Novavax announced that its seasonal influenza vaccine candidate, NanoFlu, elicited improved immune responses in adults aged 65 and older compared with Sanofi Pasteur’s Fluzone High-Dose, the leading influenza vaccine in older adults, in a phase 2 clinical trial.
The study included 1,375 healthy adults aged 65 years or older. According to a news release, researchers compared the safety and immune responses of various quadrivalent formulations of NanoFlu with or without Novavax’s Matrix-M adjuvant, with two influenza vaccines licensed in the United States. They found that all formulations of NanoFlu were well-tolerated and elicited significant immune response to all four strains of influenza included in the vaccine.
The formulations that included the adjuvant demonstrated enhanced immune response compared with unadjuvanted formulas, Novavax said. Compared with Fluzone High-Dose, NanoFlu demonstrated “significantly superior” antibody responses against wild-type H3N2 viruses, including two drifted strains.
H3N2 viruses are notoriously difficult to protect against and cause relatively severe illness. H3N2 was the predominant strain during the 2017-2018 influenza season — one of the most severe in decades.
“The superior immunogenicity against wild-type H3N2 viruses holds promise that NanoFlu will more effectively address the mismatch between circulating viruses and the strains included in most commercial vaccines due to genetic drift and vaccine virus egg adaptation,” Gregory Glenn, MD, president of research and development at Novavax, said in the release.
Novavax previously announced that the FDA acknowledged that an accelerated approval pathway may be available for NanoFlu. Novavax said it would discuss accelerated approval, phase 2 trial data and phase 3 trial design when it meets with the FDA in the first half of 2019.
“Over the past several years, influenza vaccine effectiveness has been suboptimal in [older adults], and there is broad agreement that better vaccines are needed,” Glenn said in the release. “These confirmatory data from the second clinical trial of NanoFlu further justify continued rapid development of an improved vaccine.” – by Erin Michael
Disclosure: The author reports no relevant financial disclosures.