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Int J Cancer. 2012 Jul 1;131(1):106-16. doi: 10.1002/ijc.26362. Epub 2011 Oct 23.

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.

Collaborators (184)

Denham I, Garland S, Mindel A, O'Sullivan M, Skinner SR, Waddell R, Naud P, Teixeira JC, De Sutter P, Poppe WA, Tjalma W, Aoki FY, Diaz-Mitoma F, Dionne M, Ferguson L, Miller M, Papp K, Ramjattan B, Romanowski B, Somani R, Apter D, Astikainen S, Karppa T, Kekki M, Keranen H, Kudjoi N, Kuortti M, Kupari M, Kyha-Osterlund L, Isaksson R, Lehtinen M, Levanen H, Liljamo T, Loonberg K, Niemi L, Paavonen J, Palmroth J, Petaja T, Rekonen S, Romppanen U, Siitari-Mattila M, Tuomivaara L, Vilkki M, Belling KH, Gent T, Grubert T, Harlfi nger W, Holst A, Hopker WD, Tobgui SJ, Merder G, Peters K, Schoenian S, Schulze K, Schwarz TF, Wackernagel C, Boselli F, Mojana G, Salmeron J, Benitez G, Crisostomo C, Rosario- Raymundo RD, Germar MJ, Limson G, Raymundo J, Remollino MC, Villanueva G, Villanueva S, Zamora JD, Zamora L, Bajo J, Bayas J, Campins M, Castellsagué X, Castro M, Centeno C, Cruzet F, Rodriguez L, Torne A, Vidart JA, Chow SN, Yu MH, Yuan CC, Huang SC, Ho HN, Chen RJ, Lin HH, Chu TY, Angsuwathana S, Jaisamrarn U, Wilawan K, Abdulhakim UK, Cruickshank M, Kitchener H, Lewis D, Pavel I, Robinson J, Szarewski A, Ackerman R, Ault K, Bennett N, Caldwell M, Chambers C, Chatterjee A, Civitarese L, Demars L, De Santis T, Downs L, Ferris D, Fine P, Gall S, Harper DM, Hedrick J, Herzig W, Hiraoka M, Huh W, Kamemoto L, Klein T, Koltun W, Kong A, Lalezari J, Lee P, Leeman L, Luber S, Martens M, Michelson J, Nebel W, Peterson C, Pitts K, Rosen J, Rosenfeld W, Scutella M, Seidman L, Sperling M, Sperling R, Stager M, Stapleton J, Swenson K, Thoming C, Twiggs L, Waldbaum A, Wheeler CM, Yardley M, Zbella E, Kiviat N, Klugman KP, Nieminen P, Bergeron C, Eisenstein E, Karron R, Marks R, Nolan T, Tay SK, Albers S, Bollaerts P, Camier A, Colau B, De Breyne A, Genevrois S, Issaka Z, Martens N, Peeters P, Smoes N, Spiessens B, Tavares F, Tonglet A, Vanden-Dunghen S, Vilain AS, Ward KR, Alt E, Iskaros B, Limaye A, Liu-Jarin X, Luff RD, McNeeley M, Provenzano C, Winkler B, Molijn A, Quint W, Struijk L, Van de Sandt M, Doorn LJ, Poncelet S, Xhenseval V.

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.

PMID:
21858807
[PubMed - indexed for MEDLINE]
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