A Phase I Clinical Trial to Evaluate a Multiple Strain E

评估多种 E 株的 I 期临床试验

• 批准号: 6822481
• 负责人: Barney Scott Graham
• 金额: --
• 依托单位: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/6822481
• 关键词: Adenoviridae; Ebola virus; T lymphocyte; antigen antibody reaction; bioterrorism /chemical warfare; clinical trial phase I; dosage; drug screening /evaluation; hemorrhagic fever; human subject; medical outreach /case finding; patient oriented research; recombinant virus; vaccine evaluation; vector vaccine; viral vaccines

The work on this project was directed towards the development of a phase I, randomized, placebo-controlled, dose-escalation study of an Ebola DNA plasmid vaccine. The hypothesis is that the vaccine will be safe for human administration and elicit immune responses to Ebola. The proposed protocol design is to enroll subjects who will be randomly assigned to DNA vaccine or PBS control injections. If there are no significant toxicities, dose escalation will be initiated. Studies in small animals and non-human primates have shown that regimens of DNA priming followed by administration of viral vectors have demonstrated enhanced immune responses compared to vaccines using DNA alone. Recombinant, replication-deficient adenovirus expressing Ebola genes will be developed and GMP lots produced to further evaluate this vaccination strategy and advance to clinical trials.

该项目的工作是针对I期，随机，安慰剂对照的，剂量降低的研究，对埃博拉菌DNA质粒疫苗的研究。假设是，该疫苗对人类行政管理安全，并引起对埃博拉病毒的免疫反应。提出的协议设计是招募将随机分配给DNA疫苗或PBS控制注射的受试者。如果没有明显的毒性，将开始剂量升级。对小动物和非人类灵长类动物的研究表明，与单独使用DNA相比，与疫苗相比，DNA启动方案随后进行了病毒载体的治疗方案。将开发重组，重组缺陷型腺病毒表达埃博拉病毒基因，并生产GMP批次，以进一步评估这种疫苗接种策略并促进临床试验。