US-based late-stage biotechnology company Novavax has started a pivotal Phase III clinical trial for its influenza vaccine, NanoFlu.
NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine containing the company’s patented saponin-based Matrix-M adjuvant.
The vaccine is produced in Novavax’s SF9 insect cell baculovirus system and uses HA amino acid protein sequences.
The recombinant quadrivalent seasonal influenza vaccine candidate will be evaluated in adults aged 65 and over in the randomised, observer-blinded, active-controlled trial.
The primary objective of the trial is to assess the immunogenicity and safety of NanoFlu with its proprietary Matrix-M adjuvant against a US licensed quadrivalent comparator.
Approximately 2,650 healthy older adults will be enrolled across 19 clinical sites in the US. The first participants have already been enrolled.
Participants will be divided into two arms, each consisting of 1,325 adults, and will be administered either NanoFlu or the comparator.
Novavax Research and Development president Gregory Glenn said: “We believe that NanoFlu represents a significant advance in influenza vaccine development and could provide meaningful advantages in protecting older adults against influenza.
“We have shown that NanoFlu, a Matrix-M adjuvanted recombinant nanoparticle, elicits antibodies that neutralise the predicted circulating viruses, historic circulating viruses, and the newly evolved H3N2 viruses.
“In addition, the induction of robust flu specific effector T cells in older adults further distinguishes NanoFlu from licensed comparators. We expect that the use of accelerated approval pathway will make this needed vaccine available to the public sooner. ”
Data from the trial is expected to be available in the first quarter of next year.
The results would support a US biologics license application (BLA) to be submitted in the future.
The company will use the US Food and Drug Administration’s (FDA) accelerated approval pathway for the licensure of NanoFlu.