A phase I study to evaluate a human papillomavirus (HPV) type 18 L1 VLP vaccine

Vaccine. 2004 Aug 13;22(23-24):3004-7. doi: 10.1016/j.vaccine.2004.02.020.


Human papillomavirus (HPV) infection can cause genital warts and cervical cancer. HPV types 6 and 11 cause >90% of genital wart cases; HPV16 and 18 cause 70% of cervical cancers. A prophylactic HPV (types 6, 11, 16, 18) L1 virus-like particle (VLP) vaccine may substantially reduce the incidence of these lesions. This report describes the results of a phase I study of the HPV18 component of such a vaccine. Forty women were randomized to receive either HPV18 L1 VLP vaccine or placebo. Anti-HPV18 responses were measured using a competitive radioimmunoassay (cRIA). Tolerability was evaluated using vaccination report cards (VRC). The study showed that the HPV18 L1 VLP vaccine was generally well-tolerated and highly immunogenic. Peak anti-HPV18 geometric mean titers (GMT) in vaccines were 60-fold greater than those observed in women following natural HPV18 infection. Further studies of a multivalent HPV L1 VLP vaccines are warranted.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Antibodies, Viral / analysis
  • Antibodies, Viral / biosynthesis
  • Double-Blind Method
  • Female
  • Humans
  • Papillomaviridae / immunology*
  • Papillomavirus Infections / immunology*
  • Papillomavirus Infections / prevention & control*
  • Papillomavirus Vaccines*
  • Time Factors
  • Viral Vaccines / adverse effects
  • Viral Vaccines / immunology*
  • Viral Vaccines / therapeutic use


  • Antibodies, Viral
  • Papillomavirus Vaccines
  • Viral Vaccines
  • human papillomavirus type 18 L1 VLP vaccine