FLU-v is comprised of four synthetic peptides predicted in silico to cover heavily conserved immunogenic regions of influenza A and B viral proteins M1, M2 and NP-A and NP-B. These internal viral proteins evolve more slowly than the surface proteins traditionally targeted by classical influenza vaccines, which require updating every year.
The FLU-v vaccine aims to elicit a broadly protective immune response through viral clearance by cytotoxic T cell release of pro-inflammatory cytokines, as well as perforin and granzyme.
FLU-v has demonstrated safety, immunogenicity, and clinical efficacy in preclinical work and in Phase I and Phase II clinical studies. A Phase IIb H1N1 challenge trial in healthy adults observed a significant reduction in mild to moderate cases of influenza disease and fewer participants reporting two or more symptoms with FLU-v, compared to placebo.
Having met clinical efficacy and safety endpoints in Phase 1 and Phase 2 studies, FLU-v is now ready for Phase 3 development.
FLU-v clinical development
Phase 1b safety and immuno study (Pleguezuelos et al, 2012, Vaccine)
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Phase 1b H3N2 challenge study (Pleguezuelos et al, 2015, Clin Vaccine Immunol)
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Phase 2b field study (Pleguezuelos et al, 2020, Annals of Internal Medicine)
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Phase 2b H1N1 challenge study (Pleguezuelos et al, 2020, NPJ Vaccines)
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FLU-v manufacture and storage
FLU-v vaccine peptides are synthesised using the egg-free Fmoc chemistry process and can be shipped and stored at room temperature in API lyophilised powder form for 3 months (up to 2 years at 20°C). The powder is then combined with non-metal based MontanideTM ISA-51 adjuvant and water for injection immediately prior to use.
Key publications
Stoloff GA, Caparros-Wanderley W. Synthetic multi-epitope peptides identified in silico induce protective immunity against multiple influenza serotypes. Eur J Immunol, 2007, 37:9, 2441-9. doi: 10.1002/eji.200737254
Pleguezuelos et al. Synthetic Influenza vaccine (FLU-v) stimulates cell mediated immunity in a double-blind, randomised, placebo-controlled Phase I trial. Vaccine, 2012, 30:31, 4655-4660. doi: 10.1016/j.vaccine.2012.04.089
Pleguezuelos et al. A Synthetic Influenza Virus Vaccine Induces a Cellular Immune Response That Correlates with Reduction in Symptomatology and Virus Shedding in a Randomized Phase Ib Live-Virus Challenge in Humans. Clin Vaccine Immunol., 2015, 22:7; 828-35. doi: 10.1128/CVI.00098-15.
Pleguezuelos et al. Immunogenicity, safety, and efficacy of a standalone universal influenza vaccine, FLU-v, in healthy adults. Annals of Internal Medicine, 2020, 172:7, 453-462. doi:10.7326/M19-0735
Pleguezuelos et al. Efficacy of FLU-v, a broad-spectrum influenza vaccine, in a randomized phase IIb human influenza challenge study. NPJ Vaccines, 2020, 5:22, doi: 10.1038/s41541-020-0174-9