1. Efficacy of the HPV-16/18 AS04-Adjuvanted Vaccine Against Low-Risk HPV Types (PATRICIA Randomized Trial): An Unexpected Observation.
- Author
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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 A. J., De Sutter, Philippe, Huh, Warner, Chatterjee, Archana, Tjalma, Wiebren A., Ackerman, Ronald T., and Martens, Mark
- Subjects
HUMAN papillomavirus vaccines ,GENITAL warts ,DISEASES in women ,DRUG efficacy ,PUBLIC health ,DIAGNOSIS - 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. [ABSTRACT FROM PUBLISHER]
- Published
- 2013
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