DEVELOPMENT OF A SAFE AND EFFECTIVE VACCINE AGAINST WEST NILE VIRUS

这个子项目是许多利用资源的研究子项目之一 由NIH/NCRR资助的中心拨款提供。子项目的主要支持 而子项目的主要调查员可能是由其他来源提供的， 包括其它NIH来源。 列出的子项目总成本可能 代表子项目使用的中心基础设施的估计数量， 而不是由NCRR赠款提供给子项目或子项目工作人员的直接资金。 虽然有一个有效的兽医疫苗对西尼罗河病毒，目前没有FDA批准的疫苗可用于预防人类西尼罗河病毒感染。 在这项提案中，我们将使用一种专有的新平台技术来开发一种灭活疫苗制剂，该制剂可用于免疫不同人群，包括老年人等免疫脆弱群体。 我们的初步研究表明，这种疫苗方法是可行的，高度免疫原性（引发CD 8 + T细胞和中和抗体反应），并保护小鼠免受致命的WNV感染。 在该项目中，我们已开始在小鼠中评价候选疫苗制剂，我们已进行了规模扩大开发，并将于今年晚些时候开始cGMP生产主要候选疫苗。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. Primary support for the subproject and the subproject's principal investigator may have been provided by other sources, including other NIH sources. The Total Cost listed for the subproject likely represents the estimated amount of Center infrastructure utilized by the subproject, not direct funding provided by the NCRR grant to the subproject or subproject staff. Although there is an effective veterinary vaccine against WNV, there are currently no FDA-approved vaccines available for preventing human WNV infection. In this proposal, we will use a proprietary new platform technology for developing an inactivated vaccine formulation that can be used to immunize a diverse population including immunologically vulnerable groups such as the elderly. Our preliminary studies demonstrate that this vaccine approach is feasible, highly immunogenic (eliciting CD8+ T cell and neutralizing antibody responses) and protects mice against lethal WNV infection. In this project, we have begun to evaluate candidate vaccine formulations in mice, we have performed scale-up development, and will begin cGMP manufacturing of the lead candidate vaccine later this year.