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Type: Artigo de periódico
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
Author: Szarewski, A
Poppe, WAJ
Skinner, SR
Wheeler, CM
Paavonen, J
Naud, P
Salmeron, J
Chow, SN
Apter, D
Kitchener, H
Castellsague, X
Teixeira, JC
Hedrick, J
Jaisamrarn, U
Limson, G
Garland, S
Romanowski, B
Aoki, FY
Schwarz, TF
Bosch, FX
Harper, DM
Hardt, K
Zahaf, T
Descamps, D
Struyf, F
Lehtinen, M
Dubin, G
Abstract: In the Phase III PATRICIA study (NCT00122681), the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine (Cervarix (R), 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.
Subject: human papillomavirus vaccines
human papillomavirus-16
human papillomavirus-18
previous exposure
vaccine efficacy against human papillomavirus-16
Country: EUA
Editor: Wiley-blackwell
Citation: International Journal Of Cancer. Wiley-blackwell, v. 131, n. 1, n. 106, n. 116, 2012.
Rights: fechado
Identifier DOI: 10.1002/ijc.26362
Date Issue: 2012
Appears in Collections:Unicamp - Artigos e Outros Documentos

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