Efficacy of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in women aged 15-25 years with and without serological evidence of previous exposure to HPV-16/18
A Szarewski, W A J Poppe, S R Skinner, C M Wheeler, J Paavonen, P Naud, J Salmeron, S-N Chow, D Apter, H Kitchener, X Castellsagué, J C Teixeira, J Hedrick, U Jaisamrarn, G Limson, S Garland, B Romanowski, F Y Aoki, T F Schwarz, F X Bosch, D M Harper, K Hardt, T Zahaf, D Descamps, F Struyf, M Lehtinen, G Dubin, HPV PATRICIA Study Group, I Denham, S Garland, A Mindel, M O'Sullivan, S R Skinner, R Waddell, P Naud, J C Teixeira, P De Sutter, W A J Poppe, W Tjalma, F Y Aoki, F Diaz-Mitoma, M Dionne, L Ferguson, M Miller, K Papp, B Ramjattan, B Romanowski, R Somani, D Apter, S Astikainen, T Karppa, M Kekki, H Keranen, N Kudjoi, M Kuortti, M Kupari, L Kyha-Osterlund, R Isaksson, M Lehtinen, H Levanen, T Liljamo, K Loonberg, L Niemi, J Paavonen, J Palmroth, T Petaja, S Rekonen, U Romppanen, M Siitari-Mattila, L Tuomivaara, M Vilkki, K H Belling, T Gent, T Grubert, W Harlfi nger, A Holst, W D Hopker, S Jensen-El Tobgui, G Merder, K Peters, S Schoenian, K Schulze, T F Schwarz, C Wackernagel, F Boselli, G Mojana, J Salmeron, G Benitez, C Crisostomo, R Del Rosario- Raymundo, M J Germar, G Limson, J Raymundo, M C Remollino, G Villanueva, S Villanueva, J D Zamora, L Zamora, J Bajo, J Bayas, M Campins, X Castellsagué, M Castro, C Centeno, F Cruzet, L Rodriguez, A Torne, J A Vidart, S-N Chow, M H Yu, C C Yuan, S-C Huang, H-N Ho, R-J Chen, H-H Lin, T-Y Chu, S Angsuwathana, U Jaisamrarn, K Wilawan, U K E Abdulhakim, M Cruickshank, H Kitchener, D Lewis, I Pavel, J Robinson, A Szarewski, R Ackerman, K Ault, N Bennett, M Caldwell, C Chambers, A Chatterjee, L Civitarese, L Demars, T De Santis, L Downs, D Ferris, P Fine, S Gall, D M Harper, J Hedrick, W Herzig, M Hiraoka, W Huh, L Kamemoto, T Klein, W Koltun, A Kong, J Lalezari, P Lee, L Leeman, S Luber, M Martens, J Michelson, W Nebel, C Peterson, K Pitts, J Rosen, W Rosenfeld, M Scutella, L Seidman, M Sperling, R Sperling, M Stager, J Stapleton, K Swenson, C Thoming, L Twiggs, A Waldbaum, C M Wheeler, M Yardley, E Zbella, N Kiviat, K P Klugman, P Nieminen, C Bergeron, E Eisenstein, R Karron, R Marks, T Nolan, S K Tay, S Albers, P Bollaerts, A Camier, B Colau, A De Breyne, S Genevrois, Z Issaka, N Martens, P Peeters, N Smoes, B Spiessens, F Tavares, A Tonglet, S Vanden-Dunghen, A S Vilain, K R Ward, E Alt, B Iskaros, A Limaye, X Liu-Jarin, R D Luff, M McNeeley, C Provenzano, B Winkler, A Molijn, W Quint, L Struijk, M Van de Sandt, L J Van Doorn, S Poncelet, V Xhenseval, A Szarewski, W A J Poppe, S R Skinner, C M Wheeler, J Paavonen, P Naud, J Salmeron, S-N Chow, D Apter, H Kitchener, X Castellsagué, J C Teixeira, J Hedrick, U Jaisamrarn, G Limson, S Garland, B Romanowski, F Y Aoki, T F Schwarz, F X Bosch, D M Harper, K Hardt, T Zahaf, D Descamps, F Struyf, M Lehtinen, G Dubin, HPV PATRICIA Study Group, I Denham, S Garland, A Mindel, M O'Sullivan, S R Skinner, R Waddell, P Naud, J C Teixeira, P De Sutter, W A J Poppe, W Tjalma, F Y Aoki, F Diaz-Mitoma, M Dionne, L Ferguson, M Miller, K Papp, B Ramjattan, B Romanowski, R Somani, D Apter, S Astikainen, T Karppa, M Kekki, H Keranen, N Kudjoi, M Kuortti, M Kupari, L Kyha-Osterlund, R Isaksson, M Lehtinen, H Levanen, T Liljamo, K Loonberg, L Niemi, J Paavonen, J Palmroth, T Petaja, S Rekonen, U Romppanen, M Siitari-Mattila, L Tuomivaara, M Vilkki, K H Belling, T Gent, T Grubert, W Harlfi nger, A Holst, W D Hopker, S Jensen-El Tobgui, G Merder, K Peters, S Schoenian, K Schulze, T F Schwarz, C Wackernagel, F Boselli, G Mojana, J Salmeron, G Benitez, C Crisostomo, R Del Rosario- Raymundo, M J Germar, G Limson, J Raymundo, M C Remollino, G Villanueva, S Villanueva, J D Zamora, L Zamora, J Bajo, J Bayas, M Campins, X Castellsagué, M Castro, C Centeno, F Cruzet, L Rodriguez, A Torne, J A Vidart, S-N Chow, M H Yu, C C Yuan, S-C Huang, H-N Ho, R-J Chen, H-H Lin, T-Y Chu, S Angsuwathana, U Jaisamrarn, K Wilawan, U K E Abdulhakim, M Cruickshank, H Kitchener, D Lewis, I Pavel, J Robinson, A Szarewski, R Ackerman, K Ault, N Bennett, M Caldwell, C Chambers, A Chatterjee, L Civitarese, L Demars, T De Santis, L Downs, D Ferris, P Fine, S Gall, D M Harper, J Hedrick, W Herzig, M Hiraoka, W Huh, L Kamemoto, T Klein, W Koltun, A Kong, J Lalezari, P Lee, L Leeman, S Luber, M Martens, J Michelson, W Nebel, C Peterson, K Pitts, J Rosen, W Rosenfeld, M Scutella, L Seidman, M Sperling, R Sperling, M Stager, J Stapleton, K Swenson, C Thoming, L Twiggs, A Waldbaum, C M Wheeler, M Yardley, E Zbella, N Kiviat, K P Klugman, P Nieminen, C Bergeron, E Eisenstein, R Karron, R Marks, T Nolan, S K Tay, S Albers, P Bollaerts, A Camier, B Colau, A De Breyne, S Genevrois, Z Issaka, N Martens, P Peeters, N Smoes, B Spiessens, F Tavares, A Tonglet, S Vanden-Dunghen, A S Vilain, K R Ward, E Alt, B Iskaros, A Limaye, X Liu-Jarin, R D Luff, M McNeeley, C Provenzano, B Winkler, A Molijn, W Quint, L Struijk, M Van de Sandt, L J Van Doorn, S Poncelet, V Xhenseval
Abstract
In the Phase III PATRICIA study (NCT00122681), the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine (Cervarix(®), GlaxoSmithKline Biologicals) was highly efficacious against HPV-16/18 infections and precancerous lesions in women HPV-16/18 deoxyribose nucleic acid (DNA) negative and seronegative at baseline. We present further data on vaccine efficacy (VE) against HPV-16/18 in the total vaccinated cohort including women who may have been exposed to HPV-16/18 infection before vaccination. In women with no evidence of current or previous HPV-16/18 infection (DNA negative and seronegative), VE was 90.3% (96.1% confidence interval: 87.3-92.6) against 6-month persistent infection (PI), 91.9% (84.6-96.2) against cervical intraepithelial neoplasia (CIN)1+ and 94.6% (86.3-98.4) against CIN2+ [97.7% (91.1-99.8) when using the HPV type assignment algorithm (TAA)]. In women HPV-16/18 DNA negative but with serological evidence of previous HPV-16/18 infection (seropositive), VE was 72.3% (53.0-84.5) against 6-month PI, 67.2% (10.9-89.9) against CIN1+, and 68.8% (-28.3-95.0) against CIN2+ [88.5% (10.8-99.8) when using TAA]. In women with no evidence of current HPV-16/18 infection (DNA negative), regardless of their baseline HPV-16/18 serological status, VE was 88.7% (85.7-91.1) against 6-month PI, 89.1% (81.6-94.0) against CIN1+ and 92.4% (84.0-97.0) against CIN2+ [97.0% (90.6-99.5) when using TAA]. In women who were DNA positive for one vaccine type, the vaccine was efficacious against the other vaccine type. The vaccine did not impact the outcome of HPV-16/18 infections present at the time of vaccination. Vaccination was generally well tolerated regardless of the woman's HPV-16/18 DNA or serological status at entry.
Copyright © 2011 UICC.
Source: PubMed