High HPV vaccine uptake in a single-cohort program aimed at largely HPV-naive girls reduced vaccine types by 90% in vaccinated and 54% in unvaccinated girls. Indication of cross-protection in both vaccinated and unvaccinated girls was also observed.
BackgroundHuman papillomavirus (HPV) testing as primary screening for cervical cancer is currently being implemented in Norway in a randomized controlled fashion, involving three laboratories. As part of the quality assurance programme of the implementation, an evaluation of the inter-laboratory reproducibility of the HPV test was initiated, to ensure satisfactory HPV test reliability in all three laboratories.MethodsThe HPV test used is the cobas 4800 HPV Test, detecting 14 high-risk types with individual HPV genotype results for HPV16 and HPV18. In addition to the three laboratories involved in the implementation, the Norwegian HPV reference laboratory was included as a fourth comparative laboratory. A stratified sample of 500 cervical liquid based cytology (LBC) samples was used in the evaluation, with an aim towards a high-risk HPV positivity of ~25%. Samples were collected at one laboratory, anonymized, aliquoted, and distributed to the other laboratories.ResultsComparison of the test results of all four laboratories revealed a 95.6% agreement, an 86.3% positive agreement and a kappa value of 0.94 (95% CI 0.92–0.97). For negative cytology specimens, there was a 95.8% overall agreement, a 67.4% positive agreement, and a kappa value of 0.88 (95% CI 0.80–0.93). For abnormal cytology specimens, there was a 95.8% overall agreement, a 95.5% positive agreement, and a kappa value of 0.86 (95% CI 0.71–0.97).ConclusionsThe study showed a high inter-laboratory reproducibility of HPV testing, implying satisfactory user performance and reliability in the laboratories involved in the implementation project. This is important knowledge and we recommend similar studies always to be performed prior to the introduction of new screening routines.Electronic supplementary materialThe online version of this article (doi:10.1186/s12879-016-2028-7) contains supplementary material, which is available to authorized users.
BackgroundThe aim of the current study was to assess the HPV prevalence in unscreened and unvaccinated young women living in Norway, to provide important baseline data for early estimation of the impact of the HPV vaccination program.MethodsA total of 13,129 self-sampled urine samples from two complete birth-cohorts of 17-year old women born in 1994 and 1996 and one third of a birth-cohort of 21-year old women born in 1990, were analysed for the presence of 37 HPV types using PCR and a DNA hybridization technique.ResultsIn the two birth cohorts of 17-year old women, HPV was detected in 19.9% (95% CI 18.8–20.9) and 15.4% (95% CI 14.5–16.3), respectively. High-risk HPV types were detected in 11.2% (95% CI 10.3–12.0) and 7.6% (95% CI 6.9–8.2), respectively, while vaccine types were detected in 7.4% (95% CI 6.7–8.1) and 6.0% (95% CI 5.4–6.6), respectively. Among the 21-year old women HPV was detected in 45.4% (95% CI 42.9–47.8), whereas high-risk types were detected in 29.8% (95% CI 27.5–32.0). Vaccine types (HPV 6, 11, 16, 18) were detected in 16.2% (95% CI 14.4–18.1).ConclusionThis large population based study confirms that HPV testing in urine samples is easy and highly feasible for epidemiological studies and vaccine surveillance in young women. HPV was very common and a broad spectrum of HPV types was identified. Differences in HPV prevalence was seen both between age groups and between the two birth cohorts of 17-year old women.
BackgroundMany countries have initiated school-based human papillomavirus (HPV) vaccination programs. The real-life effectiveness of HPV vaccines has become increasingly evident, especially among girls vaccinated before HPV exposure in countries with high vaccine uptake. In 2009, Norway initiated a school-based HPV vaccination program for 12-year-old girls using the quadrivalent HPV vaccine (Gardasil®), which targets HPV6, 11, 16, and 18. Here, we aim to assess type-specific vaginal and oral HPV prevalence in vaccinated compared with unvaccinated girls in the first birth cohort eligible for school-based vaccination (born in 1997).MethodsThis observational, cross-sectional study measured the HPV prevalence ratio (PR) between vaccinated and unvaccinated girls in Norway. Facebook advertisement was used to recruit participants and disseminate information about the study. Participants self-sampled vaginal and oral specimens using an Evalyn® Brush and a FLOQSwab™, respectively. Sexual behavior was ascertained through a short questionnaire.ResultsAmong the 312 participants, 239 (76.6%) had received at least one dose of HPV vaccine prior to sexual debut. 39.1% of vaginal samples were positive for any HPV type, with similar prevalence among vaccinated and unvaccinated girls (38.5% vs 41.1%, PR: 0.93, 95% confidence interval [CI]: 0.62–1.41). For vaccine-targeted types there was some evidence of lower prevalence in the vaccinated (0.4%) compared to the unvaccinated (6.8%) group (PR: 0.06, 95%CI: 0.01–0.52). This difference remained after adjusting for sexual behavior (PR: 0.04, 95%CI: 0.00–0.42). Only four oral samples were positive for any HPV type, and all of these participants had received at least one dose of HPV vaccine at least 1 year before oral sexual debut.ConclusionThere is evidence of a lower prevalence of vaccine-targeted HPV types in the vagina of vaccinated girls from the first birth cohort eligible for school-based HPV vaccination in Norway; this was not the case when considering all HPV types or types not included in the quadrivalent HPV vaccine.
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