Development/production of universal influenza vaccines

VPP将开发对多种病毒具有免疫力的流感疫苗，并根据当前的良好制造规范(CGMP)通过VCMP生产用于人体临床试验，并在健康的人体志愿者身上发布用于人体临床试验的疫苗。这些疫苗可能会在几年内对多种毒株产生广泛的免疫力，这是一种“通用流感疫苗”，而季节性产品只对一个季节有效。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，可能会在更大规模的(第二阶段)试验中进行进一步的评估，这将需要更大规模的临床试验材料(CTM)的生产。这种疫苗将在多个季节有效，需要漫长的临床研究和对不同季节不同毒株的有效性监测。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。

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.