Early assessment of the efficacy of a human papillomavirus type 16 L1 virus-like particle vaccine

Vaccine. 2004 Jul 29;22(21-22):2936-42. doi: 10.1016/j.vaccine.2003.11.059.

Abstract

A post hoc analysis was performed using combined data from two Phase I tolerability/immunogenicity studies of monovalent human papillomavirus type 11 (HPV11) or HPV16 L1 virus-like particle (VLP) vaccines. The goal was to determine if the HPV16 L1 VLP vaccine protected against HPV16 infection. Vaccine or placebo was given at 0, 2 and 6 months. HPV16 infection was defined by positive polymerase chain reaction (PCR) results following vaccination. The incidence of HPV infection was observed to be 0 cases per 100 person-years at risk in the vaccine group, and 5 cases per 100 person-years at risk in the control group. These results support the institution of larger efficacy trials for HPV L1 VLP vaccines.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Antibodies, Viral / analysis
  • Antibodies, Viral / biosynthesis
  • DNA Primers
  • Dose-Response Relationship, Immunologic
  • Endpoint Determination
  • Female
  • Follow-Up Studies
  • Humans
  • Papillomaviridae / immunology*
  • Papillomavirus Infections / immunology
  • Papillomavirus Infections / prevention & control*
  • Papillomavirus Vaccines*
  • Radioimmunoassay
  • Reverse Transcriptase Polymerase Chain Reaction
  • Specimen Handling
  • Time Factors
  • Vaccines, DNA / adverse effects
  • Vaccines, DNA / immunology
  • Viral Vaccines / adverse effects
  • Viral Vaccines / immunology*

Substances

  • Antibodies, Viral
  • DNA Primers
  • Papillomavirus Vaccines
  • Vaccines, DNA
  • Viral Vaccines