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针对结直肠癌患者癌胚抗原的质粒 DNA 免疫的 I 期安全性研究。

A Phase I safety study of plasmid DNA immunization targeting carcinoembryonic antigen in colorectal cancer patients.

机构信息

Department of Oncology and Pathology (Radiumhemmet), Cancer Centre Karolinska, Karolinska Institutet, Karolinska University Hospital Solna, S-17176 Stockholm, Sweden.

出版信息

Vaccine. 2011 Sep 9;29(39):6817-22. doi: 10.1016/j.vaccine.2010.12.063. Epub 2010 Dec 30.

DOI:10.1016/j.vaccine.2010.12.063
PMID:21195077
Abstract

A plasmid DNA vaccine, encoding a truncated form of human CEA fused to a T-helper epitope (CEA66 DNA) was delivered three times intradermally at 2 mg or intramuscularly at 8 mg by Biojector® to patients with colorectal cancer. Prior to the first vaccination, all patients received cyclophosphamide (300 mg/m²) intravenously. Granulocyte-macrophage colony-stimulating factor (GM-CSF) was administered subcutaneously with each vaccination. All patients completed the vaccine schedule. There were no grade 3 or 4 adverse events (AE). The most frequently reported AE grades 1 and 2 were injection site reactions, fatigue, headache, arthralgia, chest tightness and myalgia. Vaccination with CEA66 DNA in combination with GM-CSF was well tolerated and no signs of autoimmunity have been detected.

摘要

一种质粒 DNA 疫苗,编码与人 CEA 融合的 T 辅助表位的截断形式(CEA66 DNA),通过 Biojector® 皮内注射三次,每次 2 毫克,或肌肉注射 8 毫克,用于治疗结直肠癌患者。在第一次接种疫苗之前,所有患者均接受静脉注射环磷酰胺(300mg/m²)。每次接种疫苗时均皮下给予粒细胞-巨噬细胞集落刺激因子(GM-CSF)。所有患者均完成了疫苗接种计划。无 3 级或 4 级不良事件(AE)。报告的最常见的 1 级和 2 级不良事件是注射部位反应、疲劳、头痛、关节痛、胸闷和肌痛。CEA66 DNA 与 GM-CSF 联合接种具有良好的耐受性,未发现自身免疫迹象。

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