| The development of vaccines has proved to be one of the most significant medical advances, which has saved many lives by preventing disease such as diphtheria, smallpox, polio, pertussis, tetanus, measles, mumps and rubella. The need to develop new vaccines is a high priority for scientist and governmental agencies due to the increase of newly emerging and reemerging infectious diseases. Additionally, the increased demand for vaccines requires improved and cost effective manufacturing, transportation and delivery methods for the global community.;In the past two decades, there has been a substantial body of research on expression of heterologous proteins in plants as a means to create platforms for novel vaccines that can meet these global needs. Our laboratory is investigating a soybean-seed based platform for production and delivery of immunomodulatory proteins. The resultant products will be formulated for use as oral vaccines and immunotherapy. These studies encompass the steps required in the development of expression cassettes for transformation, followed by the screening process of transgenic events.;Also included in these present studies, we address some of the practical issues regarding the use of soybean seed-based platform expressing a subunit protein for vaccine delivery system. Using the model antigen FanC, we show that seed storage for over four years, processing methods and shipment in the absence of cold chain requirements do not affect the stability and immunogenicity of FanC. We also investigated the safety of soybean seed-based platform by orally administered adjuvanted soy protein formulations to mice. We show that in the presence of a strong humoral immune response to the adjuvant, there is no immune response to coadministered soy proteins. Taken together, these investigations, for the first time, answer some of the practical questions on the use of a transgenic soybean platform for the oral delivery of antigens against infectious diseases. |
