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Efficacy of Human Papillomavirus 16 and 18 (HPV-16/18) AS04- adjuvanted vaccine against cervical infection and precancer in young women : final event-driven analysis of the randomized, double- blind PATRICIA trial

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Efficacy of Human Papillomavirus 16 and 18 (HPV-16/18) AS04- adjuvanted vaccine against cervical infection and precancer in young women : final event-driven analysis of the randomized, double- blind PATRICIA trial

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Título Efficacy of Human Papillomavirus 16 and 18 (HPV-16/18) AS04- adjuvanted vaccine against cervical infection and precancer in young women : final event-driven analysis of the randomized, double- blind PATRICIA trial
Autor Apter, Dan L.
Wheeler, Cosette M.
Paavonen, Jorma
Castellsague, Xavier
Garland, Suzanne M.
Skinner, S. Rachel
Naud, Paulo Sergio Viero
Salmerón, Jorge
Chow, Song-Nan
Kitchener, Henry
Teixeira, Júlio César
Jaisamrarn, Unnop
Limson, Genara
Szarewski, Anne
Romanowski, Barbara
Aoki, Fred Y.
Schwarz, Tino F.
Poppe, Willy A. J.
Bosch, F. Xavier
Mindel, Adrian
Sutter, Philippe de
Hardt, K.
Zahaf, Toufik
Descamps, Dominique
Struyf, Frank
Lehtinen, Matti
Dubin, Gary
Abstract We report final event-driven analysis data on the immunogenicity and efficacy of the human papillomavirus 16 and 18 ((HPV- 16/18) AS04-adjuvanted vaccine in young women aged 15 to 25 years from the PApilloma TRIal against Cancer In young Adults (PATRICIA). The total vaccinated cohort (TVC) included all randomized participants who received at least one vaccine dose (vaccine, n 9,319; control, n 9,325) at months 0, 1, and/or 6. The TVC-naive (vaccine, n 5,822; control, n 5,819) had no evidence of high-risk HPV infection at baseline, approximating adolescent girls targeted by most HPV vaccination programs. Mean follow-up was approximately 39 months after the first vaccine dose in each cohort. At baseline, 26% of women in the TVC had evidence of past and/or current HPV-16/18 infection. HPV-16 and HPV-18 antibody titers postvaccination tended to be higher among 15- to 17-year-olds than among 18- to 25-year-olds. In the TVC, vaccine efficacy (VE) against cervical intraepithelial neoplasia grade 1 or greater (CIN1 ), CIN2 , and CIN3 associated with HPV-16/18 was 55.5% (96.1% confidence interval [CI], 43.2, 65.3), 52.8% (37.5, 64.7), and 33.6% ( 1.1, 56.9). VE against CIN1 , CIN2 , and CIN3 irrespective of HPV DNA was 21.7% (10.7, 31.4), 30.4% (16.4, 42.1), and 33.4% (9.1, 51.5) and was consistently significant only in 15- to 17-year-old women (27.4% [10.8, 40.9], 41.8% [22.3, 56.7], and 55.8% [19.2, 76.9]). In the TVC-naive, VE against CIN1 , CIN2 , and CIN3 associated with HPV-16/18 was 96.5% (89.0, 99.4), 98.4% (90.4, 100), and 100% (64.7, 100), and irrespective of HPV DNA it was 50.1% (35.9, 61.4), 70.2% (54.7, 80.9), and 87.0% (54.9, 97.7). VE against 12-month persistent infection with HPV-16/18 was 89.9% (84.0, 94.0), and that against HPV-31/33/45/51 was 49.0% (34.7, 60.3). In conclusion, vaccinating adolescents before sexual debut has a substantial impact on the overall incidence of high-grade cervical abnormalities, and catch-up vaccination up to 18 years of age is most likely effective. (This study has been registered at ClinicalTrials.gov under registration no. NCT001226810.)
Contido em Clinical and vaccine immunology. Washington. Vol. 22, no. 4 (Apr. 2015), p. 361-373
Assunto Adulto jovem
Método duplo-cego
Mulheres
Papillomavirus humano 16
Origem Estrangeiro
Tipo Artigo de periódico
URI http://hdl.handle.net/10183/129943
Arquivos Descrição Formato
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