Abstract
BackgroundA large free-of-charge quadrivalent HPV (qHPV) vaccination program, covering four cohorts annually (women 11, 14, 17 and 24 years), has been implemented in Basilicata since 2007. This study evaluated vaccine and non-vaccine HPV prevalence 5-7 years post-vaccination program implementation in vaccinated and unvaccinated women.MethodsThis population-based, cross-sectional study was conducted in the public screening centers of the Local Health Unit in Matera between 2012 and 2014. Cervical samples were obtained for Pap and HPV testing (HC2, LiPA Extra® assay) and participants completed a sociodemographic and behavioral questionnaire. Detailed HPV vaccination status was retrieved from the official HPV vaccine registry. HPV prevalence was described overall, by type and vaccination status. The association between HPV type-detection and risk/protective factors was studied. Direct vaccine protection (qHPV vaccine effectiveness [VE]), cross-protection, and type-replacement were evaluated in cohorts eligible for vaccination, by analyzing HPV prevalence of vaccine and non-vaccine types according to vaccination status.ResultsOverall, 2793 women (18-50 years) were included, 1314 of them having been in birth cohorts eligible for the HPV vaccination program (18- to 30-year-old women at enrolment). Among the latter, qHPV vaccine uptake was 59% (at least one dose), with 94% completing the schedule; standardized qHPV type prevalence was 0.6% in vaccinated versus 5.5% in unvaccinated women (P <0.001); adjusted VE against vaccine type infections was 90% (95% CI: 73%-96%) for all fully vaccinated women and 100% (95% CI not calculable) in women vaccinated before sexual debut. No statistically significant difference in overall high-risk HPV, high-risk non-vaccine HPV, or any single non-vaccine type prevalence was observed between vaccinated and unvaccinated women.ConclusionsThese results, conducted in a post-vaccine era, suggest a high qHPV VE and that a well-implemented catch-up vaccination program may be efficient in reducing vaccine-type infections in a real-world setting. No cross-protective effect or evidence of type-replacement was observed a few years after HPV vaccine introduction.
Highlights
A large free-of-charge quadrivalent human papillomavirus (HPV) vaccination program, covering four cohorts annually, has been implemented in Basilicata since 2007
HPV types that can infect the genital tract can be categorized as high risk (HR) or low risk (LR) according to the degree of risk associated with the development of cervical cancer
polymerase chain reaction (PCR) with specific HPV42 primers was performed on LR-Hybrid Capture® 2 (HC2) positive or borderline samples (HR-HPV HC2 ratio
Summary
A large free-of-charge quadrivalent HPV (qHPV) vaccination program, covering four cohorts annually (women 11, 14, 17 and 24 years), has been implemented in Basilicata since 2007. This study evaluated vaccine and non-vaccine HPV prevalence 5-7 years post-vaccination program implementation in vaccinated and unvaccinated women. Infection with HR-HPV is found in virtually all cases of cervical cancer and is considered a necessary cause of invasive cervical cancer [2]. Among the 12 HPV types considered carcinogenic, HPV16 and HPV18 are the most aggressively oncogenic [3], and are estimated to cause about 70% of invasive cervical cancer cases [4]. In Italy, cervical cancer is the 15th most frequent cancer overall, and the third most frequent among women aged 15-44 years [6]. The overall HPV prevalence for Italy in women with normal cytology has been estimated at 9.7% (95% confidence interval [CI]: 9.4-10) [6]
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