Central Influenza and Emerging Infectious Diseases Vaccine Immunoassay Laboratory Services

BARDA is seeking to partner with laboratories with existing capabilities to function as a central immunoassay laboratory and perform quality-assured immunoassays to support advanced research and development of influenza and emerging infectious disease vaccines using samples collected from nonclinical studies and clinical trials. Additionally, the central immunoassay laboratory will provide rapid response capability to qualify/validate immune assays for newly emerged viral strains or variants and test clinical and/or nonclinical samples in an accelerated fashion in the event of an influenza virus outbreak. Data from these assays may be used in primary, secondary, and exploratory endpoint analyses for vaccine clinical trials, cross-reactivity testing for pandemic readiness and response purposes or perform correlates of protection analyses.

Award Details

Member Organization: Duke University
Award Date: 12/23/2025
Award Amount: $1,492,307
Project Duration: 45 months

Solicitation Number: RRPV RPP-24-07-CentralIEIDLab

Project Objective: The objective of this project is to serve as BARDA’s centralized, GCLP-compliant immunoassay hub, developing and harmonizing validated immune response assays and reference standards to generate regulatory-grade, comparable immunogenicity data that accelerate vaccine development for influenza and emerging infectious diseases.