Intercell owns exclusive rights to promising vaccine and vaccine adjuvant technologies that the company can employ under this grant application to develop a single dose, prophylactic vaccine for Japanese encephalitis virus (JEV). JEV has been classified as a """"""""Category B Priority Pathogen for Biodefense."""""""" According to the NIAID Biodefense Research Agenda, the current production capacity for the sole licensed JEV vaccine is inadequate in the event of a bioterrorist threat. Additionally, there are no drug treatments for this disease or are there effective environmental controls of transmission. Widespread vaccination is, therefore, considered the only logical control measure. Intercell is not aware of any other company or institution in the USA that has similar promising technology to achieve this important goal. A secondary benefit of this grant is to provide proof for the utility of Intercell's proprietary vaccine adjuvant for use with other antigens, including other NIAID Category A, B, C priority pathogens. The hypothesis is that Intercell can develop a safe and effective JEV vaccine requiring only a single injection of Intercell's unique JE-PIV vaccine in a formulation with Intercell's proprietary adjuvant, IC31. A safe, efficacious, single-injection JEV prophylactic vaccine for use in a Phase 1 clinical trial in three years will be developed according to the following specific aims. ? 1. Develop and validate the assays and vaccine formulations needed to support a pre-clinical effort consistent with FDA requirements for review by the FDA in the Pre-IND format; ? 2. Individually manufacture, release and formulate the JE-PIV vaccine and the IC31 adjuvant for use in pre-clinical development and for a Phase 1 clinical trial; ? 3. Complete pre-clinical development including the establishment of safety, stability and pharmacological activity of the vaccine components. ? The program goal is to rapidly develop this single-injection vaccine in a two-vial vaccine formulation, (separate vials for the IC31 adjuvant and the JE-PIV vaccine, mixed immediately before use), with all of the regulatory documentation needed to critically evaluate the safety and immunogenicity of this improved vaccine format in a Phase I clinical trial. ? ?
