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首页> 外文期刊>Vaccine >A phase 1, randomized, controlled dose-escalation study of EP-1300 polyepitope DNA vaccine against Plasmodium falciparum malaria administered via electroporation
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A phase 1, randomized, controlled dose-escalation study of EP-1300 polyepitope DNA vaccine against Plasmodium falciparum malaria administered via electroporation

机译：针对通过电穿孔施用的恶性疟原虫疟疾的EP-1300多表位DNA疫苗的1期随机对照，剂量递增研究

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Plasmodium falciparum malaria is one of the leading infectious causes of childhood mortality in Africa. EP-1300 is a polyepitope plasmid DNA vaccine expressing 38 cytotoxic T cell epitopes and 16 helper T cell epitopes derived from P. falciparum antigens expressed predominantly in the liver phase of the parasite's life cycle. We performed a phase 1 randomized, placebo-controlled, dose escalation clinical trial of the EP-1300 DNA vaccine administered via electroporation using the TriGrid Delivery System device (Ichor Medical Systems). Although the delivery of the EP-1300 DNA vaccine via electroporation was safe, tolerability was less than that usually observed with standard needle and syringe intramuscular administration. This was primarily due to acute local discomfort at the administration site during electroporation. Despite the use of electroporation, the vaccine was poorly immunogenic. The reasons for the poor immunogenicity of this polyepitope DNA vaccine remain uncertain. Clinical Trials Registration: ClinicalTrials.gov NCT01169077. (C) 2016 Elsevier Ltd. All rights reserved.
机译：恶性疟原虫疟疾是非洲儿童死亡的主要传染原因之一。 EP-1300是一种多表位质粒DNA疫苗，表达38种细胞毒性T细胞表位和16种来源于恶性疟原虫抗原的辅助T细胞表位，主要在寄生虫生命周期的肝期表达。我们使用TriGrid Delivery System设备（Ichor Medical Systems）通过电穿孔进行的EP-1300 DNA疫苗的1期随机，安慰剂对照，剂量递增临床试验。尽管通过电穿孔递送EP-1300 DNA疫苗是安全的，但耐受性却比标准的针头和注射器肌肉注射通常观察到的耐受性要低。这主要是由于电穿孔期间给药部位的急性局部不适。尽管使用了电穿孔，但疫苗的免疫原性很差。这种多表位DNA疫苗的免疫原性差的原因仍然不确定。临床试验注册：ClinicalTrials.gov NCT01169077。 （C）2016 Elsevier Ltd.保留所有权利。

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