The Journal of infectious diseases · 2013
Efficacy of the HPV-16/18 AS04-adjuvanted vaccine against low-risk HPV types (PATRICIA randomized trial): an unexpected observation.
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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, Martens Mark, Papp Kim A, Bajo-Arenas Jose, Harper Diane M, Torné Aureli, David Marie-Pierre, Struyf Frank, Lehtinen Matti, Dubin Gary
Аннотация
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.
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.
Предметные рубрики MeSH
Adjuvants, ImmunologicAluminum HydroxideClinical Trials, Phase III as TopicCondylomata AcuminataDouble-Blind MethodFemaleHuman papillomavirus 16Human papillomavirus 18Human papillomavirus 6HumansIncidenceIncidental FindingsLipid AMulticenter Studies as TopicPapillomavirus VaccinesRandomized Controlled Trials as TopicTreatment OutcomeVaccination