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. 2013 Nov 1;208(9):1391-6.
doi: 10.1093/infdis/jit360.

Efficacy of the HPV-16/18 AS04-adjuvanted vaccine against low-risk HPV types (PATRICIA randomized trial): an unexpected observation

Anne Szarewski  1 , 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
Affiliations

Efficacy of the HPV-16/18 AS04-adjuvanted vaccine against low-risk HPV types (PATRICIA randomized trial): an unexpected observation

Anne Szarewski et al. J Infect Dis. .

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.

Keywords: HPV; HPV vaccine; genital warts; human papillomavirus.

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References

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