Development And Production Of Filovirus DNA Plasmid Vaccines

丝状病毒DNA质粒疫苗的开发和生产

• 批准号: 8556151
• 负责人: Richard Schwartz
• 金额: $ 216.61万
• 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/8556151
• 关键词: Adenovirus Vector; Bioterrorism; Clinic; Clinical; Clinical Research; Clinical Trials; Contracts; DNA; DNA Vaccines; Development; Disease Outbreaks; Ebola Vaccines; Filovirus; Human; Immune response; Laboratories; Laboratory Study; National Institute of Allergy and Infectious Disease; Phase; Placebos; Plants; Preventive; Production; Regimen; Satellite Viruses; Techniques; Testing; United States National Institutes of Health; Vaccine Production; Vaccine Research; Vaccines; Viral; Virus; clinical material; design; manufacturing process; next generation; preclinical safety; preclinical study; programs; research clinical testing; safety study; vaccine candidate; vaccine development; vector vaccine

This project is designed to prepare a GMP quality investigational filovirus vaccines and complete the preclinical and laboratory studies needed to begin clinical trials. The Vaccine Research Center (VRC), NIAID is developing a vaccine strategies directed at filoviruses such as Marburg and Ebola for which there are no current preventive vaccines and no available therapy. These viruses are associated with sporadic natural outbreaks as well as the potential to be used as bioterrorism attacks. The vaccine candidates are designed to elicit immune responses to viral sequences from viruses isoalted from the most recent outbreaks. In November 2003, the VRC Clinical Trials Core launched a Phase I clinical study (VRC 204) of a multigene DNA Ebola vaccine at the NIH Clinical Center (Bethesda, MD) as the first step in developing these products regimen. The trial completed entollment and a next-generation Ebola DNA vaccine as well as a Marburg DNA vaccine was manufactured and completed nonclinical testing. Clinical evaluation of the Marburg DNA vaccine has begun. These vaccines will be evaluated clinically as single agents and as part of a DNA prime-adenovector boost regimen.

该项目旨在准备GMP质量研究性丝状病毒疫苗，并完成开始临床试验所需的临床前和实验室研究。 NIAID疫苗研究中心（VRC）正在制定针对货物病毒（例如Marburg和Ebola）的疫苗策略，目前没有预防性疫苗，也没有可用的治疗。这些病毒与零星的自然暴发以及用作生物恐怖攻击的潜力有关。候选疫苗旨在从最新暴发中引起对病毒序列的免疫反应。 2003年11月，VRC临床试验核心（VRC临床试验核心）在NIH临床中心（MD Bethesda）进行了I期临床研究（VRC 204），作为开发这些产品方案的第一步。该试验完成了诱因，下一代埃博拉病毒DNA疫苗以及Marburg DNA疫苗的生产并完成了非临床测试。马堡DNA疫苗的临床评估已经开始。这些疫苗将在临床上作为单一药物进行评估，并将作为DNA原始植物增强剂方案的一部分。