CAMBRIDGE TECHNOLOGIES LLC — Department of Agriculture SBIR Phase II: 8.3

Description

Vaccination has been the most effective means of controlling influenza infections of pigs. Howeverprotective antibody responses are largely strain-specific and are not effective against different influenzaviruses. Therefore the development of a vaccine candidate that elicits broad-spectrum protection againstdiverse influenza A viruses (IAV) i.e. a universal swine influenza vaccine is critically needed.WithUSDA SBIR phase I support we have successfully developed a novel recombinant swine influenzabivalent neuraminidase subunit vaccine expressed in baculovirus designated BacNA1/BacNA2 whichprotects pigs from infections of multiple swine influenza A subtypes.The goal of our phase II projectis to further develop our BacNA1/BacNA2 vaccine and obtain USDA licensure as an intramuscularvaccine to prevent respiratory disease caused by IAV in pigs.This will be achieved through thefollowing five objectives: 1) to develop an in vitro potency assay to quantify NA protein in theBacNA1/BacNA2 vaccine; 2) to optimize scale up and production processes for vaccine production; 3)to determine optimal baculovirus inactivation procedures; 4) to determine duration of immunity; and 5)to evaluate maternal antibody interference. Successful completion of these objectives will allow usdevelop a commercial scale production process that enables economical production of the vaccine aswell as generate safety and efficacy data to meet USDA licensure requirements. This work will beperformed through close collaboration between Cambridge Technologies and South Dakota StateUniversity to leverage our productive collaboration and expertise from both academia and industry invaccine development swine influenza and commercial vaccine production.