Journal article
Overall efficacy of HPV-16/18 AS04-adjuvanted vaccine against grade 3 or greater cervical intraepithelial neoplasia: 4-year end-of-study analysis of the randomised, double-blind PATRICIA trial
M Lehtinen, J Paavonen, CM Wheeler, U Jaisamrarn, SM Garland, X Castellsagué, SR Skinner, D Apter, P Naud, J Salmerón, SN Chow, H Kitchener, JC Teixeira, J Hedrick, G Limson, A Szarewski, B Romanowski, FY Aoki, TF Schwarz, WAJ Poppe Show all
Lancet Oncology | ELSEVIER SCIENCE INC | Published : 2012
Abstract
Background: Cervical intraepithelial neoplasia grade 2 or greater (CIN2+) is the surrogate endpoint used in licensure trials of human papillomavirus (HPV) vaccines. Vaccine efficacy against CIN3+, the immediate precursor to invasive cervical cancer, is more difficult to measure because of its lower incidence, but provides the most stringent evidence of potential cancer prevention. We report vaccine efficacy against CIN3+ and adenocarcinoma in situ (AIS) in the end-of-study analysis of PATRICIA (PApilloma TRIal against Cancer In young Adults). Methods: Healthy women aged 15-25 years with no more than six lifetime sexual partners were included in PATRICIA, irrespective of their baseline HPV DN..
View full abstractGrants
Funding Acknowledgements
DD, GD, FS, and M-PD are employees of GlaxoSmithKline Biologicals. DD, GD, and FS own stock in GlaxoSmithKline Biologicals, and GD holds a relevant patent. All investigators at study clinical sites were funded through their institutions to do the study protocol. CMW, DA, JP, PN, HK, PDS, FYA, FXB, JH, SRS, SMG, ML, TFS, AS, XC, JCT, and BR have received funding through their institutions to do HPV vaccine studies for GlaxoSmithKline Biologicals or Merck Sharp & Dohme (Sanofi Pasteur MSD). JP received a research grant through the Helsinki University Hospital Research Institute to conduct clinical trials on HPV vaccination. SRS has also received funding through her institution from CSL to do research on school-based adolescent HPV vaccination. Through the University of New Mexico, CMW has received equipment and reagents for HPV genotyping from Roche Molecular Systems and funding for HPV vaccine studies from GlaxoSmithKline (in addition to the present study) and Merck & Co. FXB is an editor of the international newsletter (HPV TODAY) and guest editor of the journal Vaccine to prepare international reviews on topics related to HPV. WAJP, NSDC, FXB, XC, SMG, PN, BR, TFS, and AS have received consulting fees. SMG, SRS, FYA, PN, and TFS have received honoraria; TFS, BR, and FXB have been paid for expert testimony; BR, FYA, SRS, JCT, NSDC, PDS, and WAJP have received payment for board membership; JCT, FYA, NSDC, XC, PDS, PN, FXB, BR, and TFS have received payment for lectures, including service on speakers bureau; AS, FYA, NSDC, PDS, FXB, and BR have received payment for development of educational presentations; and NSDC, JS, WAJP, JCT, SRS, PN, XC, FXB, UJ, FYA, JH, SMG, AM, AS, and CMW have received travel reimbursements from GlaxoSmithKline Biologicals or Merck Sharp & Dohme (Sanofi Pasteur MSD), or both. DA has received support for travel from Vaestoliitto. S-NC, KP, MJVG, and GL declare that they have no conflicts of interest. This study (NCT00122681/580299/008) was funded and coordinated by GlaxoSmithKline Biologicals. We thank study participants and their families. We thank Mary Greenacre for writing and editorial assistance, and Jenny Andersson (Cromsource) for editorial assistance and manuscript coordination on behalf of GlaxoSmithKline Biologicals, Wavre, Belgium.