Cross-Protective Multivalent Vaccine for Tick-Borne Flaviviruses

Information

  • Research Project
  • 9847913
  • ApplicationId
    9847913
  • Core Project Number
    R44AI118017
  • Full Project Number
    2R44AI118017-03
  • Serial Number
    118017
  • FOA Number
    PA-18-574
  • Sub Project Id
  • Project Start Date
    4/6/2015 - 10 years ago
  • Project End Date
    7/31/2022 - 2 years ago
  • Program Officer Name
    ALARCON, RODOLFO M
  • Budget Start Date
    8/8/2019 - 5 years ago
  • Budget End Date
    7/31/2020 - 4 years ago
  • Fiscal Year
    2019
  • Support Year
    03
  • Suffix
  • Award Notice Date
    8/7/2019 - 5 years ago
Organizations

Cross-Protective Multivalent Vaccine for Tick-Borne Flaviviruses

Project Summary/Abstract The NIH/NIAID 2017 Strategic Plan is specifically directed at promoting research that can provide solutions to mitigate the threat posed by emerging and re-emerging diseases. The tick-borne flavivirus (TBFV) group includes a number of important human pathogens that result in serious neurological or hemorrhagic diseases that are either Category B or C priority pathogens. The TBFVs are considered to be emerging or re-emerging pathogens due to increases in the number of human infections, the expansion of their geographic distribution, and emergence of new viruses. Additionally, the number of different viruses in the TBFV group poses challenges. There are two licensed Tick-borne encephalitis virus (TBEV) vaccines in Europe. These vaccines are based on the European strains of TBEV (TBEV-Eu), and while they provide some level of cross-neutralization, not all of the TBFV are covered. Furthermore, these vaccines are not licensed in the U.S. and are no longer available in Canada. The development of a multivalent vaccine that provides cross-protection against multiple pathogenic TBFVs would be of great value and is in line with the priorities of NIH/NIAID to develop multivalent and cross-protective technologies. We have demonstrated that two combinations of TBFV recombinant envelope subunit proteins (r80E) can provide protection against a diverse range of TBFV in a mouse challenge model. Additionally, passive transfer studies using serum from mice immunized with combinations of the r80E protein confirm the role of antibodies in protection against virus challenge. This Phase IIB application builds upon our initial efforts to develop a multivalent TBFV vaccine that provides broad cross-protection against viruses in this group. The proposed research aims to 1) optimizing the vaccine formulation; 2) produce pilot lots of the antigens; 3) conduct a pre-IND meeting with the FDA; and 4) conduct potency and toxicity testing to establish the suitability and safety of the final TBFV vaccine formulation. With the successful completion of these efforts, we will be positioned to advance a multicomponent TBFV vaccine into a cGMP manufacturing campaign and toward clinical evaluation.

IC Name
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
  • Activity
    R44
  • Administering IC
    AI
  • Application Type
    2
  • Direct Cost Amount
  • Indirect Cost Amount
  • Total Cost
    839920
  • Sub Project Total Cost
  • ARRA Funded
    False
  • CFDA Code
    855
  • Ed Inst. Type
  • Funding ICs
    NIAID:839920\
  • Funding Mechanism
    SBIR-STTR RPGs
  • Study Section
    ZRG1
  • Study Section Name
    Special Emphasis Panel
  • Organization Name
    HAWAII BIOTECH, INC.
  • Organization Department
  • Organization DUNS
    113226823
  • Organization City
    HONOLULU
  • Organization State
    HI
  • Organization Country
    UNITED STATES
  • Organization Zip Code
    968175318
  • Organization District
    UNITED STATES