Randomized-controlled phase II clinical trial of a bacterially expressed recombinant hepatitis E vaccine

Vaccine. 2009 Mar 13;27(12):1869-74. doi: 10.1016/j.vaccine.2008.12.061. Epub 2009 Jan 23.

Abstract

The candidate recombinant hepatitis E vaccine, HEV 239, protect monkeys against infection by hepatitis E virus (HEV). The safety and immunogenicity of the vaccine for humans was assessed in a randomized controlled phase II clinical trial. The study was conducted in an endemic area of southern China and consisted of a dose scheduling, involving 457 adults and a dose escalation component involving 155 high school students. The results showed that the vaccine is safe and immunogenic for humans and suggest that it could prevent new HEV infection.

Publication types

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

MeSH terms

  • Adolescent
  • Adult
  • Antibodies, Viral / analysis
  • China / epidemiology
  • Dose-Response Relationship, Immunologic
  • Endemic Diseases
  • Female
  • Follow-Up Studies
  • Hepatitis E / immunology*
  • Hepatitis E virus / immunology*
  • Humans
  • Immunoglobulin G / biosynthesis
  • Immunoglobulin G / immunology
  • Male
  • Middle Aged
  • Reference Standards
  • Treatment Outcome
  • Vaccines, Synthetic / therapeutic use
  • Viral Vaccines / adverse effects
  • Viral Vaccines / immunology
  • Viral Vaccines / therapeutic use*
  • Young Adult

Substances

  • Antibodies, Viral
  • Immunoglobulin G
  • Vaccines, Synthetic
  • Viral Vaccines