SBIR Phase I: At home, single dose mRNA vaccine patch (COVID-19)

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The broader impact / commercial potential of this Small Business Innovation Research (SBIR) Phase I project will be to provide a new vaccine for the COVID-19 pandemic. To date millions have been infected, with hundreds of thousands of deaths. Leading vaccine candidates in clinical trials require two doses, resulting in either: 1) increased spread due to lack of isolation, or 2) incomplete vaccination due to non-compliance. Successful development of a single-dose, self-applied vaccine would not only have a significant positive impact on global COVID-19 immunization efforts, but may also trasnsform the general approach to vaccine delivery and distribution. This project advances the understanding of using a novel at-home device as a vaccination tool for many diseases, broadly aiding public health.This Small Business Innovation Research (SBIR) Phase I project seeks to combine a silk-based microneedle patch with an mRNA-lipid nanoparticle (LNP) construct to meet the global need for a robust COVID-19 vaccine. Combining the unique properties of silk fibroin, a low-cost biomaterial, with a single-dose, self-applied microneedle patch represents a novel approach to vaccination and will result in improved protection by allowing the target antigen to slowly release over two weeks. Additionally, the use of mRNA encoding SARS-CoV-2 peptides that produce neutralizing antibodies against the spike protein and mitigate potential issues from antibody-dependent enhancement will ultimately result in a safer and more effective vaccine. The goal of the proposed research is to demonstrate lead formulations of a silk-mRNA-LNP complex that will be thermally stable and identify a release profile of target antigen to improve SARS-CoV-2 immunogenicity. Results from preliminary in vitro formulation screens and in vivo dosing and scheduling will be used to develop the formulations for the silk microneedle patch in Phase II studies. This project will identify lead candidate silk-mRNA-LNP shelf-stable formulations with improved immunogenicity that is at least equivalent to traditional, non-formulated injections, while offering critical insight into broader implications of mRNA-based vaccinations and sustained release.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.