Novavax has started enrolling patients in a Phase II clinical trial of its recombinant quadrivalent seasonal influenza virus-like particle (VLP) vaccine candidate (Seasonal Influenza VLP).
The randomized, observer-blinded, dose-ranging trial will evaluate the safety and immunogenicity of the Seasonal Influenza VLP in 400 healthy adult subjects.
The trial’s primary outcomes will be to assess 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.
Secondary outcomes of the trial will evaluate neuraminidase-inhibition antibody titers for all four influenza strains.
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 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) to develop its recombinant vaccines to address seasonal influenza and influenza strains with pandemic potential.
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.