title: 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.
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.
authors.affiliation: Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK. a.szarewski@qmul.ac.uk
authors.forename: A
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authors.lastname: Szarewski
authors.forename: W A J
authors.initials: WA
authors.lastname: Poppe
authors.forename: S R
authors.initials: SR
authors.lastname: Skinner
authors.forename: C M
authors.initials: CM
authors.lastname: Wheeler
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authors.lastname: Paavonen
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authors.lastname: Salmeron
authors.forename: S-N
authors.initials: SN
authors.lastname: Chow
authors.forename: D
authors.initials: D
authors.lastname: Apter
authors.forename: H
authors.initials: H
authors.lastname: Kitchener
authors.forename: X
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authors.lastname: Castellsagué
authors.forename: J C
authors.initials: JC
authors.lastname: Teixeira
authors.forename: J
authors.initials: J
authors.lastname: Hedrick
authors.forename: U
authors.initials: U
authors.lastname: Jaisamrarn
authors.forename: G
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authors.lastname: Limson
authors.forename: S
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authors.lastname: Garland
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authors.lastname: Romanowski
authors.forename: F Y
authors.initials: FY
authors.lastname: Aoki
authors.forename: T F
authors.initials: TF
authors.lastname: Schwarz
authors.forename: F X
authors.initials: FX
authors.lastname: Bosch
authors.forename: D M
authors.initials: DM
authors.lastname: Harper
authors.forename: K
authors.initials: K
authors.lastname: Hardt
authors.forename: T
authors.initials: T
authors.lastname: Zahaf
authors.forename: D
authors.initials: D
authors.lastname: Descamps
authors.forename: F
authors.initials: F
authors.lastname: Struyf
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authors.lastname: Lehtinen
authors.forename: G
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authors.lastname: Dubin
mesh_terms: D000276:Adjuvants, Immunologic; D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D015331:Cohort Studies; D004279:DNA, Viral / Q000097:blood; D005260:Female; D052162:Human papillomavirus 16 / Q000276:immunology*; D052161:Human papillomavirus 18 / Q000276:immunology*; D006801:Humans; D030361:Papillomavirus Infections / Q000276:immunology* / Q000473:pathology / Q000517:prevention & control* / Q000821:virology; D053918:Papillomavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D016896:Treatment Outcome; D014611:Vaccination; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000473:pathology / Q000517:prevention & control
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D004279:DNA, Viral; D053918:Papillomavirus Vaccines; C510352:human papillomavirus vaccine, L1 type 16, 18