Development/production of universal influenza vaccines

通用流感疫苗的开发/生产

• 批准号: 10497769
• 负责人: Jason Gall
• 金额: $ 165.21万
• 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/10497769
• 关键词: Clinic; Clinical Research; Clinical Trials; Development; Effectiveness; Evaluation; Future; Human; Human Volunteers; Immunity; Laboratories; Monitor; National Institute of Allergy and Infectious Disease; Phase I/II Clinical Trial; Placebos; Plants; Production; Safety; Seasons; Techniques; Testing; Vaccine Production; Vaccines; Virus; base; clinical material; immunogenicity; influenza virus strain; influenza virus vaccine; manufacturing process; nanoparticle; phase II trial; programs; universal influenza vaccine

Influenza vaccines conferring immunity against multiple strains of virus will be developed at the VPP and manufactured through the VCMP for human clinical trials in compliance with current Good Manufacturing Practices (cGMP) and released for use in human clinical trials in healthy human volunteers. These vaccines may 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 these vaccines in human trials, further evaluation may take place in larger (Phase 2) trials which will necessitate production of the clinical trial materials (CTM) at larger scale. Such vaccines would be effective over multiple seasons and would require lengthy clinical study and monitoring for effectiveness across strains that vary from season to season. Vaccines under development include nanoparticle-based vaccines specific to certain influenza strains as well as more broadly applicable or universal influenza vaccines. Future vaccines will include VLP based approaches.

赋予针对多种病毒株的免疫力的流感疫苗将在 VPP 开发，并通过 VCMP 生产，用于符合现行良好生产规范 (cGMP) 的人体临床试验，并在健康人类志愿者中用于人体临床试验。这些疫苗可以在几年内针对多种毒株提供广泛的免疫力，即“通用流感疫苗”，而季节性产品仅适用于一个季节。如果这些试验在人体试验中证明了这些疫苗的安全性和免疫原性，则可能会在更大规模（第二阶段）试验中进行进一步评估，这将需要更大规模地生产临床试验材料（CTM）。此类疫苗将在多个季节有效，并且需要长期的临床研究和监测不同季节不同菌株的有效性。正在开发的疫苗包括针对某些流感毒株的纳米颗粒疫苗以及更广泛适用或通用的流感疫苗。未来的疫苗将包括基于 VLP 的方法。