학술논문
Efficacy of the AS04-adjuvanted HPV-16/18 vaccine: Pooled analysis of the Costa Rica Vaccine and PATRICIA randomized controlled trials
Document Type
article
Author
Tota, Joseph E; Struyf, Frank; Sampson, Joshua N; Gonzalez, Paula; Ryser, Martin; Herrero, Rolando; Schussler, John; Karkada, Naveen; Rodriguez, Ana Cecilia; Folschweiller, Nicolas; Porras, Carolina; Schiffman, Mark; Schiller, John T; Quint, Wim; Kreimer, Aimée R; Wheeler, Cosette M; Hildesheim, Allan; Cortés, Bernal; González, Paula; Jiménez, Silvia E; Rodríguez, Ana Cecilia; Lowy, Douglas R; Wacholder, Sholom; Pinto, Ligia A; Kemp, Troy J; van Doorn, Leen-Jan; Struijk, Linda; Palefsky, Joel M; Darragh, Teresa M; Stoler, Mark H; Garland, SM; Skinner, SR; De Sutter, P; Poppe, WAJ; De Carvalho, NS; Teixeira, JC; Ferguson, L; Ferguson, M; Papp, K; Ramjattan, B; Orr, PH; Paavonen, J; Höpker, WD; Tobgui, S Jensen-El; Liverani, CA; Limson, GM; Marti, M Campins; Castro, M; Centeno, C; Chow, SN; Angsuwathana, S; Lewis, D; Ackerman, R; Caldwell, M; Chambers, C; Chatterjee, A; Harper, D; Sperling, R; Stapleton, J; Waldbaum, A; Lee, P; Awedikian, Rafi
Source
Journal of the National Cancer Institute. 112(8)
Subject
Language
Abstract
BackgroundThe AS04-adjuvanted HPV16/18 (AS04-HPV16/18) vaccine provides excellent protection against targeted human papillomavirus (HPV) types and a variable degree of cross-protection against others, including types 6/11/31/33/45. High efficacy against any cervical intraepithelial neoplasia grade 3 or greater (CIN3+; >90%) suggests that lower levels of protection may exist for a wide range of oncogenic HPV types, which is difficult to quantify in individual trials. Pooling individual-level data from two randomized controlled trials, we aimed to evaluate AS04-HPV16/18 vaccine efficacy against incident HPV infections and cervical abnormalities .MethodsData were available from the Costa Rica Vaccine Trial (NCT00128661) and Papilloma Trial Against Cancer in Young Adults trial (NCT00122681), two large-scale, double-blind randomized controlled trials of the AS04-HPV16/18 vaccine. Primary analyses focused on disease-free women with no detectable cervicovaginal HPV at baseline.ResultsA total of 12 550 women were included in our primary analyses (HPV arm = 6271, control arm = 6279). Incidence of 6-month persistent oncogenic and nononcogenic infections, excluding known and accepted protected types 6/11/16/18/31/33/45 (focusing on 34/35/39/40/42/43/44/51/52/53/54/56/58/59/66/68/73/70/74), was statistically significantly lower in the HPV arm than in the control arm (efficacy = 9.9%, 95% confidence interval [CI] = 1.7% to 17.4%). Statistically significant efficacy (P