Plant Produced Porcine IL-12 Vaccine Adjuvant for Swine Flu and Other Viral Diseases

As the nation attempts to meet the challenges posed by the spread of pandemic influenza there is a need for innovative strategies to produce effective vaccines for humans, poultry and livestock. Interleukin-12 (IL-12) is a potent adjuvant of cell-mediated immunity that has been shown to enhance protection afforded by influenza vaccines. The use of IL-12 adjuvant could improve vaccines for several serious porcine diseases including flu but the high cost of current production methods does not sustain the scaled up product availability necessary for large scale vaccination strategies. Plant-based production offers several potential benefits over conventional production systems including lower startup costs and increased flexibility in terms of scale-up, storage, safety, and cost containment. We have demonstrated that plants can produce fully functional mouse and chicken IL-12 at production levels compatible with large scale commercial applications. This Phase I SBIR proposes to show the feasibility of plant-based bio-production of porcine IL-12 (PoIL-12) by addressing the following specific aims: I. Construct porcine IL-12 gene vectors for expression in plants. II. Test IL-12 gene vectors for protein yield and bioactivity in a tobacco transient expression system. This Phase I feasibility study will establish the ability of plants to produce bioactive porcine IL-12, provide productivity assessments, and establish bio-production protocols for supplying bioactive PoIL-12 to researchers for further R&D. Phase II research will address development of stable transgenic plant lines, IL-12 product characterization and purification, scaled up production, and demonstrations of adjuvancy and protection against flu in porcine vaccine trials.