Recombinant Subunit West Nile Virus Vaccine Development

重组亚基西尼罗病毒疫苗开发

• 批准号: 6818284
• 负责人: Raymond Allen Koski
• 金额: $ 95.08万
• 依托单位: L2 DIAGNOSTICS, LLC
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-01 至 2007-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6818284
• 关键词: West Nile virus; antigen antibody reaction; biotechnology; disease /disorder prevention /control; drug adverse effect; enzyme linked immunosorbent assay; hamsters; horses; immunologic assay /test; laboratory mouse; laboratory rabbit; neutralizing antibody; nonhuman therapy evaluation; polymerase chain reaction; recombinant proteins; tissue /cell culture; vaccine development; vaccine evaluation; viral vaccines; virus envelope; virus protein

DESCRIPTION (provided by applicant): The overall goal of this project is to develop a manufacturing process for a recombinant WN (WN) virus subunit vaccine to prevent life-threatening WN virus infections. WN virus was isolated for the first time in North America in 1999. In less than three years, the geographical distribution of the virus expanded dramatically in the United States. A vaccine will be an important complement to other public health measures as this emerging pathogen becomes endemic in this continent. Prior work established a laboratory process for producing a recombinant WN virus envelope protein subunit vaccine. The candidate vaccine induces virus-neutralizing antibodies in mice, rabbits and horses that protect against infection in a murine model of WN virus infection. The proposed preclinical research and development activities will produce the candidate vaccine under Good Manufacturing Practice (cGMP) and Good Laboratory Practice (GLP). The objective is to produce vaccine suitable for Phase I clinical trials. Specific aims include process development, formulation with adjuvant, evaluation of safety, immunogenicity and efficacy in animal models, and preparation of an Investigational New Drug Application. This project will provide clinicians and public health officials with new means to manage WN virus outbreaks.

描述（由申请人提供）：该项目的总体目标是开发重组 WN（WN）病毒亚单位疫苗的生产工艺，以预防危及生命的 WN 病毒感染。 WN病毒于1999年在北美首次分离出来。不到三年的时间，该病毒的地理分布在美国急剧扩大。随着这种新出现的病原体在非洲大陆流行，疫苗将成为其他公共卫生措施的重要补充。先前的工作建立了生产重组 WN 病毒包膜蛋白亚单位疫苗的实验室流程。该候选疫苗可在小鼠、兔子和马体内诱导病毒中和抗体，从而在 WN 病毒感染的小鼠模型中防止感染。拟议的临床前研究和开发活动将根据良好生产规范（cGMP）和良好实验室规范（GLP）生产候选疫苗。目标是生产适合一期临床试验的疫苗。具体目标包括工艺开发、佐剂配方、动物模型中的安全性、免疫原性和功效评估，以及研究性新药申请的准备。该项目将为临床医生和公共卫生官员提供管理 WN 病毒爆发的新方法。