Office of Biomedical Advanced Research and Development Authority Broad Agency Announcement (BAA)

The overall objective of this contract is that the Contractor will function as the USG’s centralized assay laboratory for immune assay development and high throughput testing for sera and mucosal samples for primary, secondary, exploratory endpoints and/or post-hoc analyses for vaccine clinical studies. Specifically, the data gathered from the clinical study samples testing will be used in primary, secondary, exploratory endpoint and/or post-hoc analyses for vaccine clinical studies. Data may be used to support U.S. FDA EUA or BLA, or other regulatory agency submissions, as well as monitoring their subsequent efficacy against newly emerging variant viruses. The scope of work includes providing development and testing services to the USG for immune assays. These immune assays shall include development of qualified (and if needed) validated pseudotyped virus neutralization (PsVN), IgG and IgA binding MSDECL assays, ACE2-receptor blocking assays for sera and mucosal samples. Additionally, PPD will perform high throughput testing of human serum and mucosal samples using the above-mentioned assays in compliance with Good Clinical Laboratory Practices (GCLP). The Contractor's success in completing the required tasks under the work segments must be demonstrated through the Deliverables and Milestones specified under Article F of this contract.