Development/production of universal influenza vaccines

通用流感疫苗的开发/生产

• 批准号: 9361515
• 负责人: Richard Schwartz
• 金额: $ 776.41万
• 依托单位: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9361515
• 关键词: Clinic; Clinical Trials; Contracts; DNA Vaccines; Development; Evaluation; Human; Human Volunteers; Immunity; Influenza; Laboratories; National Institute of Allergy and Infectious Disease; Phase; Phase II Clinical Trials; Placebos; Plants; Production; Safety; Seasons; Techniques; Testing; Vaccine Production; Vaccines; Virus; clinical material; immunogenicity; influenza virus vaccine; manufacturing process; preclinical safety; programs; safety study

Influenza vaccines conferring immunity against multiple strains of virus will be manufactured for human clinical trials in compliance with current Good Manufacturing Practices (cGMP) and released for use in human clinical trials in healthy human volunteers. It is hoped that these vaccines will confer broad immunity a "universal influenza vaccine" over a period of several years against multiple strains in contrast to seasonal products that are only useful for a single season. If these trials demonstrate safety and immunogenicity of this vaccine in human trials, further evaluation may take place in larger (Phase 2) trials which will necessitate production of the clinical trial materials (CTM) at large scale.

赋予针对多种病毒菌株的免疫力的流感疫苗将根据当前的良好制造实践（CGMP）生产，并在人类健康的人类志愿者中用于人类临床试验。希望这些疫苗能够在数年内与多种菌株相比，与仅在一个季节有用的季节性产品相比，在几年内，将赋予广泛的免疫力为“通用流感疫苗”。如果这些试验在人类试验中表现出该疫苗的安全性和免疫原性，则可能在较大（第2阶段）的试验中进行进一步的评估，这将需要大规模生产临床试验材料（CTM）。