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

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.

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More information & hyperlinks
Web resources: https://cordis.europa.eu/project/id/101080692
Start date: 01-06-2023
End date: 31-05-2027
Total budget - Public funding: 7 567 787,50 Euro - 7 567 787,00 Euro
Cordis data

Original description

"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.

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Status

SIGNED

Call topic

HORIZON-HLTH-2022-DISEASE-06-03-two-stage

Update Date

31-07-2023
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Horizon Europe
HORIZON.2 Global Challenges and European Industrial Competitiveness
HORIZON.2.1 Health
HORIZON.2.1.0 Cross-cutting call topics
HORIZON-HLTH-2022-DISEASE-06-two-stage
HORIZON-HLTH-2022-DISEASE-06-03-two-stage Vaccines 2.0 - developing the next generation of vaccines
HORIZON.2.1.4 Infectious Diseases, including poverty-related and neglected diseases
HORIZON-HLTH-2022-DISEASE-06-two-stage
HORIZON-HLTH-2022-DISEASE-06-03-two-stage Vaccines 2.0 - developing the next generation of vaccines