GSK and CureVac are looking to build on the momentum of mRNA-based vaccine technology with a new trial targeting seasonal influenza.

The companies have dosed the first subject in a Phase I/II trial (NCT05823974) testing a multivalent mRNA vaccine against four influenza strains, CureVac announced Monday. The study, which takes place in the US and Belgium, will test the safety and immunogenicity of the vaccine candidate against a licensed influenza vaccine comparator.

GSK’s and CureVac’s trial joins a growing list of clinical trials testing mRNA vaccines, after the technology proved surprisingly successful in reducing the risk of severe disease due to Covid-19. Early positive data in respiratory syncytial virus (RSV) and melanoma have now shown that mRNA vaccines could show efficacy in indications beyond Covid-19, and the pharma industry has taken note.

GSK and CureVac mRNA collaboration

After shifting focus away from its first-generation mRNA Covid-19 vaccine, CureVac has set its sights on developing an array of second-generation mRNA vaccine candidates with its collaborator GSK. The two pharma companies first announced plans to collaborate on mRNA vaccine technology and infectious disease drug development in July 2020.

The newly initiated Phase I/II influenza trial will enroll 1,512 healthy adults and has an estimated completion date of June 2024, according to the trial listing. Primary endpoints include measures of safety, antibody titers, and antigen levels.

Meanwhile, the GSK and CureVac collaboration also includes an ongoing Phase I trial of a monovalent mRNA vaccine for seasonal influenza (NCT05446740). CureVac reported that the vaccine candidate had successfully boosted antibody titers in preliminary data announced in January.

mRNA vaccines work by providing cells with instructions to encode specific proteins, which can then prevent infections by eliciting an immune response against the target antigen.

Clarification: This article was updated to correctly reflect Curevac’s development strategy for mRNA vaccines announced in October 2021. A previous version stated CureVac had shifted focus away from Covid-19 vaccines.

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