以聚乙烯亚胺复合物形式给药的独特型DNA疫苗用于B细胞淋巴瘤患者的I期临床试验。
Phase I clinical trial of idiotypic DNA vaccine administered as a complex with polyethylenimine to patients with B-cell lymphoma.
作者信息
Meleshko A N, Petrovskaya N A, Savelyeva N, Vashkevich K P, Doronina S N, Sachivko N V
机构信息
a Belarusian Research Center for Pediatric Oncology, Hematology and Immunology , Minsk , Belarus.
b N.N. Alexandrov National Cancer Centre of Belarus , Minsk , Belarus.
出版信息
Hum Vaccin Immunother. 2017 Jun 3;13(6):1-6. doi: 10.1080/21645515.2017.1285477. Epub 2017 Mar 8.
Abstract
We report on the design of a phase I, non-randomized, open-label study of idiotypic DNA vaccination in patients with B-cell non-Hodgkin's lymphoma (ISRCTN31090206). The study uses DNA fusion gene vaccination encoding patient-specific single chain variable fragment, or idiotype, linked to an immunostimulatory sequence. Two types of immunostimulatory sequence are being explored: potato virus X coat protein and human chemokine MIP3α. Linear polyethylenimine with low molecular weight (8 kDa) is used as a synthetic vehicle for vaccine delivery. Humoral and T-cellular immune responses to vaccination will be measured by ELISA and ELISPOT, respectively. The primary study endpoints are safety, tolerability and immunogenicity of DNA-PEI vaccination.
摘要
我们报告了一项针对B细胞非霍奇金淋巴瘤患者进行独特型DNA疫苗接种的I期非随机开放标签研究的设计（国际标准随机对照试验编号：ISRCTN31090206）。该研究采用编码患者特异性单链可变片段或独特型的DNA融合基因疫苗接种，并与免疫刺激序列相连。目前正在探索两种免疫刺激序列：马铃薯X病毒外壳蛋白和人趋化因子MIP3α。低分子量（8 kDa）的线性聚乙烯亚胺用作疫苗递送的合成载体。将分别通过酶联免疫吸附测定（ELISA）和酶联免疫斑点法（ELISPOT）检测接种疫苗后的体液免疫和T细胞免疫反应。主要研究终点是DNA-聚乙烯亚胺疫苗接种的安全性、耐受性和免疫原性。
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