Intranasal, rapid-acting vaccine for all seasonal and pandemic influenza viruses

世界各地的研究人员一直在努力开发一种通用的流感疫苗，但尚未取得突破。FLUniversal并不是“另一个昂贵的通用流感项目”。这是一个创造真正的通用流感疫苗的机会，它将为快速、有效的疫苗开发制定标准，并为开发下一代疫苗提供专门知识和工具。我们计划利用我们对流感感染和免疫的分子机制的进一步了解来开发一种有效对抗所有流感病毒株的疫苗。我们的创新使用了基因改良的流感病毒株，通过鼻内给药。这种方法在鼻腔通道中迅速诱导干扰素和广泛交叉中和抗体，并针对保守的血凝素梗产生系统性免疫反应。在雪貂身上证明了普遍保护的概念；我们现在提议在人类身上证明这一概念。先前的临床研究证实了其在人体中的安全性和免疫原性。菌株在Vero细胞中有效地产生。FLUniversal的目标与预期结果一致：临床前模型的全面免疫学评估，人类挑战模型的开发，以及协助卫生保健利益相关者就支持疫苗开发做出决策。联盟成员在临床前模型、临床试验、免疫学和验证分析方面的世界领先专业知识将为保护机制提供有价值的见解。拟议的临床研究将提供关键的概念临床证据，推动疫苗走向商业化。

Project summary Researchers worldwide have been working to develop a universal flu vaccine, but no breakthrough has yet been achieved. FLUniversal is not "another costly universal flu project". It is an opportunity to create a genuine universal flu vaccine that will set the standard for rapid, efficient vaccine development, and generate know-how and tools to develop next-generation vaccines. We plan to exploit our increased understanding of molecular mechanisms of influenza infection and immunity to develop a vaccine effective against all flu virus strains. Our innovation uses genetically modified flu strains administered intranasally in a prime-boost regimen. This approach rapidly induces interferon and broadly cross-neutralising antibodies in the nasal passages and a systemic immune response directed to the conserved HA stalk. Proof of concept for universal protection was demonstrated in the ferret; we propose now to show proof of concept in humans. Previous clinical studies established safety and immunogenicity in humans. The strains are efficiently produced in Vero cells. FLUniversal's objectives align with the Expected Outcomes: comprehensive immunological assessment of preclinical models, development of a human challenge model, and assisting healthcare stakeholders’ decision-making about support for vaccine development. Consortium members’ world-leading expertise in preclinical models, clinical trials, immunology and validated assays will provide valuable insights on mechanisms of protection. Proposed clinical studies will provide crucial clinical proof of concept to advance the vaccine toward commercialisation.