Novavax announced Wednesday that the first participants have been enrolled in a Phase I/II trial evaluating a combination of the company's recombinant protein-based NVX-CoV2373 and NanoFlu vaccine candidates in a single formulation. Both NVX-CoV2373 and NanoFlu are currently in late-stage development as standalone vaccines against COVID-19 and seasonal influenza, respectively.
The study will evaluate NVX-CoV2373 formulated together with NanoFlu and Novavax's saponin-based Matrix-M adjuvant in 640 healthy adults between the ages of 50 and 70, who will either have been previously infected with the SARS-CoV-2 virus or vaccinated against COVID-19 at least eight weeks before. Participants will be randomised into cohorts testing multiple formulations and be dosed on day 0 and again at day 56.
Gregory Glenn, president of R&D at Novavax, said "this study is the first-of-its-kind to evaluate the vaccine's potential to induce a robust immune response…against two life-threatening diseases simultaneously." If it proves effective, Glenn suggested the combination could also lead to "greater efficiencies" for the healthcare system. The trial, which will be conducted in Australia, is expected to have results in the first half of 2022.
Novavax noted that in preclinical testing, the combination of NVX-CoV2373 and NanoFlu induced "robust, functional immune responses" to each component of the quadrivalent influenza vaccine, as well as the SARS-CoV-2 spike protein, with its Matrix-M adjuvant "playing a key role."
NVX-CoV2373 has also been evaluated in a trial when given simultaneously with CSL's approved trivalent or quadrivalent influenza vaccines. Novavax has said findings from that study, which was made available as a preprint in June and submitted for peer review, suggested NVX-CoV2373's efficacy appeared to be preserved in people receiving both vaccines compared to those given only NVX-CoV2373.
On its own, NVX-CoV2373 has been tested in a Phase III trial of nearly 30,000 adults in the US and Mexico, with results indicating it conferred full protection against moderate-to-severe COVID-19 infection and was 90.4% efficacy overall. Novavax has said it planned to seek marketing authorisations for the vaccine in the third quarter. Meanwhile, NanoFlu achieved the primary endpoints of another late-stage study evaluating non-inferiority against Sanofi's Fluzone vaccine in adults aged 65 and older.
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