FLUniveral Consortium
FLUniversal aims to bring together leading academic and scientific organisations with industry partners to develop a next-generation influenza vaccine and significantly contribute to improving vaccine development practices. Consortium members are leaders in their disciplines and ideally complement each other to add unique value to vaccine development and ensure the effectiveness of the project. The consortium covers all aspects required for successful execution of the project goals, such as experience in vaccine development, strain generation and manufacturing, performing preclinical and clinical trials, know-how in establishing human challenge models for infectious diseases, having validated assays for all influenza immunogenicity parameters, having innovative immunological tools available and access to the newest strains, standards and reagents.
FLUniversal consists of three university beneficiaries, a national health institute and four SMEs, all with leading expertise in influenza vaccine research and development or R&I project management. The consortium is exceptionally strong, interdisciplinary, and intersectional. It uniquely combines scientific, technological and project management expertise.
In this section, we summarise each consortium member's unique individual contribution to the interest in participating in this project.
Vivaldi Biosciences (VIVA) is an Austrian SME. VIVALDI AG’s Chief Scientific Officer, Dr. Muster, has decades-long experience in vaccine development and immunogenetics and led the successful EU-funded programmes FLUVACC #518281 and SSP5B INFLUENZA and is currently Co-PI of a grant funded by the NIH. Contribution to the project: Vivaldi AG’s expertise includes influenza vaccine strain development and optimisation using proprietary reverse genetics and plasmid rescue techniques, gene cloning and sequencing, preclinical and clinical studies, cell-based manufacturing and regulatory affairs.
Contribution to the project:
Vivaldi AG brings its proprietary DeltaFLU technology, Vero-cell-based vaccine manufacturing process, and GMP-compliant production expertise to the project.
Leiden University Medical Center (LUMC) in The Netherlands is a modern medical centre for research, education and patient care with a strong scientific orientation. LUMC plays a leading role in Europe in developing and integrating solutions for healthcare issues.
Contribution to the project:
LUMC has longstanding experience in preparing protocols for clinical studies and healthcare research projects.
Statens Serum Institute (SSI) in Denmark works under the auspices of the Danish Ministry of Health. It is one of the few European government-sponsored health institutions specialising in infectious disease research. SSI’sv main duty is to ensure preparedness against infectious diseases and biological threats.
Contribution to the project:
SSI has unique experience working with Syrian golden hamster-based animal models in pre-clinical research, which is essential for the FLUniversal project.
The Italian SME, VisMederi SRL, specialises in research and qualified services for companies in the life sciences and public health.
Contribution to the project:
VISMEDERI SRL has a unique competence in GCLP-accredited qualified sample analysis, which is one of the clinical study's most expensive and critical tasks. VISMEDERI SRL's accreditation and unquestioned experience are irreplaceable in this project.
The Centre for Human Drug Research (CHDR) is an independent nonprofit institute specialising in innovative early-stage clinical drug research. CHDR provides the new generation of live-attenuated virus-based challenge models, a key output of the project. The challenge strain itself is GMP-produced and tested by MHRA.
Contriubtion to the project:
CHDR´s unique contribution to the project is its capacity to perform contained trial studies, which are essential for vaccination studies with live-attenuated viruses in the challenge studies.
Meditox S.R.O (MEDITOX) is a GLP-certified Czech CRO dedicated to nonclinical and pre-clinical research and development, with experience in conducting exploratory, PoC and regulatory experiments in full compliance with GLP standards and international guidelines (EMA, ICH/VICH, OECD, US FDA, ISO).
Contribution to the project:
Meditox is one of the best candidates to cooperate with in conducting the trials, as it has all the required international certifications and is one of the most cost-efficient CROs in this field in Europe.
As Associated Partner, MHRA (more specifically that part of it which was previously known as the NIBSC), is a UK organisation. MHRA is the leading WHO Collaborating Centre and International Laboratory for Biological Standards and is the only one of the four WHO Essential Regulatory Laboratories (ERL) for Influenza that is in Europe. MHRA is an essential member of FLUniversal since it provides unique resources and expertise required for the development of the controlled human infection model and influenza challenge strain. MHRA has access to influenza viruses from WHO labs worldwide and has the reagents, assays and models needed to evaluate, characterize and select from these viruses a challenge strain for GMP production and use in the challenge model.Moreover, MHRA has experience in the identification and characterisation of potential challenge viruses through its participation in Inno4Vac. (link https://www.inno4vac.eu/)
Contribution to the project:
MHRA’s experience in virus characterisation and animal models will enable the efficient selection of potential human challenge strains. The consortium will also benefit from MHRA’s expertise in standardization which will be used across work packages to ensure comparable results are obtained. (For purposes of clarity, VIVALDI AG, with LUMC and CHDR [and not MHRA], is responsible for regulatory procedures in the consortium.)
Zafiro Business Solutions (ZAFIRO) is a Hungarian SME with decade-long consulting and project management experiences in R&I consortium projects.
Contribution to the project:
ZAFIRO has great experience in managing large projects, coordinating complex EU-financed R&I activities. ZAFIRO’s main role is to enforce and supervise the audit-proof, cost-efficient project execution to ensure that EC funds are spent efficiently and the project achieves its objectives. ZAFIRO is the Coordinator of the project.