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针对对基于干扰素的治疗无反应的丙型肝炎病毒(HCV)1b感染患者的个性化肽疫苗的I期临床研究。

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.

作者信息

Yutani Shigeru, Yamada Akira, Yoshida Kazumi, Takao Yukari, Tamura Mayumi, Komatsu Nobukazu, Ide Tatsuya, Tanaka Masatoshi, Sata Michio, Itoh Kyogo

机构信息

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

出版信息

Vaccine. 2007 Oct 16;25(42):7429-35. doi: 10.1016/j.vaccine.2007.08.005. Epub 2007 Aug 24.

DOI:10.1016/j.vaccine.2007.08.005
PMID:17845828
Abstract

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.

摘要

为评估针对丙型肝炎病毒(HCV)1b衍生肽的个性化肽疫苗接种的安全性和免疫反应,本研究纳入了12例对基于干扰素的治疗无反应的HCV1b阳性患者。检测了接种前外周血T细胞和血浆IgG对四种能够在HLA-A24(+)患者中诱导细胞毒性T淋巴细胞(CTL)的候选疫苗肽的反应性,然后仅对有反应的肽以三种不同剂量设置每两周给药一次。该研究耐受性良好,无严重毒性。在第7次接种后,观察到针对至少一种接种肽的肽特异性CTL活性和IgG增强。在第14次接种后,分别在5例和3例患者中观察到血清丙氨酸转氨酶和HCV-RNA水平下降。

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