Development of a Next Generation Anthrax Vaccine, dmPA7909

Information

  • Research Project
  • 7937925
  • ApplicationId
    7937925
  • Core Project Number
    U01AI082224
  • Full Project Number
    5U01AI082224-02
  • Serial Number
    82224
  • FOA Number
    RFA-AI-08-001
  • Sub Project Id
  • Project Start Date
    9/30/2009 - 15 years ago
  • Project End Date
    8/31/2012 - 12 years ago
  • Program Officer Name
    ZOU, LANLING
  • Budget Start Date
    9/1/2010 - 14 years ago
  • Budget End Date
    8/31/2012 - 12 years ago
  • Fiscal Year
    2010
  • Support Year
    2
  • Suffix
  • Award Notice Date
    9/15/2010 - 14 years ago
Organizations

Development of a Next Generation Anthrax Vaccine, dmPA7909

DESCRIPTION (provided by applicant): Emergent BioSolutions Inc. (Emergent) is proposing to advance the development of a novel anthrax vaccine dmPA7909. This next generation vaccine is composed of the double-mutant recombinant Bacillus anthracis protective antigen (dmPA), the aluminum adjuvant Alhydrogel(r) and the immunostimulatory oligodeoxynucleotide compound CPG 7909 (Vaxlmmune(tm)) formulated as a dry powder. To ensure that the dmPA7909 vaccine will be stable even at elevated temperatures, Emergent employed proven stabilizing technologies for each of the components in the vaccine formulation. The dmPA has been genetically engineered to remove two major protease cleavage sites within the molecule, and as a result, its stability is significantly improved. This stable dmPA adsorbed to Alhydrogel has been tested in animal efficacy studies and is currently being used in combination with Alhydrogel in a Phase 1 clinical trial. Alhydrogel (aluminum hydroxide) has a long history of use in vaccines including childhood vaccines and has documented stability at 25 and 37 [unreadable]C. CPG 7909, unlike other CpG oligonucleotides, has all of its phosphate linkages replaced with phosphorothioate bonds, thus decreasing its sensitivity to nucleases, thus rendering it stable. Additionally, the spray-dried powder formulation dramatically enhances vaccine stability even at extreme temperatures for an extended period of time. CPG 7909 has also been extensively tested in the clinic alone, and in combination with other Alhydrogel-adjuvanted recombinant vaccines. The characteristics of dmPA7909 that make it an ideal candidate to meet the nation's needs for a next generation anthrax vaccine are: 1. Rapid immune response following 2-3 doses 2. Long-term stability to facilitate ambient temperature storage in the Strategic National Stockpile 3. Ability to be administered in a national emergency without the need for special storage conditions

IC Name
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
  • Activity
    U01
  • Administering IC
    AI
  • Application Type
    5
  • Direct Cost Amount
  • Indirect Cost Amount
  • Total Cost
    2896688
  • Sub Project Total Cost
  • ARRA Funded
    True
  • CFDA Code
    701
  • Ed Inst. Type
  • Funding ICs
    NIAID:2896688\
  • Funding Mechanism
    Research Projects
  • Study Section
    ZAI1
  • Study Section Name
    Special Emphasis Panel
  • Organization Name
    EMERGENT PRODUCT DEVELOPMENT GAITHERSBUR
  • Organization Department
  • Organization DUNS
    189488554
  • Organization City
    GAITHERSBURG
  • Organization State
    MD
  • Organization Country
    UNITED STATES
  • Organization Zip Code
    208793419
  • Organization District
    UNITED STATES