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Clinical Trial
. 2009 Jan 22;27(4):581-7.
doi: 10.1016/j.vaccine.2008.10.088. Epub 2008 Nov 18.

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

Tino F Schwarz  1 , Marek Spaczynski, Achim Schneider, Jacek Wysocki, Andrzej Galaj, Pamela Perona, Sylviane Poncelet, Toufik Zahaf, Karin Hardt, Dominique Descamps, Gary Dubin; HPV Study Group for Adult Women
Affiliations
Clinical Trial

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

Tino F Schwarz et al. Vaccine. .

Abstract

The immunogenicity and safety of an HPV-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 1 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.

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