GSK plc has announced positive headline results of a phase II trial (NCT06431607) for its mRNA seasonal influenza vaccine programme. The trial studied a range of mRNA formulations in older and younger adults to evaluate vaccine candidates that could improve immune responses against influenza A and B strains, compared to the current standard of care.
· A vaccine candidate formulation demonstrated positive A and B strain immune responses relative to standard of care in both younger and older adults
· mRNA platform elicits strong overall antibody titres with an acceptable safety profile
· Data support progression to phase III clinical trials
In both younger and older adults, pre-defined success criteria were met. Interim data suggest the vaccine candidates have an acceptable safety and reactogenicity profile for all mRNA formulations tested.
These results build on the previous phase II trial and confirm the mRNA platform elicits strong overall antibody titres with an acceptable safety profile. With these results, the GSK mRNA seasonal influenza vaccine programme will progress into late-stage clinical development.
GSK’s Chief Scientific Officer, Tony Wood said: “This marks a significant advancement in our mRNA programme and these data support moving into late-stage development. Ultimately, our goal is to develop a new best-in-class vaccine to bring greater protection to people through the influenza season.”
GSK recently signed a new licensing agreement with CureVac to assume full control of developing and manufacturing influenza and COVID-19 candidate vaccines. GSK continues to develop and optimise its mRNA capabilities through investments and partnerships, including in AI/ML-based sequence optimisation, nanoparticle design and manufacturing.
