Prophylactic efficacy of a quadrivalent human papillomavirus (HPV) vaccine in women with virological evidence of HPV infection

J Infect Dis. 2007 Nov 15;196(10):1438-46. doi: 10.1086/522864. Epub 2007 Oct 31.

Abstract

Background: A quadrivalent (types 6, 11, 16, and 18) human papillomavirus (HPV) L1 virus-like-particle (VLP) vaccine has been shown to be 95%-100% effective in preventing cervical and genital disease related to HPV-6, -11, -16, and -18 in 16-26-year-old women naive for HPV vaccine types. Because most women in the general population are sexually active, some will have already been infected with > or =1 HPV vaccine types at the time vaccination is offered. Here, we assessed whether such infected women are protected against disease caused by the remaining HPV vaccine types.

Methods: Two randomized, placebo-controlled trials of the quadrivalent (types 6, 11, 16, and 18) HPV vaccine enrolled 17,622 women without consideration of baseline HPV status. Among women infected with 1-3 HPV vaccine types at enrollment, efficacy against genital disease related to the HPV vaccine type or types for which subjects were naive was assessed.

Results: Vaccination was 100% effective (95% confidence interval [CI], 79%-100%) in preventing incident cervical intraepithelial neoplasia 2 or 3 or cervical adenocarcinoma in situ caused by the HPV type or types for which the women were negative at enrollment. Efficacy for preventing vulvar or vaginal HPV-related lesions was 94% (95% CI, 81%-99%).

Conclusions: Among women positive for 1-3 HPV vaccine types before vaccination, the quadrivalent HPV vaccine protected against neoplasia caused by the remaining types. These results support vaccination of the general population without prescreening.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Antibodies, Viral / blood
  • Cervical Intraepithelial Neoplasia / prevention & control
  • Cervical Intraepithelial Neoplasia / virology
  • DNA, Viral / analysis
  • Double-Blind Method
  • Enzyme-Linked Immunosorbent Assay
  • Female
  • Humans
  • Injections, Intramuscular
  • Papillomaviridae / classification*
  • Papillomaviridae / genetics
  • Papillomaviridae / immunology
  • Papillomavirus Infections / prevention & control*
  • Papillomavirus Infections / virology
  • Papillomavirus Vaccines / administration & dosage
  • Papillomavirus Vaccines / therapeutic use*
  • Polymerase Chain Reaction
  • Prospective Studies
  • Sexually Transmitted Diseases, Viral / prevention & control*
  • Sexually Transmitted Diseases, Viral / virology
  • Treatment Outcome
  • Uterine Cervical Neoplasms / prevention & control
  • Uterine Cervical Neoplasms / virology

Substances

  • Antibodies, Viral
  • DNA, Viral
  • Papillomavirus Vaccines