Title: Efficacy of the HPV-16/18 AS04-Adjuvanted Vaccine Against Low-Risk HPV Types (PATRICIA Randomized Trial): An Unexpected Observation
Authors: Szarewski, Anne ×
Skinner, S Rachel
Garland, Suzanne M
Romanowski, Barbara
Schwarz, Tino F
Apter, Dan
Chow, Song-Nan
Paavonen, Jorma
Del Rosario-Raymundo, M Rowena
Teixeira, Julio C
De Carvalho, Newton S
Castro-Sanchez, Maria
Castellsagué, Xavier
Poppe, Willy
De Sutter, Philippe
Huh, Warner
Chatterjee, Archana
Tjalma, Wiebren A
Ackerman, Ronald T
Martens, Mark
Papp, Kim A
Bajo-Arenas, Jose
Harper, Diane M
Torné, Aureli
David, Marie-Pierre
Struyf, Frank
Lehtinen, Matti
Dubin, Gary #
Issue Date: Nov-2013
Publisher: Published by the University of Chicago Press for the Infectious Diseases Society of America
Series Title: The Journal of Infectious Diseases vol:208 issue:9 pages:1391-1396
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. In the TVC naive cohort, VE against 6MPI (95% confidence interval) was 34.5% (11.3 to 51.8) for HPV-6/11, 34.9% (9.1 to 53.7) for HPV-6, 30.3% (-45.0 to 67.5) for HPV-11, and 49.5% (21.0 to 68.3) for HPV-74. Conclusions. The HPV-16/18 AS04-adjuvanted vaccine appears to have moderate efficacy against persistent infections with a number of low-risk HPV types (HPV-6/11/74), which are responsible for the majority of external GWs, and recently, antibody and cell-mediated immune response to HPV-6/11 have been observed. These findings may help to explain the decrease in external GW diagnoses seen in England.
ISSN: 0022-1899
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Organ Systems (+)
Department of Health and Technology - UC Leuven
× corresponding author
# (joint) last author

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