Immunogenicity of CIGB-230, a therapeutic DNA vaccine preparation, in HCV-chronically infected individuals in a Phase I clinical trial

J Viral Hepat. 2009 Mar;16(3):156-67. doi: 10.1111/j.1365-2893.2008.01058.x. Epub 2008 Oct 31.


Hepatitis C virus (HCV) is a worldwide health problem. No vaccine is available against this pathogen and therapeutic treatments currently in use are of limited efficacy. In the present study, the immunogenicity of the therapeutic vaccine candidate CIGB-230, based on the mixture of pIDKE2, a plasmid expressing HCV structural antigens, with a recombinant HCV core protein, Co.120, was evaluated. CIGB-230 was administered by intramuscular injection on weeks 0, 4, 8, 12, 16 and 20 to 15 HCV-chronically infected individuals, non-responders to previous treatment with interferon (IFN) plus ribavirin. Interestingly, following the final immunization, neutralizing antibody responses against heterologous viral pseudoparticles were modified in eight individuals, including six de novo responders. In addition, 73% of vaccinees exhibited specific T cell proliferative response and T cell IFN-gamma secretory response 24 weeks after primary immunization with CIGB-230. Furthermore, 33.3% of individuals developed de novo cellular immune response against HCV core and the number of patients (46.7% at the end of treatment) with cellular immune response against more than one HCV structural antigen increased during vaccination (P = 0.046). In addition, despite persistent detection of HCV RNA, more than 40% percent of vaccinated individuals improved or stabilized liver histology, particularly reducing fibrosis, which correlated with cellular immune response against more than one HCV antigen (P = 0.0053). In conclusion, CIGB-230 is a promising candidate for effective therapeutic interventions based on its ability for enhancing the immune response in HCV chronically infected individuals.

Publication types

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

MeSH terms

  • Adult
  • Female
  • Hepacivirus / genetics
  • Hepacivirus / immunology*
  • Hepacivirus / isolation & purification
  • Hepatitis Antigens / genetics
  • Hepatitis Antigens / immunology
  • Hepatitis C Antibodies / blood*
  • Hepatitis C, Chronic / immunology*
  • Hepatitis C, Chronic / prevention & control
  • Hepatitis C, Chronic / virology
  • Humans
  • Immunization
  • Interferon-gamma / biosynthesis
  • Lymphocyte Activation
  • Male
  • Middle Aged
  • Neutralization Tests
  • RNA, Viral / blood
  • T-Lymphocytes / immunology*
  • Treatment Outcome
  • Vaccines, DNA / administration & dosage
  • Vaccines, DNA / immunology*
  • Vaccines, DNA / therapeutic use
  • Viral Core Proteins / genetics
  • Viral Core Proteins / immunology
  • Viral Hepatitis Vaccines / administration & dosage
  • Viral Hepatitis Vaccines / immunology*
  • Viral Hepatitis Vaccines / therapeutic use
  • Viral Load


  • CIGB-230 vaccine
  • Hepatitis Antigens
  • Hepatitis C Antibodies
  • RNA, Viral
  • Vaccines, DNA
  • Viral Core Proteins
  • Viral Hepatitis Vaccines
  • Interferon-gamma