Immunization with a DNA vaccine candidate in chronic hepatitis C patients is safe, well tolerated and does not impair immune response induction after anti-hepatitis B vaccination

✍ Scribed by Marlen Castellanos; Zurina Cinza; Zaily Dorta; Gloria Veliz; Héctor Vega; Irma Lorenzo; Sergio Ojeda; Santiago Dueñas-Carrera; Liz Alvarez-Lajonchere; Gillian Martínez; Elena Ferrer; Miladys Limonta; Marbelis Linares; Odalis Ruiz; Boris Acevedo; Dinorah Torres; Gabriel Márquez; Luis Herrera; Enrique Arús

• Publisher: John Wiley and Sons
• Year: 2010
• Tongue: English
• Weight: 142 KB
• Volume: 12
• Category: Article
• ISSN: 1099-498X
• DOI: 10.1002/jgm.1407

✦ Synopsis

Abstract

Background

In the present study, we evaluated the safety of CIGB‐230, a novel vaccine candidate based on the mixture of a plasmid for DNA immunization, expressing hepatitis C virus (HCV) structural antigens, with a recombinant HCV Core protein.

Methods

Fifteen HCV chronically‐infected volunteers with detectable levels of HCV RNA genotype 1b, who were nonresponders to previous treatment with interferon plus ribavirin, were intramuscularly injected with CIGB‐230 on weeks 0, 4, 8, 12, 16 and 20. Individuals were also immunized at weeks 28, 32 and 36 with a recombinant vaccine against hepatitis B. Adverse events were recorded and analyzed. Blood samples were taken every 4 weeks up to month 12 for hematological, biochemical, virological and immunological analysis.

Results

All patients completed the treatment with CIGB‐230. Adverse events were only slight (83.6%) or moderate (16.4%). No significant differences in hematological and biochemical parameters, including serum aminotransferases, were detected between the baseline and post‐treatment state. Induction of a CD4+ T lymphocyte response against a particular region in HCV E1, spanning amino acids 230–312 in HCV polyprotein, was detected in 42.8% of patients during treatment with CIGB‐230. The ability of T cells to proliferate in response to mitogenic stimulation was not weakened. Most individuals (78.6%) were seroprotected after anti‐hepatitis B vaccination and 42.8% were hyper‐responders (antibody titers > 100 UI/ml). No anti‐mitochondrial, anti‐nuclear and anti‐extractable nuclear antigen antibodies were generated during immunization with CIGB‐230.

Conclusions

Vaccination with CIGB‐230 in HCV chronically‐infected individuals was safe, well tolerated and did not impair the ability to respond to non‐HCV antigens. Copyright © 2009 John Wiley & Sons, Ltd.