Development/production of universal influenza vaccines

将在VPP开发可对多种病毒株产生免疫力的流感疫苗，并按照现行药品生产质量管理规范（cGMP）通过VCMP生产用于人体临床试验，并放行用于健康人类志愿者的人体临床试验。这些疫苗可以赋予广泛的免疫力，一种“通用流感疫苗”，在几年的时间内对抗多种毒株，而季节性产品仅适用于一个季节。如果这些试验证明了这些疫苗在人体试验中的安全性和免疫原性，则可能在更大规模（2期）试验中进行进一步评价，这将需要以更大规模生产临床试验材料（CTM）。这些疫苗将在多个季节有效，并且需要长时间的临床研究和监测不同季节的菌株的有效性。正在开发的疫苗包括针对某些流感病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。

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 base approaches.