|
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
| |
|
Author
|
|
|
|
| |
|
Institution/Organisation
|
|
|
|
HPV PATRICIA Study Group
| |
|
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. |
| |
|
Language
|
|
|
|
English
| |
|
Source (journal)
|
|
|
|
International journal of cancer. - New York, N.Y.
| |
|
Publication
|
|
|
|
New York, N.Y.
:
2012
| |
|
ISSN
|
|
|
|
0020-7136
| |
|
DOI
|
|
|
|
10.1002/IJC.26362
| |
|
Volume/pages
|
|
|
|
131
:1
(2012)
, p. 106-116
| |
|
ISI
|
|
|
|
000303050100011
| |
|
Full text (Publisher's DOI)
|
|
|
|
| |
|
Full text (publisher's version - intranet only)
|
|
|
|
| |
|