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

Schwarz, Tino F; Spaczynski, Marek; Schneider, Achim; Wysocki, Jacek; Galaj, Andrzej; Perona, Pamela; Poncelet, Sylviane; Zahaf, Toufik; Hardt, Karin; Descamps, Dominique; Dubin, Gary.
Vaccine; 27(4): 581-7, 2009 Jan 22.
Artigo em Inglês | MEDLINE | 2009 | ID: mdl-19022320
Resumo: 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.