NOVEL MUCOSAL VACCINE APPROACHES FOR PNEUMONIA KLEBSIELLA

治疗克雷伯氏肺炎的新型粘膜疫苗方法

• 批准号: 10863795
• 负责人: ELIZABETH NORTON
• 金额: $ 88.11万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-23 至 2025-03-06
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10863795
• 关键词: Advanced Development; Animal Model; Clinical; Communicable Diseases; Contracts; Disease Outbreaks; Emerging Communicable Diseases; Event; Formulation; Individual; Klebsiella; Pneumonia; Safety; Toxicology; Vaccines; biodefense; efficacy evaluation; efficacy testing; immunogenicity; manufacture; mucosal vaccine; novel; 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 and biodefense events. 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，以供在故意释放或应对自然发生的传染病爆发（包括新出现的传染病和生物防御事件）后使用。该合同可能支持各个疫苗成分的配制和制造，以及动物模型中的稳定性测试、非临床免疫原性和功效测试、支持 GLP 毒理学的 IND、提交 IND 以及临床安全性和功效评估。