Human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for the prevention of cervical cancer and HPV-related diseases

Expert Rev Vaccines. 2016;15(3):367-87. doi: 10.1586/14760584.2016.1124763.

Abstract

Vaccines are available against human papillomavirus (HPV), the causal agent of cervical and other cancers. Efficacy data from the HPV-16/18 AS04-adjuvanted vaccine clinical trial program were reviewed. Six randomized, controlled phase II/III trials evaluating cervical endpoints enrolled women from diverse populations and geographical locations. The program analyzed extensively the cohorts most relevant from a public health perspective: the total vaccinated cohort (TVC), approximating a general population including those with existing or previous HPV infection, and TVC-naïve, approximating a population of young women before sexual debut. Results show that the vaccine reduces HPV-16/18 infection and associated cervical endpoints in women regardless of age, location, or sexual experience. It provides cross-protection against some non-vaccine oncogenic HPV types and types causing genital warts, and may be effective against vulvar, oral, and anal HPV infection. Early epidemiology data following its introduction suggest a decline in the prevalence of vaccine and some non-vaccine HPV types.

Keywords: Cervical cancer; HPV; efficacy; human papillomavirus; literature review; randomized controlled trial; vaccination.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Adjuvants, Immunologic / administration & dosage*
  • Aluminum Hydroxide / administration & dosage*
  • Anus Neoplasms / epidemiology
  • Anus Neoplasms / prevention & control
  • Clinical Trials, Phase II as Topic
  • Clinical Trials, Phase III as Topic
  • Condylomata Acuminata / epidemiology
  • Condylomata Acuminata / prevention & control
  • Female
  • Human papillomavirus 16 / immunology*
  • Human papillomavirus 18 / immunology*
  • Humans
  • Lipid A / administration & dosage
  • Lipid A / analogs & derivatives*
  • Mouth Neoplasms / epidemiology
  • Mouth Neoplasms / prevention & control
  • Papillomavirus Infections / complications
  • Papillomavirus Infections / epidemiology
  • Papillomavirus Infections / prevention & control*
  • Papillomavirus Vaccines / administration & dosage
  • Papillomavirus Vaccines / immunology*
  • Randomized Controlled Trials as Topic
  • Uterine Cervical Neoplasms / prevention & control*

Substances

  • ASO4 mixture
  • Adjuvants, Immunologic
  • Lipid A
  • Papillomavirus Vaccines
  • Aluminum Hydroxide