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Title: End-of-study safety, immunogenicity, and efficacy of quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine in adult women 24-45 years of age
Authors: X. Castellsagué
N. Mũoz
P. Pitisuttithum
D. Ferris
J. Monsonego
K. Ault
J. Luna
E. Myers
S. Mallary
O. M. Bautista
J. Bryan
S. Vuocolo
R. M. Haupt
A. Saah
Institut d'Investigacio Biomedica de Bellvitge
National Institute of Cancer
Mahidol University
Medical College of Georgia
Department of Cyto-colposcopy
Emory University School of Medicine
Duke University School of Medicine
Merck & Co., Inc.
Keywords: Biochemistry, Genetics and Molecular Biology;Medicine
Issue Date: 28-Jun-2011
Citation: British Journal of Cancer. Vol.105, No.1 (2011), 28-37
Abstract: Background:Previous analyses from a randomised trial in women aged 24-45 years have shown the quadrivalent human papillomavirus (qHPV) vaccine to be efficacious in the prevention of infection, cervical intraepithelial neoplasia (CIN), and external genital lesions (EGLs) related to HPV 6/11/16/18. In this report, we present end-of-study efficacy, safety, and immunogenicity data with a median follow-up time of 4.0 years.Methods:We enrolled 3819 24-45-year-old women with no history of cervical disease or genital warts in the past 5 years. Women received quadrivalent vaccine or placebo at day 1, and at months 2 and 6. Ascertainment of CIN/EGL was accomplished through Pap testing, genital inspection, and cervicovaginal sampling (every 6 months). The main analysis was conducted in a per-protocol efficacy population (that received three doses, was naive to the relevant HPV types at day 1, and remained free of infection through month 7). Efficacy was also estimated in other naive and non-naive populations.Results:Vaccine efficacy against the combined incidence of persistent infection, CIN/EGL related to HPV6/11/16/18 in the per-protocol population was 88.7% (95% CI: 78.1, 94.8). Efficacy for women who were seropositive and DNA negative for the relevant vaccine HPV type at the time of enrolment who received at least 1 dose was 66.9% (95% CI: 4.3, 90.6). At month 48, 91.5, 92.0, 97.4, and 47.9% of vaccinated women were seropositive to HPV 6/11/16/18, respectively. No serious vaccine-related adverse experiences were reported.Conclusions:The qHPV vaccine demonstrated high efficacy, immunogenicity, and acceptable safety in women aged 24-45 years, regardless of previous exposure to HPV vaccine type. © 2011 Cancer Research UK All rights reserved.
ISSN: 15321827
Appears in Collections:Scopus 2011-2015

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