NanoFlu shows promise in phase 3 trial among older adults
NanoFlu, a recombinant quadrivalent influenza vaccine candidate that has been granted fast track status by the FDA, met all primary endpoints in a phase 3 trial testing its efficacy and overall safety in older adults, Novavax announced.
The trial compared NanoFlu with Fluzone Quadrivalent (Sanofi Pasteur) using the day 28 ratio of geometric mean titers (GMTs), the difference in seroconversion rates (SCRs), and overall safety. It included 2,652 healthy adults aged 65 or older in 19 U.S. clinical sites who were randomly assigned to receive either NanoFlu or the comparator. Researchers followed the participants for 1 year after injection.
According to Novavax, NanoFlu achieved the primary endpoints regarding both GMT and SCR for all four strains included in the vaccine and was well tolerated, with a safety profile comparable with Fluzone Quadrivalent.
Secondary endpoints assessed GMTs and SCRs, but with a hemagglutination inhibition (HAI) assay based on wild-type reagents, “which are expected to provide a more accurate assessment of clinically relevant HAI antibody responses against circulating wild-type viruses.” Results of the trial showed that NanoFlu demonstrated significantly higher GMTs and SCRs than Fluzone Quadrivalent across all four strains included in the vaccine — 24% vs. 66% higher GMT responses and 11.4 vs. 20.4 higher SCR percentage points.
Additionally, researchers found that NanoFlu demonstrated significantly higher GMTs and SCRs than Fluzone Quadrivalent for four H3N2 strains circulating this season that were tested but not included in the vaccine. NanoFlu had 34% to 41% higher GMT responses and 14.1 to 16.8 higher SCR percentage points compared with Fluzone Quadrivalent.
“With these data, we now have a clear path forward to licensure with our differentiated recombinant influenza vaccine,” Novavax President and CEO Stanley C. Erck said in a news release. “These strong phase 3 results align with and validate our previous clinical trials, in which NanoFlu showed higher HAI antibody responses than the leading flu vaccine for older adults. We expect that both fast track designation and the accelerated approval pathway from the FDA will help Novavax bring NanoFlu to market as quickly as possible to address the serious public health threat of influenza.”
Data from a phase 2 clinical trial showed that NanoFlu elicited improved immune responses in older adults compared with Fluzone and that all formulations of NanoFlu were well tolerated and prompted significant immune response to all four strains of influenza included in the vaccine, Novavax said.
Representatives from Novavax said they were not giving specific guidance right now about the timing of FDA approval or launch of NanoFlu. – by Caitlyn Stulpin