Centivax, Inc.

This Proposal Will Advance CENTI-POULT-H5, a Broadly Protective Vaccine to Protect Poultry From Highly Pathogenic Avian Influenza (hpai). CENTI-POULT-H5 Is Intended to Be a Safe, Potent, and Efficacious Vaccine That Provides Broad Immunity Across Currently Endemic Hpai H5 Variants as Well as Potential Future Variants Without Requiring Reformulation for Emergent Strains. Hpai Continues to Devastate Poultry Flocks, Which Has Caused Severe Economic Losses and Threatens the Security of the U.s. Poultry Industry. Centivax Will Leverage Its Computational Universal Immunity Platform to Advance a Highly-multivalent Vaccine That Incorporates Eight Divergent H5N1 Hemagglutinin Antigens Alongside a T-cell Targeting Construct Containing Conserved Influenza T-cell Epitopes. This Multivalent Design Is Engineered to Induce Broad Protective Immunity Against Diverse H5N1 Strains Through Centivax's Innovative Epitope Focusing Approach. Centivax Has Already Demonstrated Efficacy for This Vaccine Approach for Influenza in Several Species Including Mice, Rats, Pigs, Ferrets, Cattle and Human Immune Organoids. This Project Will Be Executed Over a 2-YEAR, $2M Timeline With Three Objectives 1) Evaluate Scalable Mass-administration Methods of CENTI-POULT-H5 Vaccine in Chickens, Including in Ovo Injection, Aerosol Spray Vaccination, and Drinking Water Administration; 2) Conduct Dose-finding Studies to Determine the Optimal CENTI-POULT-H5 Dose via TH E Selected Mass-administration Method; and 3) Evaluate Protective Efficacy of the Optimized CENTI-POULT-H5 Vaccine Dose in a H5N1 Challenge Study in Chickens. Expected Outcomes Include a Vaccine That Provides Broad Protection Against Diverse Hpai Strains, Potentially Reduces Virus Transmission, and Significantly Improves Current Vaccination Strategies. the Project Will Be Conducted in Collaboration With DR. Daniel Perez at the College of Veterinary Medicine, University of Georgia, an Expert in Avian Influenza Pathogenesis and Poultry Vaccine Development. Success Will Deliver an Optimal Method for Mass Vaccination With CENTI-POULT-H5 in Chickens and Robust Evidence of Its Broad Safety and Efficacy, Where Centivax Will Be Able to Rapidly Deploy CENTI-POULT-H5 Upon Completion of This Project to Improve Hpai Outcomes for the Poultry Industry. Beneficiaries Include the U.s. Poultry Industry, Consumers Facing High Egg and Poultry Prices, and Government Agencies Responsible for Hpai Control. the Vaccine Will Contribute to Usda's Comprehensive Strategy to Curb Hpai, Protect the Poultry Industry and Lower Egg Prices.