Efficacy of the HPV-16/18 AS04-Adjuvanted Vaccine Against Low-Risk HPV Types (PATRICIA Randomized Trial): An Unexpected Observation

نویسندگان

  • Anne Szarewski
  • S. Rachel Skinner
  • Suzanne M. Garland
  • Barbara Romanowski
  • Tino F. Schwarz
  • Dan Apter
  • Song-Nan Chow
  • Jorma Paavonen
  • M. Rowena Del Rosario-Raymundo
  • Julio C. Teixeira
  • Newton S. De Carvalho
  • Maria Castro-Sanchez
  • Xavier Castellsagué
  • Willy A. J. Poppe
  • Philippe De Sutter
  • Warner Huh
  • Archana Chatterjee
  • Wiebren A. Tjalma
  • Ronald T. Ackerman
  • Mark Martens
  • Kim A. Papp
  • Jose Bajo-Arenas
  • Diane M. Harper
  • Aureli Torné
  • Marie-Pierre David
  • Frank Struyf
  • Matti Lehtinen
  • Gary Dubin
چکیده

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.

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عنوان ژورنال:

دوره 208  شماره 

صفحات  -

تاریخ انتشار 2013