Abstract
BackgroundPrevious analyses from a randomized trial in women aged 24–45 have shown the quadrivalent HPV vaccine to be efficacious in the prevention of infection, cervical intraepithelial neoplasia (CIN) and external genital lesions (EGL) related to HPV 6/11/16/18 through 4 years. In this report we present long term follow-up data on the efficacy, safety and immunogenicity of the quadrivalent HPV vaccine in adult women.Methods Follow-up data are from a study being conducted in 5 sites in Colombia designed to evaluate the long-term immunogenicity, effectiveness, and safety of the qHPV vaccine in women who were vaccinated at 24 to 45 years of age (in the original vaccine group during the base study [n = 684]) or 29 to 50 years of age (in the original placebo group during the base study [n = 651]). This analysis summarizes data collected as of the year 6 post-vaccination visit relative to day 1 of the base study (median follow-up of 6.26 years) from both the original base study and the Colombian follow-up.ResultsThere were no cases of HPV 6/11/16/18-related CIN or EGL during the extended follow-up phase in the per-protocol population. Immunogenicity persists against vaccine-related HPV types, and no evidence of HPV type replacement has been observed. No new serious adverse experiences have been reported.ConclusionsVaccination with qHPV vaccine provides generally safe and effective protection from HPV 6-, 11-, 16-, and 18-related genital warts and cervical dysplasia through 6 years following administration to 24–45 year-old women.Trial Registration Clinicaltrials.gov NCT00090220
Highlights
Persistent infection of the uterine cervix by 15 to 20 carcinogenic human papillomavirus (HPV) genotypes leads to the vast majority of cervical cancers [1,2] and related precursor lesions [3]
The quadrivalent HPV L1 viruslike particle (VLP) vaccine is highly effective in preventing HPV 6, 11, 16, or 18-related high-grade intraepithelial neoplasia and condyloma in men and women aged 16 to 26 naıve to the respective vaccine HPV types at enrollment [9,10] In the pivotal FUTURE II trial (1095) 12,167 women between the ages of 15 and 26 received three doses of either HPV-6/11/16/18 vaccine or placebo, administered at day 1, month 2, and month 6
The efficacy of the quadrivalent HPV (qHPV) vaccine has previously been demonstrated in women 24 to 45 years of age participating in an international double blind clinical trial (FUTURE III) [11]
Summary
Persistent infection of the uterine cervix by 15 to 20 carcinogenic human papillomavirus (HPV) genotypes leads to the vast majority of cervical cancers [1,2] and related precursor lesions [3]. The efficacy of the qHPV vaccine has previously been demonstrated in women 24 to 45 years of age participating in an international double blind clinical trial (FUTURE III) [11]. End of study data (mean followup time of 3.8 years) from FUTURE III demonstrated qHPV vaccine efficacy of 88.7% (95% CI: 78.1, 94.8) against the combined incidence of persistent infection, cervical intraepithelial neoplasia (CIN) or external genital lesions (EGL) related to vaccine HPV types in the per-protocol population on women aged 24–45 [12]. Previous analyses from a randomized trial in women aged 24–45 have shown the quadrivalent HPV vaccine to be efficacious in the prevention of infection, cervical intraepithelial neoplasia (CIN) and external genital lesions (EGL) related to HPV 6/11/16/18 through 4 years. In this report we present long term follow-up data on the efficacy, safety and immunogenicity of the quadrivalent HPV vaccine in adult women
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