The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project will be to increase global access to vaccines and reduce mortality associated with infectious diseases. As an example, Rotavirus is a major cause of severe gastroenteritis among young children and lack of vaccination results in 450,000 deaths annually. A thermostable rotavirus vaccine would create cost-savings for vaccine manufacturers, national governments, and non-profit vaccine buyers and enable market access in areas of the world that lack sufficient cold-chain capacity. Successful development of a stable rotavirus vaccine would not only have significant positive impact on global rotavirus immunization efforts, but may also revolutionize the general approach to vaccine delivery and distribution. This Phase I project will advance understanding of silk-vaccine interactions, which is needed to guide formulation development. Furthermore, insight into the immunogenicity of silk fibroin itself, as well as the impact of silk on the immunogenicity of a vaccine antigen, will be gained in these studies. This technology has significant commercial potential in that it can be broadly applied to numerous emerging and existing vaccines in the $24 Billion global market.
The proposed project seeks to leverage the unique properties of silk to meet the global need for robust, thermostable vaccines. Thermal instability is a long-standing problem in vaccine development. Despite efforts to improve stability, current formulation approaches do not allow product storage under ambient conditions. Temperature excursions during shipment and storage are common and result in wastage or administration of suboptimal vaccines. The use of silk fibroin, a low-cost biomaterial, represents a novel approach to vaccine stabilization. The goal of the proposed research is to demonstrate feasibility of the silk-stabilization platform to create a rotavirus formulation that does not require cold storage. In addition to traditional liquid and lyophilized vaccine formats, development of a dissolvable thin film strip for oral delivery will be investigated. The proposed research will identify lead candidate silk-rotavirus formulations with improved thermostability and immunogenicity that is at least equivalent to the existing commercial formulation, while offering critical insight into broader issues of vaccine stabilization with silk.