those with limited resources may already consider the initiation of a one dose vaccination with the possibility of giving the second dose later in life if judged necessary. Such an approach would facilitate vaccination implementation and might permit larger catch-up vaccination programs in older girls (or as appropriate, girls and boys), thereby accelerating the impact on cervical cancer and other HPV-associated diseases. [ABSTRACT FROM AUTHOR]

Background Cervical cancer occurrence and mortality are strongly correlated with socioeconomic disadvantage, largely due to unequal access to screening and treatment. Universal human papillomavirus (HPV) vaccination provides the opportunity to greatly reduce this global health disparity. Australian Indigenous women have substantially higher rates of cervical cancer than non-Indigenous women, primarily due to under-screening. We investigated HPV infection rates in Indigenous women 7 years after implementation of the national HPV vaccination program. Methods We used a repeat cross-sectional design, with the baseline being provided by an HPV prevalence survey among Indigenous women attending clinics for cervical cytology screening, prior to the start of the vaccination program in 2007. We returned to clinics in four locations during 2014–15, and invited women aged 18–26 years attending for screening to provide a cervical specimen for HPV testing, as well as to complete a short questionnaire and consent to allow access of their records in the National HPV Vaccination Program Register. We used well-established laboratory methods to test specimens for specific HPV genotypes. Results A total of 142 women were recruited at participating sites and compared to 155 who had been recruited at the same locations in the 2007 pre-vaccine survey. The two groups were identical in regard to age, with the more recent group having a higher proportion of hormonal contraception users, and a lower proportion of smokers. The proportion found to have any HPV type fell from 58 to 36% with the decline being entirely due to reductions in vaccine types, which fell by 94% from 24 to 1.4%. Conclusion Australia’s national HPV vaccination program appears to be successfully protecting a very high proportion of Indigenous women against vaccine targeted HPV types, who have in the past been at elevated risk of cervical cancer. [ABSTRACT FROM AUTHOR]

Background Vaccination rates against Human Papillomavirus (HPV) in the US remain alarmingly low. Physicians can significantly influence a parent’s decision to vaccinate their children. However, medical education often lacks training on specific strategies for communicating with vaccine hesitant parents. Methods We created an innovative curriculum designed to teach medical students how to address HPV vaccine hesitancy. The curriculum consisted of (1) a presentation on the epidemiology, biology, and disease morbidity associated with HPV, (2) a video that teaches specific communication strategies and (3) role-playing simulations. This curriculum was delivered to medical students at two separate sites. Medical students were surveyed before and after completing the educational curriculum. The surveys assessed student comfort talking to HPV vaccine hesitant parents and their likelihood to recommend the HPV vaccine. Results Pre- and post-intervention surveys were completed by 101 of the 132 participants (77% response rate). After the intervention, student awareness of the benefits of the HPV vaccine increased by a mean of 0.82 points (Likert scale 1–5, p < 0.01) and student comfort talking to vaccine hesitant parents increased by a mean of 1.37 points (p < 0.01). Prior to the intervention, students more strongly recommended the HPV vaccine to females compared to males, but this gender disparity was eliminated after the intervention (p < 0.01). Personal vaccination status was independately associated with a higher likelihood of recommending the HPV vaccine both before and after the intervention . Conclusion Our innovative curriculum improved medical student comfort level discussing HPV vaccination with hesitant parents and increased the perceived likelihood of recommending HPV vaccination. The intervention is easy to implement, scalable, and requires minimal resources. Educating future providers on this important topic has the potential to improve vaccination rates nationwide and thus should be considered for all medical students. [ABSTRACT FROM AUTHOR]

Therapeutic HPV vaccine is an agent to induce E7-specific Th1 immune responses to treat cervical neoplasia (CIN2-3). Our previous clinical trial has demonstrated that oral administration of HPV16 E7-expressing Lactobacillus casei ( L. casei ), GLBL101c, resulted in the regression of HPV16-related CIN3. Here we examined optimization of the E7-expressing L. casei for induction of the mucosal immune responses to E7. Various doses of HPV16 E7 molecule were displayed on the L. casei . Immunization with E7-bound L. casei showed the induction of E7-specific mucosal IFNγ-producing cells was dependent on displayed E7-doses but saturated beyond 0.3 μg/10 8  cells. A new agent, L. casei with endogenous expression of E7 (IGMKK16E7), showed the optimal amount of displayed-E7. Immunization with IGMKK16E7 demonstrated 4-fold higher induction of E7-specific mucosal IFNγ-producing cells when compared with the former one. Our new system provided the optimal E7-expressing L. casei for displayed-E7 amount and induction of mucosal Th1 immune response. [ABSTRACT FROM AUTHOR]

Background This was an extension study of a randomized, double-blind, placebo-controlled immunogenicity and safety study of the quadrivalent human papillomavirus (qHPV) (HPV 6, 11, 16, and 18) vaccine conducted in Chinese female subjects aged 9–45 years and male subjects aged 9–15 years. To investigate the persistence of anti-HPV 6, -11, -16, and -18 responses among Chinese subjects, subjects enrolled in the base study were followed up at around month 42 (approximately 3.5 years after vaccination). Methods Among 600 subjects enrolled in the base study, a total of 468 subjects consented for participation in the extension study. Anti-HPV 6, -11, -16, and -18 antibodies were detected by the competitive Luminex immunoassay (cLIA) and total IgG Luminex immunoassay (IgG LIA). Results Among the female subjects who received the qHPV vaccine, the proportions of subjects remained seropositive were high with both the cLIA and IgG LIA for HPV type 6, 11, and 16 through approximately 42 months following the first dose vaccination. For HPV 18, the seropositivity rate remained high as 82.0% with the IgG LIA, while it decreased to 53.6% with the cLIA, which was similar to the findings observed in other studies. The seropositivity rates remained high at month 42 for all qHPV types with both the cLIA and IgG LIA among the male subjects. Conclusions Administration of a 3-dose regimen of qHPV vaccine induces durable anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18 responses among Chinese subjects for at least 3.5 years after vaccination. ClinicalTrials.gov registry: NCT01427777 [ABSTRACT FROM AUTHOR]

The development of cervical cancer is mainly caused by infection with high risk genotypes of human papillomavirus, particularly type 16 (HPV16), which accounts for more than 50% of cervical cancer. The two early viral oncogenes, E6 and E7, are continuously expressed in cervical cancer cells and are necessary to maintain the malignant cellular phenotype, thus providing ideal targets for immunotherapy of cervical cancer. In this study, a novel vaccine strategy was developed based on a rationally shuffled HPV16 E6/E7 fusion protein, the addition of Fms-like tyrosine kinase-3 ligand (Flt3L) or the N domain of calreticulin (NCRT), and the usage of a CpG adjuvant. Four recombinant proteins were constructed: m16E6E7 (mutant E6/E7 fusion protein), rm16E6E7 (rearranged mutant HPV16 E6/E7 fusion protein), Flt3L-RM16 (Flt3L fused to rm16E6E7), and NCRT-RM16 (NCRT fused to rm16E6E7). Our results suggest that Flt3L-RM16 was the most potent of these proteins in terms of inducing E6- and E7-specific CD8 + T cell responses. Additionally, Flt3L-RM16 significantly induced regression of established E6/E7-expressing TC-1 tumors. Higher doses of Flt3L-RM16 trended toward higher levels of antitumor activity, but these differences did not reach statistical significance. In summary, this study found that Flt3L-RM16 fusion protein is a promising therapeutic vaccine for immunotherapy of HPV16-associated cervical cancer. [ABSTRACT FROM AUTHOR]

Background Denmark is one of the countries where Human papillomavirus (HPV)-vaccination at present includes only girls. However, the burden of HPV-related cancer in men is increasing, which would argue for gender-neutral vaccination. The aim of this study was to examine the burden of HPV-caused cancers in women and men, and to evaluate the potential of HPV-vaccination in cancer control. Methods Data were retrieved from the literature on population prevalence of high risk (HR) HPV, on HR HPV-prevalence and genotypes in HPV-related cancers, and on number of cytology samples in cervical screening. Data on annual biopsies and conisations were retrieved from the Danish National Health Service Register and the Danish National Patient Register. Incidences of HPV-related cancers in Denmark were extracted from NORDCAN. Number of HPV-caused cancers was calculated from number of HPV-related cancers and the proportion known to be caused by high-risk (HR) HPV. Results In cross-sectional surveys in Denmark, one fifth of women and almost one third of men were found to be positive for HR HPV. Per year, 548 HPV-caused cancer cases were diagnosed in women and 234 in men, and twice as many cancers in women as in men were preventable with HPV vaccination. However, including screening prevented cervical cancers, the burden of cancers caused by HPV-infection would be 1300–2000 in women as compared to 234 in men. Conclusion Taking screening prevented cervical cancers into account, the cancer control potential of HPV-vaccination is considerably higher in women than in men. HPV-vaccination could reduce the burden of screening on women and on health care resources. [ABSTRACT FROM AUTHOR]

We surveyed third-year medical students to assess whether personal vaccination status was associated with willingness to recommend the human papillomavirus vaccine to patients. A total of 231 students completed an anonymous survey evaluating their knowledge, attitudes, and personal vaccine history. Of 122 female students, 81 (66.4%) reported initiating the vaccine, as did 16 of 109 males (14.7%). Females and students ⩽25 years old were more likely to be vaccinated. Knowledge did not vary by vaccination status, but anticipated behaviors did. Vaccinated students reported greater willingness to vaccinate adolescents before 15–16 years of age (92.1% vs. 78.6%, p = 0.008) and discuss vaccination at any type of medical visit (100% vs. 89.7%, p < 0.001). Our findings suggest that prior experiences with the HPV vaccine may influence a provider’s future actions. Thus, interventions that increase awareness of this relationship as well as vaccination rates among health care students may be beneficial. [ABSTRACT FROM AUTHOR]

Background Human papillomavirus (HPV) vaccination programs have been implemented in more than 50 countries. These programs offer tremendous promise of reducing HPV-related disease burden. However, failure to achieve high coverage among high-risk groups may mitigate program success and increase inequalities. We examined sociodemographic inequalities in HPV vaccination coverage in 4 Canadian provinces (Quebec (QC), Ontario (ON), Manitoba (MB), British Columbia (BC)). Methods We obtained annual HPV vaccination coverage of pre-adolescent girls at provincial and regional levels, from the start of programs to 2012/2013. Regions refer to administrative areas responsible for vaccine implementation and monitoring (there are 18/36/10/16 regions in QC/ON/MB/BC). We obtained regions’ sociodemographic characteristics from Statistics Canada Census. We used univariate weighted linear regression to examine the associations between regions’ sociodemographic characteristics and HPV vaccination coverage. Results Provincial HPV vaccination coverage is generally high (QC:78%; ON:80%; MB:64%, BC:69%, 2012/13). QC had the highest provincial vaccination coverage since the program start, but had the greatest inequalities. In QC, regional HPV vaccination coverage was lower in regions with higher proportions of socially deprived individuals, immigrants, and/or native English speakers ( p < 0.0001). These inequalities remained stable over time. Regional-level analysis did not reveal inequalities in ON, MB and BC. Conclusion School-based HPV vaccination programs have resulted in high vaccination coverage in four Canadian provinces. Nonetheless, high overall coverage did not necessarily translate into equality in coverage. Future work is needed to understand underlying causes of inequalities and how this could impact existing inequalities in HPV-related diseases and overall program success. [ABSTRACT FROM AUTHOR]

A recombinant strain of Lactococcus lactis displaying a cell-surface anchored fibronectin binding protein A (FnBPA) from Staphylococcus aureus (LL-FnBPA) had been shown to be more efficient in delivering plasmid than its wild-type counterpart both in vitro and in vivo , and have the ability to orientate the immune response toward a Th2 profile in a context of a DNA vaccination. The aim of this work was to test whether this LL-FnBPA strain could shape the immune response after mucosal administration in mice. For this, we used a mouse model of human papilloma virus (HPV)-induced cancer and a L. lactis strain displaying at its cell surface both HPV-16-E7 antigen (LL-E7) and FnBPA (LL-E7 + FnBPA). Our results revealed a more efficient systemic Th1 immune response with recombinant LL-E7 + FnBPA. Furthermore, mice vaccinated with LL-E7 + FnBPA were better protected when challenged with HPV-16-induced tumors. Altogether, the results suggest that FnBPA displays adjuvant properties when used in the context of mucosal delivery using L. lactis as a live vector. [ABSTRACT FROM AUTHOR]

State immunization and cancer registries contain data that, if linked, could be used to monitor the impact of human papillomavirus (HPV) vaccine on cervical cancer and precancer. Michigan is uniquely positioned to examine these outcomes using two population-based resources: the state-wide cancer registry and immunization information system (IIS). We assessed the feasibility of identifying females in the IIS who had continuous Michigan residence and linking them to the cancer registry. We considered continuous residence necessary for future studies of vaccine impact to avoid misclassifying those who may have been immunized while residing out-of-state and whose immunization therefore may not have been reported in Michigan. We identified females with 1976–1996 birthdates in the IIS and used probabilistic linkage software to match them with Michigan birth records. A stratified random sample of IIS-birth matches was provided to a commercial locator service to identify females with continuous Michigan residence. Cervical carcinoma in situ cases diagnosed in 2006 among females aged 10 through 30 years were also matched with the birth records; cancer registry-birth matches were merged with the IIS-birth matches using the birth record identifier. Overall, 68% of the 1274,282 IIS and 61% of the 1358 cancer registry records could be matched with birth records. Among the sample of IIS-birth matches, most (86%) were continuous residents. Seventy percent or more of cancer registry-birth matches merged with IIS-birth matches for cases born after 1984. This is the first effort in the U.S. to show that linking records across IIS and cancer registries is practical and reasonably efficient. The increasing proportion of matches between the registries and live birth file with birth year, and the use of population-based data, strengthen the utility of this approach. Future steps include use of this method to examine incidence of cervical cancer precursors in HPV immunization-eligible females. [ABSTRACT FROM AUTHOR]

Men who have sex with men (MSM) are at high risk for disease associated with human papillomavirus (HPV). In late 2011, HPV vaccine was recommended for males through age 21 and MSM through age 26. Using data from the 2011 National HIV Behavioral Surveillance System, we assessed self-reported HPV vaccine uptake among MSM, using multivariate analysis to calculate adjusted prevalence ratios (aPRs) and 95% confidence intervals (CIs). Among 3221 MSM aged 18–26, 157 (4.9%) reported ≥1 vaccine dose. Uptake was higher among men who visited a healthcare provider (aPR 2.3, CI: 1.2–4.2), disclosed same-sex sexual attraction/behavior to a provider (aPR 2.1, CI: 1.3–3.3), reported a positive HIV test (aPR 2.2, CI: 1.5–3.2), or received hepatitis vaccine (aPR 3.9, CI: 2.4–6.4). Of 3064 unvaccinated MSM, 2326 (75.9%) had visited a healthcare provider within 1 year. These national data on HPV vaccine uptake among MSM provide a baseline as vaccination recommendations are implemented. [ABSTRACT FROM AUTHOR]

Background Recent evidence suggests that two doses of HPV vaccines may be as protective as three doses in the short-term. We estimated the incremental cost-effectiveness of two- and three-dose schedules of girls-only and girls & boys HPV vaccination programmes in Canada. Methods We used HPV-ADVISE, an individual-based transmission-dynamic model of multi-type HPV infection and diseases (anogenital warts, and cancers of the cervix, vulva, vagina, anus, penis and oropharynx). We conducted the analysis from the health payer perspective, with a 70-year time horizon and 3% discount rate, and performed extensive sensitivity analyses, including duration of vaccine protection and vaccine cost. Findings Assuming 80% coverage and a vaccine cost per dose of $85, two-dose girls-only vaccination (vs. no vaccination) produced cost/quality-adjusted life-year (QALY)-gained varying between $7900–24,300. The incremental cost-effectiveness ratio of giving the third dose to girls (vs. two doses) was below $40,000/QALY-gained when: (i) three doses provide longer protection than two doses and (ii) two-dose protection was shorter than 30 years. Vaccinating boys (with two or three doses) was not cost-effective (vs. girls-only vaccination) under most scenarios investigated. Interpretation Two-dose HPV vaccination is likely to be cost-effective if its duration of protection is at least 10 years. A third dose of HPV vaccine is unlikely to be cost-effective if two-dose duration of protection is longer than 30 years. Finally, two-dose girls & boys HPV vaccination is unlikely to be cost-effective unless the cost per dose for boys is substantially lower than the cost for girls. [ABSTRACT FROM AUTHOR]

Highlights: [•] Mixed HPV infections are not uncommon in cervical biopsies. [•] A single HPV genotype is associated with an independent cervical lesion. [•] LCM is an ideal method to attribute HPV genotype to specific cervical lesions. [•] LCM will improve assessment of vaccine. [Copyright &y& Elsevier]

Highlights: [•] We evaluated the immunogenicity and safety of 2 tetravalent HPV vaccines. [•] Immune responses were compared to the licensed bivalent HPV-16/18 L1 VLP vaccine. [•] HPV-16 and -18 antibody titers were lower when additional HPV L1 VLPs were added. [•] Immune interference was not always overcome by changing the VLP dose or adjuvant. [•] All vaccine formulations had an acceptable reactogenicity and safety profile. [ABSTRACT FROM AUTHOR]

Highlights: [•] Two-dose HPV schedules are as efficacious as three-dose schedules in the short term. [•] The benefit of the third dose depends on duration of two-dose vaccine protection. [•] If two doses protect for at least 20 years, the benefit of the third dose is small. [Copyright &y& Elsevier]

Highlights: [•] Use of adolescent and community views may lead to greater support for the SBIP. [•] Community and adolescent views on the SBIP provided unique insights for improvement. [•] Citizens juries offer a unique and rigorous methodology for accessing community and adolescent views to impact policy and practice. [ABSTRACT FROM AUTHOR]

Highlights: [•] Delayed initiation of HPV vaccination beyond the recommended 11–12 years was common. [•] Many patients had evidence of sexual experience before their first HPV vaccine dose. [•] Many patients had abnormal cervical cytology before their first HPV vaccine dose. [•] Missed opportunities for timely HPV vaccination occurred frequently. [•] Strategies to reduce missed opportunities for timely HPV vaccination are needed. [Copyright &y& Elsevier]

Abstract: Background: The Human papillomavirus (HPV) vaccine has been available for protection against HPV-associated cervical cancer and genital warts since 2006. Nonetheless, uptake has varied among countries and populations within countries. Studies have found that individuals’ knowledge and attitudes toward the vaccine are associated with immunization uptake. The purpose of the current review is to summarize and evaluate the evidence for educational interventions to increase HPV vaccination acceptance. Methods: We searched the databases of PubMed and Web of Science for English-language articles describing educational interventions designed to improve HPV vaccination uptake, intention or attitude. Results: We identified 33 studies of HPV vaccination educational interventions: 7 tested the effectiveness of interventions with parents, 8 with adolescents or young adults, and 18 compared the effectiveness of different message frames in an educational intervention among adolescents, young adults or their parents. Most studies involved populations with higher educational attainment and most interventions required participants to be literate. The minority of studies used the outcome of HPV vaccine uptake. Well-designed studies adequately powered to detect change in vaccine uptake were rare and generally did not demonstrate effectiveness of the tested intervention. Conclusions: There is not strong evidence to recommend any specific educational intervention for wide-spread implementation. Future studies are required to determine the effectiveness of culturally-competent interventions reaching diverse populations. [Copyright &y& Elsevier]

Highlights: [•] We describe the frequency of HPV infection and HPV types in HIV-infected women in India. [•] More than two-fifths of HIV-infected women had high-risk of HPV infection. [•] Three-fourths of HIV infected women with cervical neoplasia had high-risk of HPV infection. [•] HPV 16 was the most common type followed by HPV 31 and HPV 56. [•] A very high frequency of high-risk HPV and multiple infections in HIV-infected women. [Copyright &y& Elsevier]

Highlights: [•] Cervarix® demonstrated, in clinical trials, an overall 93.2% efficacy against CIN3+. [•] This efficacy translates into a large number of lives saved in all countries; an additional 18–34% more lives saved than expected based on protection against HPV-16/18 only. [•] Public health benefit also includes reduction in costs, morbidity and suffering. [ABSTRACT FROM AUTHOR]

Highlights: [•] 2836 eligible women contacted (2.9% of numbers dialed) and 80.0% participated. [•] HPV vaccine coverage for HPV vaccine program age eligible adult women was 64/59/53% for dose 1/2/3. [•] Coverage was 9/14/21% higher than Register estimates after the catch up program. [•] In a validation substudy, 86% of self reported HPV vaccine doses were validated. [ABSTRACT FROM AUTHOR]

Highlights: [•] Providers underestimated the importance of vaccines to parents and overestimated parental concern regarding number of injections. [•] Among parents expressing a preference, injections were preferred to oral or intranasal routes. [•] Parents rated disease prevention higher than injection number in vaccine decisions. [ABSTRACT FROM AUTHOR]

Abstract: Background: Females who receive the human papillomavirus (HPV) vaccine may believe they are protected from developing cervical cancer and no longer require screening. Concern has also been expressed that vaccinated females are those that would be screened regularly. This study assesses the Pap testing behavior of vaccinated and non-vaccinated females. Methods: For this population-based retrospective cohort study, vaccination and screening registries were linked for 3540 vaccinated females aged 15 years and over and 9592 matched non-vaccinated females. Conditional logistic regression, the Kaplan–Meier method and Cox regression were used to examine the association between vaccination and Pap testing. Results: Vaccinated females were more likely to have had a Pap test within the year prior to the index date than non-vaccinated females (15–19 years old: OR=1.38, 95% CI 1.20–1.59; 20+ years old: OR=2.34, 95% CI 1.98–2.76). In the three-year period after the index date, vaccinated females had a significantly higher cumulative probability of having a Pap test (83.3%) than non-vaccinated females (66.1%). Females who had a Pap test within three years prior to the index date were more likely to have a Pap test after the index date (vaccinated: HR=5.03, 95% CI 4.65–5.45; non-vaccinated HR=3.97, 95% CI 3.70–4.24). Being vaccinated had a significant effect on Pap testing (15–19 years old: HR=1.54, 95% CI 1.39–1.69; 20+ years old: HR=1.87, 95% CI 1.52–2.31). 80.1% of vaccinated females who had a Pap test prior to the index date also had one subsequent to it, compared to 70.1% for non-vaccinated females. 41.1% of females had not been vaccinated nor had a Pap test. Conclusion: The majority of vaccinated females continue to participate in screening, and do so at a higher rate than non-vaccinated females. Renewed efforts need to be made to include the large proportion of non–vaccinated, non–screened females in vaccination and/or screening. [Copyright &y& Elsevier]

Highlights: [•] We monitor HPV infection in sexually active young women in England. [•] The prevalence of HPV 16/18 has reduced within 3 years of HPV immunisation. [•] Reductions in HPV 16/18 were greatest at ages with highest immunisation coverage. [•] The data suggest reductions in HPV 16/18 amongst unvaccinated young women and men. [ABSTRACT FROM AUTHOR]

Highlights: [•] The vaccine antigens are 4 human papillomavirus type 16 E6 peptides. [•] Candida skin test reagent is the vaccine adjuvant. [•] The partial Langerhans cell maturation effects are due to the peptides. [•] Candida has the T-cell proliferative effect. [•] IL-12 is the most commonly expressed cytokine by the Langerhans cells. [Copyright &y& Elsevier]

Highlights: [•] HPV-16/18 vaccine had acceptable safety and reactogenicity in HIV-positive women. [•] All HIV-positive women were seropositive for HPV-16 and HPV-18 after vaccination. [•] Antibody levels after vaccination were higher than after natural infection with HPV. [•] Vaccination induced sustained anti-HPV-16/18 CD4+ T-cell responses. [•] No association seen between immune response and CD4+ T-cell count or HIV viral load. [ABSTRACT FROM AUTHOR]

Highlights: [•] Brief description of HPV-associated oropharyngeal cancer disparities. [•] Highlights current evidence which suggest that existing HPV vaccines may well prevent HPV-associated oropharyngeal cancer. [•] Discusses value of mandating HPV vaccine as a school entry law. [•] An analogy with smallpox vaccine as a lesson in compulsory vaccination. [•] Highlights possible unintended consequences of implementing recommended policy. [ABSTRACT FROM AUTHOR]

Highlights: [•] Clinicians and parents were preferred sources of HPV vaccine information for girls. [•] Vaccine efficacy and risks/benefits were the most commonly reported discussion topics. [•] Girls may be missing important vaccine-related messages about sexual health topics. [•] Clinicians should ensure that girls actively engage in HPV vaccination discussions. [•] Educating parents may help reduce vaccine-related misperceptions among girls. [ABSTRACT FROM AUTHOR]

Highlights: [•] We modelled the cost-effectiveness of HPV vaccination in adult women in Belgium. [•] Vaccination with the HPV-16/18 vaccine was cost-effective to at least age 40 years. [•] Cross-protection increased the cost-effectiveness of HPV vaccination. [•] Extending HPV vaccination to adult women would reduce the burden of cervical cancer. [ABSTRACT FROM AUTHOR]

Highlights: [•] We reviewed economic analyses of HPV vaccination in low/middle income countries. [ • ] Vaccines may be cost-effective, particularly when there are no organized screening programmes. [ • ] Uncertainty could be reduced by clarity about vaccine prices and delivery costs. [ABSTRACT FROM AUTHOR]

Abstract: This study investigates the effect of communication strategies on human papillomavirus (HPV) vaccine uptake in HPV vaccine demonstration projects in Uganda and Vietnam. Secondary analysis was conducted on data from surveys of a representative sample of parents and guardians of girls eligible for HPV vaccine, measuring three-dose coverage achieved in demonstration projects in 2008–2010. Univariate and multivariate logistic regression analysis calculated the unadjusted and adjusted odds of receiving at least one dose of HPV vaccine depending on exposure to community influencers; information, education, and communication (IEC) channels; and demographic factors. This study found that exposure to community influencers was associated with HPV vaccine uptake in a multivariate model controlling for other factors. Exposure to non-interactive IEC channels was only marginally associated with HPV vaccine uptake. These results underscore the need of HPV vaccine programs in low- and middle-income countries to involve and utilize key community influencers and stakeholders to maximize HPV vaccine uptake. [Copyright &y& Elsevier]

Highlights: [•] Predicting CTL epitopes based on distribution of HLA was a potential strategy for therapeutic vaccine design. [•] Combination of four predicted epitopes of HPV-16 E6 and E7 could vaccinate >50% of all individuals worldwide. [•] We report likely candidate CTL epitopes or their combination for therapeutic vaccine of cervical cancer. [•] The use of recyclable markers enables high-yield secretion of multiple proteins from a single host. [Copyright &y& Elsevier]

Abstract: Background: Differences in sexual behaviour are partly responsible for significant inequalities in human papillomavirus (HPV)-related diseases between sub-populations. Our aim was to illustrate how differential HPV vaccine uptake by sexual behaviour can impact population-level vaccination effectiveness and inequalities in HPV prevalence. Methods: We used a multi-type individual-based transmission-dynamic model of HPV infection. The modelled population is stratified into 4 sexual activity levels (low=L0, high=L3). The model was calibrated to Canadian epidemiological data, including the proportion of sexually active individuals by gender and type-specific HPV prevalence by level of sexual activity. Vaccine uptake by sexual activity level was varied in one-way sensitivity analyses. Uncertainty in model predictions is presented using the median [10-90th percentiles] of simulations. Results: In our pre-vaccination calibrated modelled population, the most sexually active risk groups (L2–L3) account for 43% of prevalent HPV-16/18 infections while only representing 20% of the population. Under base case assumptions (age at vaccination=12 years, vaccine efficacy=100%, average duration of protection=20 years, overall coverage=50%), vaccinating girls is predicted to reduce HPV-16/18 prevalence by 56% [46–69] at equilibrium (70 years post-vaccination) when uptake is uniform across sexual activity levels, and by 35% [28–40] when uptake is maldistributed (L0: 100%, L1: 55%, L2: 0%, L3: 0%). At uniform 50% vaccination coverage across risk groups, HPV-16/18 prevalence is predicted to be reduced by 62% [52–73], 74% [57–82], 40% [24–60], and 28% [7–54] at equilibrium among women in levels of sexual activity L0, L1, L2 and L3, respectively. Conclusions: A low vaccine uptake in girls at highest risk of future HPV acquisition may substantially limit population effectiveness of vaccination. Vaccination effectiveness is lower in more sexually active groups due to smaller herd effects. Uniform vaccination coverage across sub-populations may not be able to decrease existing inequalities in HPV infection and disease unless coverage is high enough to produce herd effects in higher risk groups. [Copyright &y& Elsevier]

Abstract: Background: Vaccination against human papillomavirus (HPV) types 16 and 18 is recommended for girls aged 11 or 12 years with catch-up vaccination through age 26 in the U.S. Cervical intraepithelial neoplasia (CIN) grade 2 or 3 and adenocarcinoma in situ (CIN2+) are used to monitor HPV vaccine impact on cervical disease. This report describes vaccination status in women diagnosed with CIN2+ and examines HPV vaccine impact on HPV 16/18-related CIN2+. Methods: As part of a vaccine impact monitoring project (HPV-IMPACT), females 18–31 years with CIN2+ were reported from pathology laboratories in CA, CT, NY, OR, TN from 2008 to 2011. One diagnostic block was selected for HPV DNA typing with Roche Linear Array. Demographic, abnormal Papanicolaou (Pap) test dates and vaccine status information were collected. The abnormal Pap test immediately preceding the CIN2+ diagnosis was defined as the ‘trigger Pap’. Results: Among 5083 CIN2+ cases reported to date, 3855 had vaccination history investigated; 1900 had vaccine history documented (vaccinated, with trigger Pap dates, or unvaccinated). Among women who initiated vaccination >24 months before their trigger Pap, there was a significantly lower proportion of CIN2+ lesions due to 16/18 compared to women who were not vaccinated (aPR=.67, 95% CI: .48–.94). Among the 1900 with known vaccination status, 20% initiated vaccination on/after their trigger screening. Women aged 21–23 years were more likely to initiate vaccination on/after the trigger Pap compared to 24–26 year olds (29.0% vs. 19.6%, p =.001), as were non-Hispanic blacks compared to non-Hispanic whites (27.3% vs. 19.0%, p =.001) and publicly compared to privately insured women (38.1% vs. 17.4%, p <.0001). Conclusion: We found a significant reduction in HPV 16/18-related lesions in women with CIN2+ who initiated vaccination at least 24 months prior to their trigger Pap. These preliminary results suggest early impact of the HPV vaccine on vaccine-type disease, but further evaluation is warranted. [Copyright &y& Elsevier]

Abstract: The alarming national data on the mortality and morbidity rates of cervical cancer as well as the results of a Hungarian survey demonstrating adolescents’ low level of understanding of human papillomavirus (HPV) infection and HPV vaccination encouraged the authors to conduct an educational intervention. The aim of this survey was to explore the impact of a brief, HPV-focused program on adolescents’ knowledge, beliefs and attitudes. A self-administered anonymous questionnaire was completed by 394 male and female adolescents in September, 2010, in Hungary. Half of the students (48.5%) then had a one-off educational intervention on aspects cervical cancer lasting 45min lesson, while the rest of the participants, the control group, did not have the educational intervention. Three months following the education, both groups were retested using the same questionnaire. Data were analysed using Statistical Package for the Social Sciences (SPSS). Following the education, significant increase was detected in cervical cancer awareness: causal relationship between HPV and cervical cancer (7.9%→22.1%, p <0.05), or perception of HPV vaccination (61.3%→85.9%, p <0.05). Similarly, health-related beliefs have enhanced, such as ‘HPV may cause cervical cancer’ (64.9%→81.0%, p <0.05) or ‘cervical cancer may be prevented by vaccination’ (66.5%→85.3%, p <0.05). Our data also highlighted that Hungarian adolescents have been practising extremely risky sexual behaviour. Nearly half of the sexually active adolescents had engaged in ‘one-night relationship’ (41.1%) as well as having sexual intercourse without any contraceptive safety measures (44.3%). In addition to providing adolescents with clear and meaningful information about the implications of a HPV infection and addressing their fears of screening and vaccination, health education should focus on promoting safe sex behaviour by promoting the use of condoms and reducing the number of sexual partners to limit the spread of HPV, and also on encouraging the participation in regular cervical screenings, thus reducing the incidence of cervical cancer. [Copyright &y& Elsevier]

Abstract: Objective: To evaluate a brief intervention to increase provision of adolescent vaccines at health centers that reach the medically underserved. Method: In April 2010, clinical coordinators from 17 federally qualified health centers (serving 7827 patients ages 12–17) participated in a competition to increase uptake of recommended adolescent vaccines: tetanus, diphtheria, and pertussis booster; meningococcal conjugate; and human papillomavirus. Vaccination coordinators attended a webinar that reviewed provider-based changes recommended by the CDC''s Assessment, Feedback, Incentives, and eXchanges (AFIX) program and received weekly follow-up emails. Data on vaccine uptake came from the North Carolina Immunization Registry. Results: Uptake of targeted adolescent vaccines increased during the one-month intervention period by about 1–2% (all p <.05). These small but reliable increases were greater than those observed for non-targeted vaccines (measles, mumps, and rubella; hepatitis B; and varicella). Conclusion: This AFIX webinar led to small increases in provision of targeted adolescent vaccines over a one-month period. Similar, sustainable programs at healthcare facilities, including federally qualified health centers that function as safety net providers for medically underserved populations could help reach populations with great need. [Copyright &y& Elsevier]

Abstract: Australia implemented a National HPV Vaccination Program in 2007, with routine vaccination of 12–13 year old females and catch-up in females aged 13–26years to 2009. The aim of this study was to estimate the impact of the current female-only national vaccination program on males, and then to estimate the incremental benefits to males from being included in the program. We used preliminary data to estimate vaccination coverage in females. We then fitted a dynamic model of sexual behaviour and HPV transmission in Australia to local data on female pre-vaccination age-specific HPV prevalence, predicted the corresponding pre-vaccination prevalence in males due to heterosexual transmission, and modelled the short and long term impact of female-only versus female-and-male vaccination programs. The estimated 3-dose female coverage rates were 78% (range 70–80%) for ongoing coverage in 12–13 year old girls; and from 74% (range 70–80%) in 14 year olds, to 25% (range 15–35%) for women aged 26years old in 2007. The median estimate for age-standardised pre-vaccination HPV 16 prevalence in females and males aged 15–59years was 3.2% (95% range: 2.4–4.1%) and 3.1% (95% range: 2.2–4.2%), respectively. The current program in females is predicted to result in a 68% reduction in male HPV 16 infections by 2050, leading to an estimated long term reduction of 14% in rates of cancers of the head, neck and anogenital area. The estimated proportion of the maximum possible vaccine-conferred benefit to males from a female-and-male program which will be achieved by female-only vaccination is 73% (range in probabilistic sensitivity analysis: 53–78%). In conclusion, up to three-quarters of the maximum possible vaccination-conferred benefit to males due to reduced heterosexual transmission will be achieved by the existing female-only program. [Copyright &y& Elsevier]

Abstract: Hungary takes the fourth place regarding the incidence and the fifth regarding the mortality of cervical cancer among the member countries of the European Union, with 500 deaths due to this preventable illness and nearly 1200 new cases diagnosed every year. Although the vaccines have been available for 3 years, the estimated rate of the female population vaccinated against HPV is approximately 10% in the 12–26-year-age cohort. The aim of this study was to determine factors and motivations affecting the uptake of HPV vaccination among Hungarian adolescents. Examining the effects of some possible sociodemographic predictors (age and gender) and the exposure to health information on HPV vaccine acceptability were also focused on, as well as assessing the most trusted sources of information about sexually transmitted diseases (STDs). A nationwide anonymous questionnaire survey with a sample of 1769 students attending public primary or secondary schools was organised by the authors in 16 Hungarian cities and towns. Data were analysed using the Statistical Package for the Social Sciences (SPSS). Adolescents’ awareness of HPV was relatively low. Only 35% of the participants reported they had heard about HPV prior to the survey. Almost 70% of the potentially affected study population had not heard about the vaccine previously. Every fourth student did not believe that vaccination against HPV can prevent cervical cancer. If the vaccination was available free of charge, almost 80% of respondents would request it, but in case they had to pay for it, this number would significantly decrease. Significantly better knowledge and also more positive attitudes towards HPV vaccination was found in relation to the number of information sources. The majority of respondents (62–83%) were open for further information about STDs. The main trusted mediators were school-health services (61.3%), education on health at school (49.2%), health professionals (42.2%) and electronic media (24.6%). Since Hungarian adolescent students expect guidance about STDs principally from school health education, an urgent need for well-designed, HPV-focused educational programmes emerges. Launching such programmes would be especially important for the adolescent population to increase their awareness of the risks associated with HPV infection thus reducing the high incidence of cervical cancer in Hungary in the future. [Copyright &y& Elsevier]

Abstract: Background: If women who receive the human papillomavirus (HPV) vaccine are unduly reassured about the cancer prevention benefits of vaccination, they may choose not to participate in screening, thereby increasing their risk for cervical cancer. This study assesses adult women''s knowledge of the need to continue cervical cancer screening after HPV vaccination, describes Pap test intentions of vaccinated young adult women, and evaluates whether knowledge and intentions differ across groups at greatest risk for cervical cancer. Methods: Data were from the 2008 Health Information National Trends Survey (HINTS) and the 2008 National Health Interview Survey (NHIS), which initiated data collection approximately 18 months after the first FDA approval of an HPV vaccine. We calculated associations between independent variables and the outcomes using chi-square tests. Results: Of 1586 female HINTS respondents ages 18 through 74, 95.6% knew that HPV-vaccinated women should continue to receive Pap tests. This knowledge did not vary significantly by race/ethnicity, education, income, or healthcare access. Among 1101 female NHIS respondents ages 18–26 who had ever received a Pap test, the proportion (12.7%; n =139) who reported receipt of the HPV vaccine were more likely than those not vaccinated to plan to receive a Pap test within three years (98.1% vs. 92.5%, p <0.001). Conclusions: US adult women possess high knowledge and intention to participate in Pap testing after HPV vaccination. The vast majority of young adult women who received the HPV vaccine within its first two years on the market intend to participate in cervical cancer screening in the near future. Future studies are needed to examine whether those vaccinated in adolescence will become aware of, and adhere to, screening guidelines as they become eligible. [Copyright &y& Elsevier]