Novavax Inc., has announced that patient enrollment has begun in its Phase 2 clinical trial of its new recombinant quadrivalent seasonal influenza virus-like particle vaccine, titled Seasonal Influenza VLP.
The study is looking to enroll 400 subjects.
The VLP is comprised of virus-like particle vaccines that represent four different strains of the flu virus, with antibodies to both hemagglutinin and neuraminidase shown to resist the flu virus.
“We are delighted to announce the initiation of this Phase 2 clinical trial of our Seasonal Influenza VLP,” Stanley C. Erck, president and CEO of Novavax, 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.”
Because the virus-like particle vaccines build direct, immune responses to both hemagglutinin and neuraminidase molecules in the four strains, immunized individuals are protected from the flu and related symptoms.
The primary outcomes of the trial are to address safety and tolerance levels of the Seasonal Influenza VLP and also to calculate immune responses to each of the four flu strains based on hemagglutination-inhibiting antibody titers. Other outcomes will look at neuraminidase inhibition antibody titers, also for all four strains.