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.

Autor: Castellanos M; Instituto Nacional de Gastroenterología, Havana City, Cuba., Cinza Z, Dorta Z, Veliz G, Vega H, Lorenzo I, Ojeda S, Dueñas-Carrera S, Alvarez-Lajonchere L, Martínez G, Ferrer E, Limonta M, Linares M, Ruiz O, Acevedo B, Torres D, Márquez G, Herrera L, Arús E
Jazyk: angličtina
Zdroj: The journal of gene medicine [J Gene Med] 2010 Jan; Vol. 12 (1), pp. 107-16.
DOI: 10.1002/jgm.1407
Abstrakt: 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.)
Databáze: MEDLINE
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