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.

为了支持候选产品的高级开发，以在有意释放或响应自然发生的传染病爆发后使用，包括新兴的传染病和生物探讨事件。该合同可以支持单个疫苗成分的配方和制造，以及稳定性测试，非临床免疫原性和动物模型中的疗效测试，IDS启用GLP毒理学，提出IND和临床安全和效果评估。