SBIR Phase II: A New Approach to Developing a Heat-stable Rotavirus Vaccine

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II 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 II project will advance towards commercialization a novel platform technology that both stabilizes vaccines and enables novel delivery formats. 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 advance the silk-stabilization platform towards commercialization of vaccines that do not require cold storage. Building upon successful Phase I results, advanced formulation optimization studies will define a final product formulation for rotavirus that is compatible with scaled manufacturing and achieves all storage and in vivo attributes necessary for a commercial product. Through process optimization studies, fabrication of a dissolvable thin strip for oral delivery of rotavirus will be translated into a scalable manufacturing process that provides an attractive alternative to traditional drying methods. Evaluation of stabilized rotavirus vaccine films in an improved animal model will enable validation of in vivo immunogenicity and offer insight into vaccine stabilization and oral film delivery more broadly.