A single-dose prophylactic Japanese Encephalitis vaccine

Information

  • Research Project
  • 6818316
  • ApplicationId
    6818316
  • Core Project Number
    U01AI061242
  • Full Project Number
    1U01AI061242-01
  • Serial Number
    61242
  • FOA Number
    RFA-AI-03-17
  • Sub Project Id
  • Project Start Date
    6/1/2005 - 19 years ago
  • Project End Date
    5/31/2008 - 16 years ago
  • Program Officer Name
    REPIK, PATRICIA M.
  • Budget Start Date
    6/1/2005 - 19 years ago
  • Budget End Date
    5/31/2006 - 18 years ago
  • Fiscal Year
    2005
  • Support Year
    1
  • Suffix
  • Award Notice Date
    5/27/2005 - 19 years ago
Organizations

A single-dose prophylactic Japanese Encephalitis vaccine

[unreadable] DESCRIPTION (provided by applicant): 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. [unreadable] 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; [unreadable] 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; [unreadable] 3. Complete pre-clinical development including the establishment of safety, stability and pharmacological activity of the vaccine components. [unreadable] 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. [unreadable] [unreadable]

IC Name
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
  • Activity
    U01
  • Administering IC
    AI
  • Application Type
    1
  • Direct Cost Amount
  • Indirect Cost Amount
  • Total Cost
    1914095
  • Sub Project Total Cost
  • ARRA Funded
  • CFDA Code
    856
  • Ed Inst. Type
  • Funding ICs
    NIAID:1914095\
  • Funding Mechanism
  • Study Section
    ZAI1
  • Study Section Name
    Special Emphasis Panel
  • Organization Name
    INTERCELL AG
  • Organization Department
  • Organization DUNS
  • Organization City
    VIENNA
  • Organization State
  • Organization Country
    AUSTRIA
  • Organization Zip Code
    A-1030
  • Organization District
    AUSTRIA