Immunogenicity and tolerability of an HPV-16/18 AS04-adjuvanted prophylactic cervical cancer vaccine in women aged 15-55 years

被引:113
作者
Schwarz, Tino F. [1 ]
Spaczynski, Marek [2 ]
Schneider, Achim [3 ,4 ]
Wysocki, Jacek [5 ]
Galaj, Andrzej [6 ]
Perona, Pamela [7 ]
Poncelet, Sylviane [8 ]
Zahaf, Toufik [8 ]
Hardt, Karin [8 ]
Descamps, Dominique [8 ]
Dubin, Gary [9 ]
机构
[1] Stiftung Juliusspital Wurzburg, D-97070 Wurzburg, Germany
[2] Katedra Ginekol Poloznictwa Klin Onkol, Poznan, Poland
[3] Charite, D-12200 Berlin, Germany
[4] Dept Gynaecol, Berlin, Germany
[5] Univ Sch Med Sci, Dept Prevent Med, Poznan, Poland
[6] Vitamed Bydgoszcz, Bydgoszcz, Poland
[7] Univ Munich, Dept Trop Med & Infect Dis, D-80802 Munich, Germany
[8] GlaxoSmithKline Biol, B-1330 Rixensart, Belgium
[9] GlaxoSmithKline Biol, King Of Prussia, PA 19406 USA
关键词
AS04; Adjuvant; Cervical cancer; HPV; Immunization; HUMAN-PAPILLOMAVIRUS TYPE-16; HEPATITIS-B-VACCINE; PARTICLE VACCINE; YOUNG-WOMEN; FOLLOW-UP; EFFICACY; INFECTION; PREVALENCE; ANTIBODIES; LESIONS;
D O I
10.1016/j.vaccine.2008.10.088
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
The immunogenicity and safety of an HIIV-16/18 AS04-adjuvanted vaccine were assessed in women aged 26-55 years and compared with women aged 15-25 years in a Phase III, non-randomised, open-label, age-stratified study. Overall the vaccine was well tolerated and 100% seropositivity was achieved I month after the third dose in all age groups. There was a high correlation between HPV-16 and HPV-18 antibody levels (IgG) in cervicovaginal secretions and sera, regardless of age. The HPV-16/18 AS04-adjuvanted vaccine induces a robust and persistent immune response in women >26 years of age and generates antibodies that transudate through the cervix epithelium. (C) 2008 Elsevier Ltd. All rights reserved.
引用
收藏
页码:581 / 587
页数:7
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