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

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

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, …
The Journal of infectious diseases, Vol.208(9), pp.1391-1396
11/01/2013
DOI: 10.1093/infdis/jit360
PMCID: PMC3789574
PMID: 24092907
url
https://doi.org/10.1093/infdis/jit360View
Published (Version of record) Open Access

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.
genital warts Major and Brief Reports HPV vaccine human papillomavirus HPV

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