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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
Authors: Szarewski, A ×
Poppe, Willy
Skinner, S R
Wheeler, C M
Paavonen, J
Naud, P
Salmeron, J
Chow, S-N
Apter, D
Kitchener, H
Castellsagué, X
Teixeira, J C
Hedrick, J
Jaisamrarn, U
Limson, G
Garland, S
Romanowski, B
Aoki, F Y
Schwarz, T F
Bosch, F X
Harper, D M
Hardt, K
Zahaf, T
Descamps, D
Struyf, F
Lehtinen, M
Dubin, G
for the HPV PATRICIA Study Group #
Issue Date: Jul-2012
Publisher: Wiley-Liss
Series Title: International journal of cancer. Journal international du cancer vol:131 issue:1 pages:106-16
Article number: 10.1002/ijc.26362
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.
URI: 
ISSN: 0020-7136
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Basic Research in Gynaecology Section (-)
× corresponding author
# (joint) last author

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