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

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

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

  • Clinical Trial, Phase III
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adjuvants, Immunologic / therapeutic use
  • Adolescent
  • Adult
  • Antibodies, Viral / immunology
  • Cervical Intraepithelial Neoplasia / immunology
  • Cervical Intraepithelial Neoplasia / prevention & control*
  • Female
  • Human papillomavirus 16 / drug effects
  • Human papillomavirus 16 / immunology
  • Human papillomavirus 18 / drug effects
  • Human papillomavirus 18 / immunology
  • Humans
  • Papillomavirus Infections / immunology*
  • Papillomavirus Infections / prevention & control*
  • Papillomavirus Vaccines* / administration & dosage
  • Papillomavirus Vaccines* / adverse effects
  • Papillomavirus Vaccines* / chemistry
  • Papillomavirus Vaccines* / immunology
  • Safety
  • Young Adult

Substances

  • Adjuvants, Immunologic
  • Antibodies, Viral
  • Papillomavirus Vaccines