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Showing content from https://pubmed.ncbi.nlm.nih.gov/19586656/ below:

Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women

Clinical Trial

. 2009 Jul 25;374(9686):301-14. doi: 10.1016/S0140-6736(09)61248-4. Epub 2009 Jul 6. Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women P Naud, J Salmerón, C M Wheeler, S-N Chow, D Apter, H Kitchener, X Castellsague, J C Teixeira, S R Skinner, J Hedrick, U Jaisamrarn, G Limson, S Garland, A Szarewski, B Romanowski, F Y Aoki, T F Schwarz, W A J Poppe, F X Bosch, D Jenkins, K Hardt, T Zahaf, D Descamps, F Struyf, M Lehtinen, G Dubin; HPV PATRICIA Study Group

Collaborators, Affiliations

Collaborators

HPV PATRICIA Study Group: I Denham, S Garland, A Mindel, M O'Sullivan, S R Skinner, R Waddell, N de Carvalho, 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 Harlfinger, A Holst, W D Höpker, S Jensen-El Tobgui, G Merder, K Peters, S Schoenian, K Schulze, T Schwarz, C Wackernagel, F Boselli, G Mojana, J Salmerón, 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 Castellsague, M Castro, C Centeno, F Cruzet, L Rodríguez, A Torné, 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, 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 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, Mary Greenacre, Slavka Baronikova, T Zahaf, M-P David, L Declerck, J Dupin, J-L Maroye

Affiliation

¹ Department of Obstetrics and Gynaecology, University of Helsinki, Helsinki, Finland. Jorma.Paavonen@hus.fi

PMID: 19586656
DOI: 10.1016/S0140-6736(09)61248-4

Item in Clipboard

Clinical Trial

Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women

J Paavonen et al. Lancet. 2009.

. 2009 Jul 25;374(9686):301-14. doi: 10.1016/S0140-6736(09)61248-4. Epub 2009 Jul 6. Authors J Paavonen¹, P Naud, J Salmerón, C M Wheeler, S-N Chow, D Apter, H Kitchener, X Castellsague, J C Teixeira, S R Skinner, J Hedrick, U Jaisamrarn, G Limson, S Garland, A Szarewski, B Romanowski, F Y Aoki, T F Schwarz, W A J Poppe, F X Bosch, D Jenkins, K Hardt, T Zahaf, D Descamps, F Struyf, M Lehtinen, G Dubin; HPV PATRICIA Study Group Collaborators

HPV PATRICIA Study Group: I Denham, S Garland, A Mindel, M O'Sullivan, S R Skinner, R Waddell, N de Carvalho, 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 Harlfinger, A Holst, W D Höpker, S Jensen-El Tobgui, G Merder, K Peters, S Schoenian, K Schulze, T Schwarz, C Wackernagel, F Boselli, G Mojana, J Salmerón, 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 Castellsague, M Castro, C Centeno, F Cruzet, L Rodríguez, A Torné, 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, 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 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, Mary Greenacre, Slavka Baronikova, T Zahaf, M-P David, L Declerck, J Dupin, J-L Maroye

Affiliation

¹ Department of Obstetrics and Gynaecology, University of Helsinki, Helsinki, Finland. Jorma.Paavonen@hus.fi

PMID: 19586656
DOI: 10.1016/S0140-6736(09)61248-4

Item in Clipboard

Erratum in

Lancet. 2010 Sep 25;376(9746):1054

Abstract

Background: The human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine was immunogenic, generally well tolerated, and effective against HPV-16 or HPV-18 infections, and associated precancerous lesions in an event-triggered interim analysis of the phase III randomised, double-blind, controlled PApilloma TRIal against Cancer In young Adults (PATRICIA). We now assess the vaccine efficacy in the final event-driven analysis.

Methods: Women (15-25 years) were vaccinated at months 0, 1, and 6. Analyses were done in the according-to-protocol cohort for efficacy (ATP-E; vaccine, n=8093; control, n=8069), total vaccinated cohort (TVC, included all women receiving at least one vaccine dose, regardless of their baseline HPV status; represents the general population, including those who are sexually active; vaccine, n=9319; control, n=9325), and TVC-naive (no evidence of oncogenic HPV infection at baseline; represents women before sexual debut; vaccine, n=5822; control, n=5819). The primary endpoint was to assess vaccine efficacy against cervical intraepithelial neoplasia 2+ (CIN2+) that was associated with HPV-16 or HPV-18 in women who were seronegative at baseline, and DNA negative at baseline and month 6 for the corresponding type (ATP-E). This trial is registered with ClinicalTrials.gov, number NCT00122681.

Findings: Mean follow-up was 34.9 months (SD 6.4) after the third dose. Vaccine efficacy against CIN2+ associated with HPV-16/18 was 92.9% (96.1% CI 79.9-98.3) in the primary analysis and 98.1% (88.4-100) in an analysis in which probable causality to HPV type was assigned in lesions infected with multiple oncogenic types (ATP-E cohort). Vaccine efficacy against CIN2+ irrespective of HPV DNA in lesions was 30.4% (16.4-42.1) in the TVC and 70.2% (54.7-80.9) in the TVC-naive. Corresponding values against CIN3+ were 33.4% (9.1-51.5) in the TVC and 87.0% (54.9-97.7) in the TVC-naive. Vaccine efficacy against CIN2+ associated with 12 non-vaccine oncogenic types was 54.0% (34.0-68.4; ATP-E). Individual cross-protection against CIN2+ associated with HPV-31, HPV-33, and HPV-45 was seen in the TVC.

Interpretation: The HPV-16/18 AS04-adjuvanted vaccine showed high efficacy against CIN2+ associated with HPV-16/18 and non-vaccine oncogenic HPV types and substantial overall effect in cohorts that are relevant to universal mass vaccination and catch-up programmes.

Funding: GlaxoSmithKline Biologicals.

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