Title
Efficacy of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in women aged 1525 years with and without serological evidence of previous exposure to HPV-16/18 Efficacy of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in women aged 1525 years with and without serological evidence of previous exposure to HPV-16/18
Author
Contributor
Tjalma, Wiebren A.
Author
Faculty/Department
Faculty of Medicine and Health Sciences
Publication type
article
Publication
New York, N.Y. ,
Subject
Human medicine
Source (journal)
International journal of cancer. - New York, N.Y.
Volume/pages
131(2012) :1 , p. 106-116
ISSN
0020-7136
ISI
000303050100011
Carrier
E
Target language
English (eng)
Full text (Publishers DOI)
Affiliation
University of Antwerp
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: 87.392.6) against 6-month persistent infection (PI), 91.9% (84.696.2) against cervical intraepithelial neoplasia (CIN)1+ and 94.6% (86.398.4) against CIN2+ [97.7% (91.199.8) 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% (53.084.5) against 6-month PI, 67.2% (10.989.9) against CIN1+, and 68.8% (−28.395.0) against CIN2+ [88.5% (10.899.8) 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% (85.791.1) against 6-month PI, 89.1% (81.694.0) against CIN1+ and 92.4% (84.097.0) against CIN2+ [97.0% (90.699.5) 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.
E-info
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