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.
Publication types
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Clinical Trial, Phase III
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Multicenter Study
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Research Support, Non-U.S. Gov't
MeSH terms
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Adjuvants, Immunologic / therapeutic use
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Adolescent
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Adult
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Antibodies, Viral / immunology
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Female
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Human papillomavirus 16 / drug effects
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Human papillomavirus 16 / immunology
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Human papillomavirus 18 / drug effects
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Human papillomavirus 18 / immunology
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Humans
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Papillomavirus Infections / immunology*
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Papillomavirus Infections / prevention & control*
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Papillomavirus Vaccines* / administration & dosage
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Papillomavirus Vaccines* / adverse effects
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Papillomavirus Vaccines* / chemistry
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Papillomavirus Vaccines* / immunology
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Safety
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Uterine Cervical Dysplasia / immunology
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Uterine Cervical Dysplasia / prevention & control*
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Young Adult
Substances
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Adjuvants, Immunologic
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Antibodies, Viral
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Papillomavirus Vaccines