In:
The Journal of Gene Medicine, Wiley, Vol. 12, No. 1 ( 2010-01), p. 107-116
Abstract:
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.
Type of Medium:
Online Resource
ISSN:
1099-498X
,
1521-2254
Language:
English
Publisher:
Wiley
Publication Date:
2010
detail.hit.zdb_id:
2002203-7
SSG:
12
Bookmarklink