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Vaccine. 2007 Oct 16;25(42):7429-35. Epub 2007 Aug 24.

Phase I clinical study of a personalized peptide vaccination for patients infected with hepatitis C virus (HCV) 1b who failed to respond to interferon-based therapy.

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Department of Immunology, Kurume University School of Medicine, Japan.


To assess the safety and immune responses to a personalized peptide vaccination of hepatitis C virus (HCV) 1b-derived peptides, 12 HCV1b-positive patients, who were unresponsive to interferon-based therapy, were enrolled in this study. The reactivity of the pre-vaccination peripheral blood T cells and plasma IgG to four vaccine candidate peptides capable of inducing cytotoxic T lymphocytes (CTLs) in HLA-A24(+) patients was examined and only the reactive peptides were then administered bi-weekly at three different dose settings. The study was well tolerated with no severe toxicity. Augmentation of peptide-specific CTL activity and IgG in response to at least one of the vaccinated peptides was observed after the 7th vaccination. Decrease of serum alanine aminotransferase and HCV-RNA levels after the 14th vaccination was also observed in five and three patients, respectively.

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