Preclinical evaluation of multi antigenic HCV DNA vaccine for the prevention of Hepatitis C virus infection

Sci Rep. 2017 Mar 7:7:43531. doi: 10.1038/srep43531.

Abstract

Direct-acting antiviral treatment for hepatitis C virus (HCV) infection is costly and does not protect from re-infection. For human and chimpanzees, recovery from acute HCV infection correlates with host CD4+ and CD8+ T cell responses. DNA plasmids targeting the HCV non-structural antigens NS3, NS4, and NS5, were previously reported to induce robust and sustained T cell responses in mice and primates. These plasmids were combined with a plasmid encoding cytokine IL-28B, together named as VGX-6150. The dose-dependent T cell response and safety of VGX-6150 administered intramuscularly and followed by electroporation was assessed in mice. Immune responses plateaued at 20 μg/dose with IL-28B demonstrating significant immunoadjuvant activity. Mice administered VGX-6150 at 40, 400, and 800 μg given either as a single injection or as 14 injections given bi-weekly over 26 weeks showed no vaccine related changes in any clinical parameter compared to placebo recipients. There was no evidence of VGX-6150 accumulation at the injection site or in any organ 1 month following the 14th vaccination. Based on these studies, the approximate lethal dose (ALD) exceeds 800 μg/dose and the NOAEL was 800 μg/dose in mouse. In conclusion, VGX-6150 appears safe and a promising preventive vaccine candidate for HCV infection.

MeSH terms

  • Animals
  • Cytokines / biosynthesis
  • Disease Models, Animal
  • Dose-Response Relationship, Immunologic
  • Female
  • Hepacivirus / genetics*
  • Hepacivirus / immunology*
  • Hepatitis C / immunology*
  • Hepatitis C / prevention & control*
  • Hepatitis C Antigens / genetics
  • Hepatitis C Antigens / immunology*
  • Humans
  • Immunity, Cellular
  • Immunization
  • Immunization Schedule
  • Male
  • Mice
  • Mice, Inbred C57BL
  • T-Lymphocytes / immunology
  • T-Lymphocytes / metabolism
  • Time Factors
  • Tissue Distribution
  • Vaccines, DNA / administration & dosage
  • Vaccines, DNA / adverse effects
  • Vaccines, DNA / immunology*
  • Viral Hepatitis Vaccines / administration & dosage
  • Viral Hepatitis Vaccines / adverse effects
  • Viral Hepatitis Vaccines / genetics
  • Viral Hepatitis Vaccines / immunology*

Substances

  • Cytokines
  • Hepatitis C Antigens
  • Vaccines, DNA
  • Viral Hepatitis Vaccines
  • interferon-lambda protein, mouse