The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to develop a new self-administered vaccine for COVID-19 using a novel oral delivery platform. This project will develop a new technique to generate a strong immune response. It can be used in formulating and evaluating potential vaccines for many diseases, strongly supporting public health. This Small Business Innovation Research (SBIR) Phase I project proposes to develop an orally administered recombinant subunit vaccine targeting SARS-CoV-2. This will be achieved by adsorbing C-type lectin receptor agonist (mannan) and the target antigen (receptor binding domain subunit of spike protein) to aluminum adjuvant, followed by enteric microencapsulation for oral delivery, and spray drying. This platform has been shown to successfully induce mucosal immune response, which is ideal to protect against SARS-CoV-2, which enters via mucosal surfaces. This project will also help advance the technology by further developing analytical assays and optimizing the spray drying processes. Biophysical characterization of the target antigen RBD and formulation development and will first be conducted to achieve good antigen physical stability. Then, dried powder processes will be investigated and optimized. The stability of the dried powders will be analyzed in vitro by particle size, ELISA, during accelerated stability at high temperatures, and in vivo in mouse immunogenicity studies, to further understand the manufacturing process and its impact on vaccine stability and potency.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.
