title: Immunogenicity and tolerability of an HPV-16/18 AS04-adjuvanted prophylactic cervical cancer vaccine in women aged 15-55 years.
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.
authors.affiliation: Stiftung Juliusspital Würzburg, Zentrallabor, Juliuspromenade 19, D-97070 Würzburg, Germany. tschwarz@juliusspital.de
authors.forename: Tino F
authors.initials: TF
authors.lastname: Schwarz
authors.forename: Marek
authors.initials: M
authors.lastname: Spaczynski
authors.forename: Achim
authors.initials: A
authors.lastname: Schneider
authors.forename: Jacek
authors.initials: J
authors.lastname: Wysocki
authors.forename: Andrzej
authors.initials: A
authors.lastname: Galaj
authors.forename: Pamela
authors.initials: P
authors.lastname: Perona
authors.forename: Sylviane
authors.initials: S
authors.lastname: Poncelet
authors.forename: Toufik
authors.initials: T
authors.lastname: Zahaf
authors.forename: Karin
authors.initials: K
authors.lastname: Hardt
authors.forename: Dominique
authors.initials: D
authors.lastname: Descamps
authors.forename: Gary
authors.initials: G
authors.lastname: Dubin
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use; D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000276:immunology; D005260:Female; D052162:Human papillomavirus 16 / Q000187:drug effects / Q000276:immunology; D052161:Human papillomavirus 18 / Q000187:drug effects / Q000276:immunology; D006801:Humans; D030361:Papillomavirus Infections / Q000276:immunology* / Q000517:prevention & control*; D053918:Papillomavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000737:chemistry / Q000276:immunology; D012449:Safety; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000276:immunology / Q000517:prevention & control*
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D053918:Papillomavirus Vaccines