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Immunogenicity of CIGB-230, a therapeutic DNA vaccine preparation, in HCV-chronically infected individuals in a Phase I clinical trial
- Source :
- Journal of Viral Hepatitis. 16:156-167
- Publication Year :
- 2009
- Publisher :
- Wiley, 2009.
-
Abstract
- Summary. 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.
- Subjects :
- Adult
Male
Viral Hepatitis Vaccines
Cellular immunity
T-Lymphocytes
Hepatitis C virus
Hepacivirus
Biology
Lymphocyte Activation
medicine.disease_cause
DNA vaccination
Interferon-gamma
Immune system
Antigen
Neutralization Tests
Virology
Vaccines, DNA
medicine
Humans
Hepatology
Viral Core Proteins
Immunogenicity
Hepatitis Antigens
Hepatitis C Antibodies
Hepatitis C, Chronic
Middle Aged
Viral Load
Vaccination
Treatment Outcome
Infectious Diseases
Immunology
RNA, Viral
Female
Immunization
Viral load
Subjects
Details
- ISSN :
- 13652893 and 13520504
- Volume :
- 16
- Database :
- OpenAIRE
- Journal :
- Journal of Viral Hepatitis
- Accession number :
- edsair.doi.dedup.....26396b49f7be86b17f4f6478ba000c91