Development of a Silk-Stabilized Inactivated Polio Vaccine

DESCRIPTION provided by applicant This application entitled andquot Development of a Silk Stabilized Inactivated Polio Vaccineandquot is a response to the Omnibus solicitation of the National Institutes of Health Centers for Disease Control and Prevention Food and Drug Administration and Administration for Children and Families for Small Business Innovation Research SBIR and Small Business Technology Transfer STTR Grant Applications PHS In this proposal we seek to address a critical outstanding need for a robust thermally stable inactivated polio vaccine IPV that will benefit the global effort to eradicate polio and meet pos eradication immunization needs Current IPV products are sensitive to both freezing and elevated temperatures and therefore must be shipped and stored between and C a requirement that imposes financial and logistical challenges in the global distribution of IPV A thermostable IPV formulation would simplify access in areas of the world that lack sufficient cold chain capacity and decrease cold chain associated costs for vaccine manufacturers national governments and non profit vaccine buyers We will focus on stabilization of poliovirus antigens using a novel approach based on silk Specifically we aim to identify lead candidate liquid and solid formulations of a silk IPV complex with improved stability and equivalent immunogenicity compared to the existing commercial IPV formulation Through the proposed research we expect to gain a deeper fundamental understanding of silk vaccine interactions that will guide formulation development Furthermore we expect to gain a better understanding of the immunogenicity of the silk protein itself as well as the impact of silk protein on the immunogenicity of poliovirus antigens These insights are crucial to establish proof of concept and advance the technology into Phase II studies Successful stabilization of IPV would not only have significant positive impact on global polio immunization efforts but may also revolutionize the broader approach to vaccine development and distribution PUBLIC HEALTH RELEVANCE Development of an inactivated polio vaccine that does not require refrigeration would simplify distribution and decrease costs in the global effort to eradicate polio The proposed work will address the need for a thermostable inactivated polio vaccine using a novel stabilization technology based on silk