A grant of €7.6 million from the European Union will contribute to the efforts of a consortium of academic and industry partners that is advancing the development of a universal influenza vaccine. The FLUniversal programme will set out to conduct clinical trials of DeltaFLU, a rapid-acting universal influenza vaccine for intranasal administration, and to elucidate molecular and immunological mechanisms of protection. Furthermore, it aims to identify potential new correlates of protection. The partnership will develop a controlled human infection model (CHIM) and influenza challenge strain that will be used to evaluate the protective efficacy of DeltaFLU in a challenge study.
Bringing experts together
The consortium unites “world-leading experts”, says Dr Ed Schmidt, Project Manager at Leiden University Medical Centre (LUMC). Dr Schmidt recognises that influenza is a “major public health problem globally” and suggests that a universal vaccine is an “urgent goal”. The FLUniversal consortium will use the “tools and knowledge” of these experts to create a novel vaccine that has already “surmounted key hurdles of novel vaccines”. It has demonstrated “safety and robust immunogenicity in humans and manufacturability”.
“Our synergistic combination of preclinical models, a CHIM to produce results similar to wild-type infection, clinical samples, and integrated complex immunological analyses for a unique platform to identify molecular signatures of protection and reduce the timeline and risks involved in clinical development.”
Vivaldi Biosciences
FLUniversal partner Vivaldi Biosciences developed and owns the DeltaFLU universal influenza vaccine, which is based on virus strains genetically modified to eliminate the NS1 gene. This modification allows DeltaFLU to “rapidly induce interferon and broadly cross-neutralising antibodies in the nasal passages”. It generates protection at the point of entry of influenza viruses and establishes tissue-resident memory T cells to protect against repeat infection.
As NS1 is deleted, DeltaFLU is safe; the modified strains are unable to produce viral progeny and are not shed. Vivaldi reports that it has demonstrated safety and broad immunogenicity of DeltaFLU vaccine strains in clinical trials and achieved proof-of-concept for unviersal protection against influenza A and B strains in animal models.
The consortium
Each member contributes a significant role to the project. LUMC and the Centre for Human Drug Research are responsible for clinical studies within the programme. These include a Phase I study of safety and immunogenicity, and a clinical challenge study to demonstrate protective efficacy. Vivaldi takes the lead on GMP manufacture of the DeltaFLU vaccines and novel challenge strain using the high-yield Vero cell production system.
The UK’s MHRA is participating as an associate partner and will be responsible for the isolation, selection, and characterisation of the novel influenza virus challenge strain. MediTox is a GLP-certified CRO with expertise in nonclinical pharmacology and toxicology studies; it will conduct preclinical studies. Studies in the ferret model will evaluate safety, immunogenicity, and challenge-protection. DeltaFLU will also be studied in the Syrian golden hamster model for the identification of “immune fingerprints” that corelate with protection against transmission from infected to immunised animals.
Statens Serum Institut will evaluate the samples from the studies to identify correlates of protection. VisMederi will carry out integrated complex immunological assays to identify molecular signatures of protection. Zafiro Business Solutions acts as the programme coordinator, managing the project and ensuring compliance with ethics requirements.
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