Cnossen Victor M, Moreira Paula C Leao, Engelhardt Othmar G, Samolej Jerzy, Groeneveld Geert H, Jochems Simon P, Huisman Wesley, Pedersen Gabriel K, Wørzner Katharina, Recek Lukas, Piccini Giulia, Trombetta Claudia M, Aspelund Amy, Hoag Alaura, Reiter Manfred, Wick Carrie, Muster Thomas, Kamerling Ingrid Maria Catharina
Centre for Human Drug Research, Leiden, Netherlands.
Medicines and Healthcare Products Regulatory Agency, Potters Bar, United Kingdom.
Front Immunol. 2025 May 23;16:1568778. doi: 10.3389/fimmu.2025.1568778. eCollection 2025.
Influenza is a significant global health problem, causing disease and hospitalisations in elderly individuals and infants. While updated vaccines are available every year, their effectiveness is moderate at best. FLUniversal is a European Union funded consortium, aiming to develop a universal influenza vaccine by bringing together partners with expertise in different areas of vaccine development. An intranasal live attenuated vaccine, DeltaFLU, will be produced using an innovative platform; preclinical assessment in animal models and clinical studies using a controlled human infection model (CHIM) will be conducted for assessment of safety, immunogenicity and protective efficacy; and finally, comprehensive immunological analysis of blood and nasal mucosa will elucidate vaccine responses and potential new correlates of protection (CoPs). In addition to a universal influenza vaccine, listed as a top priority by the EU, FLUniversal seeks to deliver an enhanced vaccine manufacturing technology that is superior in terms of efficiency, production costs and production speed - especially critical in the face of a potential new pandemic. Moreover, an influenza CHIM with a focus on harmonisation of clinical procedures and assays will be established to generate translatable and reproducible data. Newly generated knowledge on mechanisms of protection, CoPs and new molecular analysis tools may significantly contribute to our knowledge on influenza infection and influenza vaccines. In conclusion, FLUniversal is an innovative and ambitious public-private partnership, aiming to present a new development pathway for influenza vaccines, and maximising impact by bringing together leading partners from academy and industry with a shared purpose of collaboration and innovation.
流感是一个重大的全球健康问题,会导致老年人和婴儿患病并住院。虽然每年都有更新的疫苗,但它们的效果充其量只能说是中等。FLUniversal是一个由欧盟资助的联盟,旨在通过汇聚疫苗研发不同领域的专业合作伙伴来开发一种通用流感疫苗。将使用创新平台生产一种鼻内减毒活疫苗DeltaFLU;将在动物模型中进行临床前评估,并使用受控人类感染模型(CHIM)进行临床研究,以评估安全性、免疫原性和保护效力;最后,对血液和鼻黏膜进行全面的免疫学分析,将阐明疫苗反应和潜在的新的保护相关因素(CoP)。除了欧盟列为首要优先事项的通用流感疫苗外,FLUniversal还寻求提供一种在效率、生产成本和生产速度方面更具优势的先进疫苗生产技术——这在面对潜在的新大流行时尤为关键。此外,将建立一个专注于临床程序和检测方法协调统一的流感CHIM,以生成可转化和可重复的数据。关于保护机制、CoP和新分子分析工具的新生成知识可能会极大地增进我们对流感感染和流感疫苗的了解。总之,FLUniversal是一个创新且雄心勃勃的公私合作伙伴关系,旨在为流感疫苗呈现一条新的发展路径,并通过汇聚来自学术界和产业界的领先合作伙伴,以协作和创新的共同目标实现最大影响。