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.
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.
Yutani
Shigeru
S
Department of Immunology, Kurume University School of Medicine, Japan.
Yamada
Akira
A
Yoshida
Kazumi
K
Takao
Yukari
Y
Tamura
Mayumi
M
Komatsu
Nobukazu
N
Ide
Tatsuya
T
Tanaka
Masatoshi
M
Sata
Michio
M
Itoh
Kyogo
K
D000328:Adult; D000368:Aged; D005260:Female; D016174:Hepacivirus / Q000276:immunology*; D018937:Hepatitis C Antibodies / Q000097:blood; D018936:Hepatitis C Antigens; D019698:Hepatitis C, Chronic / Q000276:immunology / Q000628:therapy*; D006801:Humans; D007111:Immunity, Cellular; D007074:Immunoglobulin G / Q000097:blood; D007372:Interferons / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D022223:Vaccines, Subunit / Q000276:immunology / Q000627:therapeutic use; D014761:Viral Hepatitis Vaccines / Q000276:immunology / Q000627:therapeutic use*
D018937:Hepatitis C Antibodies; D018936:Hepatitis C Antigens; D007074:Immunoglobulin G; D022223:Vaccines, Subunit; D014761:Viral Hepatitis Vaccines; D007372:Interferons