STUDY PROTOCOL article

Front. Immunol.

Sec. Vaccines and Molecular Therapeutics

Volume 16 - 2025 | doi: 10.3389/fimmu.2025.1568778

This article is part of the Research TopicCommunity Series in Development and Harmonization of Assays and Models to Assess Immunogenicity and Correlates of Protection of Vaccines Against Pathogens Causing Respiratory Infections: Volume 2View all 4 articles

Development of an intranasal, universal influenza vaccine in an EUfunded public-private partnership: the FLUniversal consortium

Provisionally accepted
Victor CnossenVictor Cnossen1*Paula Leao MoreiraPaula Leao Moreira1Othmar EngelhardtOthmar Engelhardt2Jerzy SamolejJerzy Samolej2Geert GroeneveldGeert Groeneveld3,4Simon JochemsSimon Jochems3Wesley HuismanWesley Huisman3Gabriel PedersenGabriel Pedersen5Katharina WørznerKatharina Wørzner5Lukas RecekLukas Recek6Giulia PicciniGiulia Piccini7Claudia TrombettaClaudia Trombetta7,8Amy AspelundAmy Aspelund9Alaura HoagAlaura Hoag9Manfred ReiterManfred Reiter9Carrie WickCarrie Wick9Thomas MusterThomas Muster9Ingrid Maria Catharina KamerlingIngrid Maria Catharina Kamerling1,3
  • 1Centre for Human Drug Research, Leiden, Netherlands
  • 2Medicines and Healthcare products Regulatory Agency, South Mimms, Potters Bar, United Kingdom
  • 3Leiden University Center for Infectious Diseases (LU-CID), Leiden University Medical Center, Leiden, Netherlands
  • 4Department of Internal Medicine - Acute Internal Medicine, Leiden University Medical Center, Leiden, Netherlands
  • 5Center for Vaccine Research, Statens Serum Institute, Copenhagen, Denmark
  • 6MediTox S.R.O., Konárovice, Czechia
  • 7Vismederi srl, Siena, Tuscany, Italy
  • 8Department of Molecular Medicine and Development, University of Siena, Siena, Tuscany, Italy
  • 9Vivaldi Biosciences, Vienna, Austria

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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 maximizing impact by bringing together leading partners from academy and industry with a shared purpose of collaboration and innovation.

Keywords: influenza, Vaccine, Universal influenza vaccine, FLUniversal, Controlled Human Infection Model, Public-Private Partnerships, correlate of protection

Received: 30 Jan 2025; Accepted: 29 Apr 2025.

Copyright: © 2025 Cnossen, Leao Moreira, Engelhardt, Samolej, Groeneveld, Jochems, Huisman, Pedersen, Wørzner, Recek, Piccini, Trombetta, Aspelund, Hoag, Reiter, Wick, Muster and Kamerling. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Victor Cnossen, Centre for Human Drug Research, Leiden, Netherlands

Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.

Supplementary Material