Journal article

Efficacy of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in women aged 15-25 years with and without serological evidence of previous exposure to HPV-16/18

A Szarewski, WAJ Poppe, SR Skinner, CM Wheeler, J Paavonen, P Naud, J Salmeron, S-N Chow, D Apter, H Kitchener, X Castellsague, JC Teixeira, J Hedrick, U Jaisamrarn, G Limson, S Garland, B Romanowski, FY Aoki, TF Schwarz, FX Bosch Show all



In the Phase III PATRICIA study (NCT00122681), the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine (Cervarix(®), GlaxoSmithKline Biologicals) was highly efficacious against HPV-16/18 infections and precancerous lesions in women HPV-16/18 deoxyribose nucleic acid (DNA) negative and seronegative at baseline. We present further data on vaccine efficacy (VE) against HPV-16/18 in the total vaccinated cohort including women who may have been exposed to HPV-16/18 infection before vaccination. In women with no evidence of current or previous HPV-16/18 infection (DNA negative and seronegative), VE was 90.3% (96.1% confidence interval: 87.3-92.6) against 6-month persistent infection (PI), 91...

View full abstract


Awarded by GlaxoSmithKline Biologicals

Funding Acknowledgements

DD, GD, FS, KH, and TZ are employees of GlaxoSmithKline Biologicals. DD, GD, FS and KH 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. PN, SRS, FYA, SG, ML, JCT, TFS, CMW, WAJP, DMH, FXB, XC and BR have received funding through their institutions to do other HPV vaccine studies for GlaxoSmithKline Biologicals and/or Merck & Co., Inc. Sharp & Dohme, Sanofi Pasteur MSD. CMW has also received reagents and equipment through her institution from Roche Molecular Systems to do HPV genotyping studies. SG has received advisory board fees and grant support from CSL and GlaxoSmithKline. SG has received lecture fees from Merck, GSK and Sanofi Pasteur. FXB, XC, PN, WAJP, BR, AS and JCT have received consulting fees in the past 3 years. FXB has received payment for participating in speakers bureau. JCT, TFS, BR and DMH have received payments from Merck and/or GlaxoSmithKline Biologicals for participating in advisory boards. SG is a member of the Merck Global Advisory Board as well as the Merck Scientific Advisory Committee for HPV. DMH, FYA, XC, PN, BR, TFS, SRS, AS and WJAP have received honoraria, paid expert testimony, or travel grants from GlaxoSmithKline Biologicals. JS, JP, JH, HK, DA, S-NC, UJ and GL declare that they have no conflicts of interest.The study (NCT00122681) was funded by GlaxoSmithKline Biologicals. The authors thank study participants and their families. AS, WAJP, SRS, FXB, DMH, CMW, KH and DD formed the core writing team for the report. All authors reviewed and commented on a draft of the report and gave final approval to submit for publication. Editorial assistance in the preparation of this article was provided by Meridian HealthComms Ltd; support for this assistance was funded by GlaxoSmithKline Biologicals. Editorial support and article coordination were provided by S Geelissen, GlaxoSmithKline Biologicals, Belgium.