US-based biopharmaceutical firm Novavax has started patient enrolment in a Phase II clinical trial of its recombinant quadrivalent seasonal influenza virus-like particle (VLP) vaccine candidate (Seasonal Influenza VLP).
The randomised, observer-blinded, dose-ranging trial is designed to evaluate the safety and immunogenicity of the Seasonal Influenza VLP in 400 healthy adult subjects.
The trial’s primary outcomes will be to evaluate the safety and tolerability of the Seasonal Influenza VLP and quantify immune responses to each of the four influenza strains based on hemagglutination-inhibiting antibody titers.
Additionally, secondary outcomes of the trial will evaluate neuraminidase-inhibition antibody titers for all four influenza strains.
The trial is being conducted as part of the company’s contract with the US Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA) for the development of its recombinant vaccines to address seasonal influenza and influenza strains with pandemic potential.
Novavax president and CEO Stanley Erck said: "We believe this vaccine has the potential to provide a differentiated immune response through the presentation of both hemagglutinin and the intact neuraminidase antigen.
"That differentiated immune response has the potential to deliver more robust protection against infection. We are committed to moving this product from this current trial into clinical efficacy trials."
The company’s technology platform allows the creation of recombinant, strain-specific VLPs.
The Seasonal Influenza VLP includes VLPs representing four different strains of influenza virus, each expressing strain-specific hemagglutinin and neuraminidase antigens.
The company said that antibodies to both hemagglutinin and neuraminidase have been shown to contribute resistance to influenza illness.
As these VLP builds elicit immune responses to both hemagglutinin and neuraminidase molecules in the four strains of seasonal influenza, it is expected that immunised subjects will be protected from influenza infection and disease-related symptoms.