Immunogenicity and tolerability of an HPV-16/18 AS04-adjuvanted prophylactic cervical cancer vaccine in women aged 15-55 years.
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.
Schwarz
Tino F
TF
Stiftung Juliusspital Würzburg, Zentrallabor, Juliuspromenade 19, D-97070 Würzburg, Germany. tschwarz@juliusspital.de
Spaczynski
Marek
M
Schneider
Achim
A
Wysocki
Jacek
J
Galaj
Andrzej
A
Perona
Pamela
P
Poncelet
Sylviane
S
Zahaf
Toufik
T
Hardt
Karin
K
Descamps
Dominique
D
Dubin
Gary
G
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*
D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D053918:Papillomavirus Vaccines