ADVANCED DEVELOPMENT OF LQ A LIPOSOME-BASED SAPONIN-CONTAINING ADJUVANT FOR USE IN PANSARBECOVIRUS VACCINES
ADVANCED DEVELOPMENT OF LQ A LIPOSOME-BASED SAPONIN-CONTAINING ADJUVANT FOR USE IN PANSARBECOVIRUS VACCINES
批准号:
10935820
负责人:
NICOLAS COLLINS
金额:
$144.9万
依托单位:
--
依托单位国家:
美国
项目类别:
财政年份:
2023
资助国家:
美国
项目状态:
未结题
起止时间:
2023-09-30 至 2028-09-29
关键词:
2019-nCoVAccelerationAddressAdjuvantAdvanced DevelopmentAntigensChromatographyClinical ResearchCommunitiesContractorDevelopmentEvaluationFormulationGood Manufacturing ProcessHamstersImmunologic AdjuvantsLiposomesMacaca mulattaMusPharmacologyPhasePreparationQS21QuillajaSARS coronavirusSafetySaponinsSarbecovirusSoapbushToxic effectToxicologyVaccine AdjuvantVaccinescost effectiveefficacy studyglobal healthimmunogenicityinnovationliposome vectormanufacturenanoparticlenovel vaccinespreclinical studyprotective efficacyvaccine accessvaccine developmentvaccine efficacy
中文摘要
该项目将推进一种新疫苗佐剂的开发,以满足对更多Th1诱导和负担得起的佐剂的需求,这些佐剂可公开用于疫苗开发。为了加速这种新佐剂的开发,将在脂质体载体中配制一种创新的、具有成本效益的皂苷组份,并与泛肉瘤病毒疫苗一起配制。这种佐剂最终将提供给整个疫苗社区。该项目包括优化脂质体载体的组成,以及对佐剂的免疫特性进行全面评估。这种辅助剂的保护效果将在包括免疫原性和安全性评估在内的高级临床前研究中进行评估。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,以促进其在第一阶段临床研究中的使用。这一合作努力将有助于加快全球健康影响疫苗的开发。
英文摘要
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.
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