SBIR Phase I: Genetically Engineered BCG as a Microbe-Based Platform for Vaccination Against COVID-19

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The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to develop a safe and affordable COVID-19 vaccination technology, with broader utility in managing other contagious diseases. The new platform is based on modified bacteria, with a long history as a safe pediatric immunization for tuberculosis. The proposed technology is expected to show heat-stability, safety, cost-effectiveness, and ease of mass production. It can be used for children and at-risk groups including first responders, the elderly, and those with underlying conditions. This can be delivered in emerging and disadvantaged environments as well. The proposed project enables a novel microbial vaccine platform based on recombinant BCG bacteria (rBCG) engineered to target SARS-CoV-2 and protect against COVID-19. The goal of this project is to develop BCG that expresses SARS-CoV-2 protein fragments, which could lead to the induction of appropriate immune responses against SARS-CoV-2 specific antigens. For this project, new rBCG candidates with the highest secretion and durable expression levels of viral polypeptides will be selected and prioritized, based on their biological properties. The rBCG vaccines will be evaluated for safety and immunogenicity in animal models. Promising candidates that show no adverse events and induce robust T-cell and antibody responses will be selected for future preclinical studies.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.