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

针对所有季节性和大流行性流感病毒的鼻内速效疫苗

• 批准号: 10080057
• 金额: $ 43.17万
• 依托单位: MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY
• 依托单位国家: 英国
• 项目类别: EU-Funded
• 财政年份: 2023
• 资助国家: 英国
• 起止时间: 2023 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=10080057
• 关键词: Intranasal; rapid; acting; vaccine; seasonal

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.

世界各地的研究人员一直在努力开发通用流感疫苗，但尚未取得突破性进展。FLUniversal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，将为快速，有效的疫苗开发制定标准，并产生开发下一代疫苗的专业知识和工具。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，开发一种有效对抗所有流感病毒株的疫苗。我们的创新使用转基因流感病毒株，以初免-加强方案鼻内给药。这种方法在鼻道中快速诱导干扰素和广泛的交叉中和抗体，以及针对保守的HA茎的全身免疫应答。在雪貂身上证明了普遍保护的概念;我们现在建议在人类身上证明概念。先前的临床研究确定了在人体中的安全性和免疫原性。所述菌株在Vero细胞中有效地产生。FLUniversal的目标与预期成果一致：对临床前模型进行全面的免疫学评估，开发人类挑战模型，并协助医疗保健利益相关者做出支持疫苗开发的决策。联盟成员在临床前模型、临床试验、免疫学和经验证的检测方面的世界领先的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临床概念证明，以推动疫苗的商业化。