Journal article
Efficacy of the HPV-16/18 AS04-adjuvanted vaccine against low-risk HPV types (PATRICIA Randomized Trial): An unexpected observation
A Szarewski, SR Skinner, SM Garland, B Romanowski, TF Schwarz, D Apter, SN Chow, J Paavonen, MR Del Rosario-Raymundo, JC Teixeira, NS De Carvalho, M Castro-Sanchez, X Castellsagué, WAJ Poppe, P De Sutter, W Huh, A Chatterjee, WA Tjalma, RT Ackerman, M Martens Show all
Journal of Infectious Diseases | OXFORD UNIV PRESS INC | Published : 2013
Abstract
Background. Public Health England has reported a decrease of up to 20.8% in new diagnoses of external genital warts (GWs) among women aged <19 years since the national vaccination program with the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine began in 2008. A post hoc analysis of the phase III PATRICIA (PApilloma TRIal against Cancer In young Adults) trial (NCT00122681) was performed to ascertain whether protection against low-risk HPV types was apparent.Methods. Vaccine efficacy (VE) at 48 months was assessed against 6-month persistent infection (6MPI) with low-risk HPV types in the total vaccinated cohort (TVC) and in the TVC naive (for 25 HPV types tested) populations.Results. ..
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Funding Acknowledgements
This work (NCT00122681) was supported by the GlaxoSmithKline group of companies, which designed the study in collaboration with investigators and coordinated collection, analysis, and interpretation of data. Investigators from the PATRICIA Study Group collected data for the trial and cared for the subjects. The authors had full access to all the trial data and had final responsibility for the decision to submit for publication.