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Task V15: Development of Assays and Reagents for mpox Vaccines

  • Funded by National Institutes of Health (NIH)
  • Total publications:0 publications

Grant number: 272201800013I-P00002-759302200004-2

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Key facts

  • Disease

    mpox, Disease X

  • Start & end year

    2022
    2024

  • Known Financial Commitments (USD)

    $632,480

  • Funder

    National Institutes of Health (NIH)

  • Principal Investigator

    THOMAS RUDGE

  • Research Location

    United States of America

  • Lead Research Institution

    BATTELLE CENTERS/PUB HLTH RES & EVALUATN

  • Research Priority Alignment

    N/A

  • Research Category

    Pathogen: natural history, transmission and diagnostics

  • Research Subcategory

    Diagnostics

  • Special Interest Tags

    N/A

  • Study Type

    Non-Clinical

  • Clinical Trial Details

    N/A

  • Broad Policy Alignment

    Pending

  • Age Group

    Not Applicable

  • Vulnerable Population

    Not applicable

  • Occupations of Interest

    Not applicable

  • Mpox Research Priorities

    Vaccines research, development and implementation

  • Mpox Research Sub Priorities

    Development of equitable, accessible, safe and effective vaccines

Abstract

The Evaluation and Testing Services (ETS) for Vaccines and Other Biologics for Infectious Diseases contract provides a variety of product development services from early feasibility studies through activities required for the submission of Biologic License Application (BLA) and/or Investigational New Drug (IND) applications. Task areas include: 1) administrative management and technical support including training and workshops, and quality oversight and management (site visits, critical stage audits, and final study report audits), 2) development, qualification and validation of immune assays, 3) immunogenicity and efficacy testing, 4) non-clinical and clinical sample testing, and 5) safety/toxicology studies. These services will facilitate the development and introduction of new vaccine candidates and biologics (regulated by CBER) against potential agents of bioterrorism and emerging and re-emerging infectious diseases.