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BukuPhase I clinical study of a peptide vaccination for hepatitis C virus-infected patients with different human leukocyte antigen-class I-A alleles (from Cancer Science 2009, 100 (10), 1935-1942)
Author: Yutani, Shigeru ; Komatsu, Nobukazu ; Shichijo, Shigeki ; Yoshida, Kazumi ; Takedatsu, Hiroko ; Itou, Minoru ; Kuromatu, Ryoko ; Ide, Tatsuya ; Tanaka, Masatoshi ; Sata, Michio ; Yamada, Akira ; Itoh, Kyogo
Topik: Peptide vaccination; Hepatitis C virus; Human leukocyte antigen; Seminar - Thesis lit
Bahasa: (EN )    
Penerbit: Japanese Cancer Association     Tahun Terbit: 2009    
Jenis: Article - diterbitkan di jurnal ilmiah internasional
Fulltext: j.1349-7006.2009.01256.x.pdf (839.93KB; 0 download)
Hepatitis C virus (HCV) infection has a high risk of liver cirrhosis and hepatocellular carcinoma at later stages. We recently identified a peptide derived from the HCV core protein capable of inducing both cellular and humoral responses to nearly all HCV-positive patients in Japan with different human leukocyte antigen (HLA)-class I-A alleles. To assess the safety and immune responses to this novel peptide, we conducted a phase I dose-escalation study of the vaccination for 26 HCV-positive patients who were either non-responders to the interferon-based therapy (n = 23) or refused it (n = 3). The regimen was well tolerated, with no severe vaccine-related toxicity. Twenty-five and 22 patients completed the first and second cycle vaccination (6 and 12 vaccine injections), respectively. After a series of six vaccine injections, peptide-specific CTL activity was augmented in peripheral blood mononuclear cells from 15 of 25 patient samples, with an expected optimal dose of 1 mg peptide. After 12 vaccine injections, peptide-specific IgG production was augmented in plasma from the majority of patients (15 of 22 patients) tested, but not in a dosedependent fashion. There were two HCV RNA responders with >1 log declines. Among patients whose pre-vaccination levels of alanine aminotransferase and alpha feto-protein exceeded the normal ranges, a <30% decrease was found in 7 of 24 and three of six patients, respectively. Because of its tolerability and higher rate of immune boosting, this protocol is recommended for a phase II study to investigate its clinical efficacy.

[seminar - thesis lit]
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