Phase 2 Trial for Venezuelan Equine Encephalitis V3526

Information

  • Research Project
  • 6845524
  • ApplicationId
    6845524
  • Core Project Number
    UC1AI062538
  • Full Project Number
    1UC1AI062538-01
  • Serial Number
    62538
  • FOA Number
    RFA-AI-03-16
  • Sub Project Id
  • Project Start Date
    9/15/2004 - 20 years ago
  • Project End Date
    8/31/2009 - 15 years ago
  • Program Officer Name
    REPIK, PATRICIA M.
  • Budget Start Date
    9/15/2004 - 20 years ago
  • Budget End Date
    8/31/2009 - 15 years ago
  • Fiscal Year
    2004
  • Support Year
    1
  • Suffix
  • Award Notice Date
    9/10/2004 - 20 years ago

Phase 2 Trial for Venezuelan Equine Encephalitis V3526

[unreadable] DESCRIPTION (provided by applicant): DVC is responsible for the advanced development and ultimate licensure of vaccines designed to protect against a range of biological agents. One vaccine is a new live-attenuated virus vaccine, V3526, demonstrated to protect against the effects of infection with Venezuelan Equine Encephalitis (VEE) virus. The viruses causing VEE are antigenically related, mosquito-borne viruses that are members of the Togavirus family, genus Alphavirus. Although outbreaks occur only occasionally, these viruses can spread rapidly through large populations. DVC proposes that once a VEE vaccine becomes widely available, the value of VEE as a biological weapon will be significantly reduced. There are six subtypes of VEE virus (I-VI), with subtype I comprising several varieties (A-F). The subtypes responsible for large equine epizootics are IA/B, and IC. However, enzootic strains of VEE such as IE and IIIA are also known to be highly virulent for man and would constitute equally effective biological warfare agents. V3526 vaccination provides protection against aerosol challenge (multiple subtypes) in murine, equine, and non-human primate models. The V3526 candidate vaccine did not induce any measurable viremia or observable clinical symptoms such as significant fever, diarrhea, inactivity, or anorexia in either equines or non-human primates. The overall objective of the proposed project is the fast-track development of a safe and efficacious vaccine against VEE that will provide maximal immunologic protection against subtypes IA/B, IC, IE, and IIIA. DVC is currently manufacturing a clinical lot of V3526 vaccine for a phase 1 trial to initiate in 2004, funded by the Department of Defense. The manufacturing, lot release and toxicology strategy has been reviewed by the FDA. Two nonclinical lots have been produced and tested extensively in animals. The specific aims of the proposed project are to optimize the production process, including scale-up and lyophilization of V3526 vaccine, to manufacture a clinical lot of V3526 for a phase 2 trial, and to complete a phase 2 clinical trial. [unreadable] [unreadable]

IC Name
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
  • Activity
    UC1
  • Administering IC
    AI
  • Application Type
    1
  • Direct Cost Amount
  • Indirect Cost Amount
  • Total Cost
    9996228
  • Sub Project Total Cost
  • ARRA Funded
  • CFDA Code
    856
  • Ed Inst. Type
  • Funding ICs
    NIAID:9996228\
  • Funding Mechanism
  • Study Section
    ZAI1
  • Study Section Name
    Special Emphasis Panel
  • Organization Name
    DYNPORT VACCINE COMPANY, LLC
  • Organization Department
  • Organization DUNS
    014130053
  • Organization City
    FREDERICK
  • Organization State
    MD
  • Organization Country
    UNITED STATES
  • Organization Zip Code
    21702
  • Organization District
    UNITED STATES