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

SBIR 第一阶段：基因工程 BCG 作为基于微生物的 COVID-19 疫苗接种平台

• 批准号: 2029504
• 负责人: Borys Shor
• 金额: $ 25.6万
• 依托单位: MANHATTAN BIOSOLUTIONS, LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-01 至 2022-08-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2029504&HistoricalAwards=false
• 关键词: SBIR; Phase; Genetically; Engineered; BCG

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.

这个小企业创新研究第一阶段项目的更广泛的影响/商业潜力是开发一种安全和负担得起的新冠肺炎疫苗接种技术，在管理其他传染病方面具有更广泛的实用性。新的平台是基于改良的细菌，作为一种安全的儿科结核病免疫有着悠久的历史。这项拟议的技术有望显示出热稳定性、安全性、成本效益和易于大规模生产的特点。它可用于儿童和高危群体，包括急救人员、老年人和有潜在疾病的人。这也可以在新兴和弱势环境中实现。拟议的项目实现了一个基于重组卡介苗(RBCG)的新型微生物疫苗平台，该重组卡介苗旨在针对SARS-CoV-2并预防新冠肺炎。本项目的目标是开发表达SARS-CoV-2蛋白片段的卡介苗，以诱导针对SARS-CoV-2特异性抗原的适当免疫反应。在这个项目中，将根据病毒多肽的生物学特性，选择具有最高分泌和持久表达水平的新的rBCG候选者并进行优先排序。重组卡介苗疫苗将在动物模型中进行安全性和免疫原性评估。未来的临床前研究将选择没有不良反应并能诱导强大的T细胞和抗体反应的有前途的候选人。这一奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。