Driven by the urgent need to safeguard the US poultry industry from the devastating impact of highly pathogenic avian influenza (HPAI), this project leverages a powerful synergy between the university…

The Department of Agriculture Animal and Plant Health Inspection Service awarded the University of Georgia Research Foundation, Inc. a cooperative agreement totaling $1,999,873 on February 2, 2026, under the Plant and Animal Disease, Pest Control, and Animal Care program (CFDA 10.025).

The award funds development of the first U.S.-approved, mass-vaccination-ready modified live virus (MLV) vaccine against highly pathogenic avian influenza (HPAI) for commercial poultry, specifically layer and turkey operations. The project delivers an H5N2 MLV candidate engineered to achieve high titers (10^6 TCID50/mL), provide protective immune responses against aggressive H5N1 HPAI challenge after a single dose, and generate humoral, mucosal, and cellular immunity. The H5N2 MLV incorporates a chimeric segment and specific molecular markers with unique sequences. Accompanying diagnostics include real-time RT-qPCR and nucleic acid-based serological assays designed to differentiate infected from vaccinated animals (DIVA capability). Deliverables comprise the U.S.-approved vaccine formulation, peer-reviewed publications, regulatory documentation, and diagnostic tool specifications necessary for vaccine and diagnostic approvals.

The project period runs through February 1, 2029, with place of performance in Athens, Georgia. Sub-awardees Ceva Animal Health and Biostone Animal Health contribute expertise in generating the first licensed MLV against avian influenza for poultry use in the U.S. and developing nucleic acid-based and ELISA-based diagnostic tools.

Driven by the urgent need to safeguard the US poultry industry from the devastating impact of highly pathogenic avian influenza (HPAI), this project leverages a powerful synergy between the university of georgia's cutting-edge research capabilities and the established industrial expertise of ceva animal health and biostone animal health to deliver a transformative solution: the first US-approved, mass-vaccination-ready modified live virus (MLV) vaccine against HPAI, accompanied by a comprehensive suite of companion DIVA diagnostics. This involves generating an H5N2 MLV candidate that is stable, grows to high titers (≥10^6 TCID50/ML), and elicits protective immune responses against aggressive H5N1 HPAI challenge after a single dose. The H5N2 MLV will be designed with a chimeric segment and incorporate specific molecular markers with unique sequences. Molecular diagnostic tools, including real-time RT-qpcr and NA-based serological assays, will also be developed to differentiate infected from vaccinated animals (DIVA). Key deliverables include a US-approved, mass-vaccination-ready influenza MLV against HPAI, along with reports, peer-reviewed publications, and other documentation necessary for vaccine and diagnostic tool approvals. The expected outcome is a reduction in the impact of HPAI virus pathogenesis and transmission in commercial poultry premises, specifically layer and turkey operations. The successful vaccine will stimulate humoral, mucosal, and cellular immunity, offering more effective protection against diverse HPAI strains. This project will positively impact the broader US poultry industry by providing a valuable tool for controlling and preventing HPAI outbreaks. Sub-awardees, including ceva animal health and biostone animal health, play crucial roles. Ceva will contribute their expertise in generating the first licensed MLV against avian influenza for poultry use in the US. Ceva and BIO- stone will also develop nucleic acid-based and elisa-based diagnostic assays, respectively, providing an all-in-one vaccine and differential diagnostics platform.