SBIR-STTR Award

The goal of this project (Phase I - III) is to develop a vaccine for the control of diseases in Atlantic cod caused by L. anguillarum and A. salmonicida. To accomplish this we have established the following sequential technical Phase I objectives: (1) identify bacterial growth conditions suitable for small-scale vaccine production, (2) determine the conditions for inactivation that result in the retention of immunoprotective properties and abolish infectivity of the bacteria, (3) standardize the content of a single dose of vaccine, (4) formulate the vaccine with or without adjuvant and (5) measure the safety and efficacy of the vaccine in Atlantic cod. The Phase II and III research efforts will include scale-up of vaccine production, determination of optimal vaccine dose, optimal adjuvant and vaccine formulation, duration and kinetics of the protective immune response elicited by the vaccine, vaccine safety and efficacy of the vaccine against heterologous bacteria. SUMMARY OF

Anticipated Results:
The ultimate success of the project will be the construction of a safe, efficacious L. anguillarum and A. salmonicida vaccine for farmed Atlantic cod. Maine BioTek, Inc. anticipated that the Phase I investigation will result in a prototype vaccine. By the end of Phase II, the vaccines will be ready for regulatory approval testing. The product will initially be marketed to the North American aquaculture industry for administration of farmed Atlantic cod. An efficacious L. anguillarum and A. salmonicida vaccine would provide a disease management tool that in combination with good fish health practices would ensure the growth and sustainability of the emerging Atlantic cod aquaculture industry in North America.

This SBIR Phase II project provides the scientific framework for development and ultimately commercialization of a multivalent vaccine for the prevention of disease caused by Listonella anguillarum and Aeromonas salmonicida of cultured Atlantic cod in North America. According to leading cod producers in the region, a multivalent bacterial vaccine is essential to their ability to produce and commercialize farmed cod as well as their ability to attract investment. The multivalent vaccine will have a far reaching positive influence on aquaculture, fisheries, and environmental management in North America, regional seafood markets and trade opportunities, coastal economic development and our supply of wholesome, high quality Atlantic cod. The Phase II work plan addresses five primary topics involved in the multivalent vaccine prototype development: (1) antigen synthesis, (2) vaccine formulation, (3) vaccine safety, (4) vaccine potency and (5) vaccine efficacy. Within this framework, we will optimize antigen production, identify the minimal effective vaccine dose and evaluate different modes of vaccine delivery. The deliverable product will be an efficacious multivalent vaccine prototype that after translational development, manufacturing and regulatory approval will be available to cod producers for the prevention of disease caused by L. anguillarum and A. salmonicida. SUMMARY OF

Anticipated Results:
The ultimate success of the project will be the construction of a safe, efficacious, multivalent L. anguillarum and A. salmonicida vaccine for farmed Atlantic cod. Maine BioTek, Inc. anticipates that the Phase II investigation will result in a prototype vaccine. By the end of Phase II, the vaccine will be ready for regulatory approval testing. The product will initially be marketed to the North American aquaculture industry for administration to farmed Atlantic cod. An efficacious multivalent L. anguillarum and A. salmonicida vaccine would provide a disease management tool that in combination with good fish health practices would ensure the growth and sustainability of the emerging Atlantic cod aquaculture industry in North America.