DEVELOPMENT OF A SAFE AND EFFECTIVE VACCINE AGAINST WEST NILE VIRUS

这个子项目是利用资源的许多研究子项目之一。 由NIH/NCRR资助的中心拨款提供。对子项目的主要支持 子项目的首席调查员可能是由其他来源提供的， 包括美国国立卫生研究院的其他来源。为子项目列出的总成本可能 表示该子项目使用的中心基础设施的估计数量， 不是由NCRR赠款提供给次级项目或次级项目工作人员的直接资金。 虽然有一种有效的针对西尼罗河病毒的兽医疫苗，但目前还没有FDA批准的疫苗来预防人类感染西尼罗河病毒。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配方，该配方可用于为包括老年人等免疫脆弱群体在内的不同人群接种疫苗。我们的初步研究表明，这种疫苗方法是可行的，具有高度的免疫原性(激发CD8T细胞和中和抗体反应)，并保护小鼠免受致死性WNV感染。在这个项目中，我们已经开始在小鼠身上评估候选疫苗配方，我们已经进行了扩大开发，并将于今年晚些时候开始生产主要候选疫苗的cGMP。

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.