Task V20: Hamster Sarbecovirus Challenge Model for SARS-CoV-2 Vaccine Testing
- Funded by National Institutes of Health (NIH)
- Total publications:0 publications
Grant number: 272201800013I-0-759302400001-1
Grant search
Key facts
Disease
COVID-19, OtherStart & end year
20242026Known Financial Commitments (USD)
$2,365,162Funder
National Institutes of Health (NIH)Principal Investigator
THOMAS RUDGEResearch Location
United States of AmericaLead Research Institution
BATTELLE CENTERS/PUB HLTH RES & EVALUATNResearch Priority Alignment
N/A
Research Category
Vaccines research, development and implementation
Research Subcategory
Pre-clinical studies
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
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.