US-based Novavax has reported positive top-line data from a Phase II clinical trial of its recombinant quadrivalent seasonal influenza virus-like particle (VLP) vaccine candidate (Seasonal Influenza VLP).
Under the company’s contract with HHS-BARDA, the trial has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority and the Department of Health and Human Services.
The trial showed that the seasonal influenza VLP vaccine candidate was well-tolerated with no vaccine-related serious adverse events.
In addition to meeting its immunogenicity targets, the trial showed potential to meet the Center for Biological Evaluation and Research (CBER) criteria for accelerated approval.
The company’s technology platform allows the creation of recombinant, strain-specific VLPs.
The seasonal influenza VLP consists of VLPs representing four different strains of influenza virus, each expressing strain-specific hemagglutinin and neuraminidase antigens.
Novavax chief medical officer Louis Fries said: "Titers of antibodies that inhibit hemagglutination by the influenza virus – called hemagglutination-inhibiting or HAI antibodies – remain the best-accepted correlates of the protection provided by influenza vaccines.
"Novavax has made a concerted effort to improve the antigens in our Seasonal Influenza vaccine. In particular, for the two viral strains (out of the four) for which we had sought immunogenic improvement, we showed robust HAI titer responses, approximately 50% greater than those in our prior phase II trial.
"Further, we measured neuraminidase-inhibiting (NAI) antibody responses against seasonal influenza viruses for the first time, and were able to detect significant NAI antibody responses to all four influenza strains, including strong responses against the B virus strains."
Around 400 healthy adults were included in the dose-ranging clinical trial, which was designed to evaluate the safety and immunogenicity of the Seasonal Influenza VLP.
The trial’s primary outcomes evaluated the safety and tolerability of the Seasonal Influenza VLP and quantified immune responses to each of the four influenza strains based on hemagglutination-inhibiting antibody titers.
The secondary outcomes of the trial evaluated neuraminidase-inhibiting antibody titers for all four influenza strains.
Novavax president and CEO Stanley Erck, said: "These positive topline data from the Phase II trial of our Seasonal Influenza vaccine candidate represent an important achievement in this program.
"We expect the next steps in our collaboration will be the initiation of a Phase II clinical trial of the H7N9 vaccine candidate in the adult population in the first quarter of 2016."