ADVANCED DEVELOPMENT OF A VACCINE FOR PANDEMIC AND PRE-EMERGENT CORONAVIRUSES

针对大流行和突发冠状病毒的疫苗的高级开发

• 批准号: 10710595
• 负责人: KEVIN SAUNDERS
• 金额: $ 1124.82万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-19 至 2026-09-18
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10710595
• 关键词: Advanced Development; Animal Model; COVID-19 vaccine; Clinical; Communicable Diseases; Contracts; Disease Outbreaks; Emerging Communicable Diseases; Formulation; Individual; SARS coronavirus; Safety; Toxicology; Vaccines; efficacy evaluation; efficacy testing; immunogenicity; novel coronavirus; pandemic disease; response; stability testing; vaccine development

To support the advanced development of candidate products for use following the intentional release of or in response to naturally occurring outbreaks of infectious diseases, including emerging infectious diseases. This contract may support formulation and manufacture of the individual vaccine components, as well as stability testing, nonclinical immunogenicity and efficacy testing in animal models, IND enabling GLP toxicology, submission of an IND and clinical safety and efficacy evaluation.

支持候选产品的高级开发，以便在故意释放传染病（包括新出现的传染病）之后使用或应对自然发生的传染病暴发。该合同可支持单个疫苗组分的配制和生产，以及动物模型中的稳定性试验、非临床免疫原性和有效性试验、IND启用GLP毒理学、IND提交以及临床安全性和有效性评价。