ADVANCED DEVELOPMENT OF LQ A LIPOSOME-BASED SAPONIN-CONTAINING ADJUVANT FOR USE IN PANSARBECOVIRUS VACCINES

用于 Pansarbecovirus 疫苗的 LQ A 脂质体含皂苷佐剂的先进开发

• 批准号: 10935820
• 负责人: NICOLAS COLLINS
• 金额: $ 144.9万
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-30 至 2028-09-29
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10935820
• 关键词: 2019-nCoV; Acceleration; Address; Adjuvant; Advanced Development; Antigens; Chromatography; Clinical Research; Communities; Contractor; Development; Evaluation; Formulation; Good Manufacturing Process; Hamsters; Immunologic Adjuvants; Liposomes; Macaca mulatta; Mus; Pharmacology; Phase; Preparation; QS21; Quillaja; SARS coronavirus; Safety; Saponins; Sarbecovirus; Soapbush; Toxic effect; Toxicology; Vaccine Adjuvant; Vaccines; cost effective; efficacy study; global health; immunogenicity; innovation; liposome vector; manufacture; nanoparticle; novel vaccines; preclinical study; protective efficacy; vaccine access; vaccine development; vaccine efficacy

The project will advance the development of a new vaccine adjuvant which addresses the need for more Th1-inducing and affordable adjuvants openly available for vaccine development. An innovative, cost-effective saponin fraction will be formulated within a liposome carrier and formulated with a pan-sarbecovirus vaccine in order to accelerate the development of this new adjuvant. This adjuvant will be made ultimately available to the entire vaccine community. This project encompasses the optimization of the liposome carrier's composition, as well as a comprehensive evaluation of the adjuvant's immune profile. The protective efficacy of the adjuvanted formulation will be evaluated in advanced preclinical studies comprising immunogenicity and safety evaluations. The project also includes the Good Manufacturing Practice (GMP) preparation of the adjuvant, pharmacology and toxicity studies to facilitate its progression towards use in phase 1 clinical studies. This collaborative effort will contribute to accelerate the development of vaccine of Global Health impact.

该项目将推进一种新的疫苗佐剂的开发，以解决对更多th1诱导和可负担得起的佐剂的需求，这些佐剂可公开用于疫苗开发。一种创新的、具有成本效益的皂苷部分将在脂质体载体中配制，并与泛sarbecvirus疫苗配制，以加速这种新佐剂的开发。这种佐剂最终将提供给整个疫苗界。该项目包括脂质体载体组成的优化，以及佐剂免疫谱的综合评估。佐剂配方的保护功效将在高级临床前研究中进行评估，包括免疫原性和安全性评估。该项目还包括佐剂的良好生产规范（GMP）制备、药理学和毒性研究，以促进其在1期临床研究中的应用。这一合作努力将有助于加速开发具有全球卫生影响的疫苗。