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.

该项目将推动开发新的疫苗佐剂，该辅助辅助剂满足了公开可用于疫苗开发的更多Th1诱导和负担得起的佐剂的需求。将在脂质体载体中制定创新的，具有成本效益的皂苷馏分，并用泛 - 萨尔贝病毒疫苗配制，以加速这种新佐剂的发展。最终将向整个疫苗社区提供该辅助设备。该项目涵盖了脂质体载体组成的优化，以及对佐剂的免疫剖面的全面评估。辅助配方的保护功效将在包括免疫原性和安全评估的高级临床前研究中评估。该项目还包括辅助，药理学和毒性研究的良好制造实践（GMP），以促进其在1阶段临床研究中使用的进展。这种合作的努力将有助于加快全球健康影响疫苗的开发。