Novavax Begins Phase II Flu Vaccine Study

Novavax, Inc. initiated a Phase IIa study of its trivalent seasonal influenza VLP vaccine candidate in healthy adults 60 years of age or older. This randomized, double-blind, active-controlled study is evaluating the safety, tolerability and immunogenicity of two different doses of Novavax’s VLP vaccine compared with a commercially available trivalent inactivated vaccine (TIV, Fluzone). Novavax’s vaccine contains VLPs made up of the hemagglutinin (HA), neuraminidase (NA), and matrix 1 (M1) proteins against the H3N2, H1N1, and B strains recommended for 2009-2010 flu vaccines.

“This is a very important study because it will help establish the safety and immunogenicity of our trivalent seasonal influenza VLP vaccine in older adults and allow us to select a dose for a future Phase IIb confirmatory, non-inferiority clinical trial in this population. Moreover, it will also give us a clear signal of how our seasonal influenza VLP vaccine compares to the current standard of care, TIV (Fluzone),” said Dr. Rahul Singhvi, president and chief executive officer of Novavax. “Recall that in a recent Phase II study in healthy adults ranging in ages from 18-49 years, we showed that our seasonal influenza VLP vaccine was safe and immunogenic at 15 and 60 mcg dose levels. These data give us great confidence as we move forward in this current clinical trial in older adults.”

A total of 480 subjects will be enrolled at approximately six sites in the U.S. and one site in India. Preclinical studies have shown that influenza VLP vaccines have stronger T-cell responses than TIV (Fluzone), indicating the potential for better immunologic responses in trials particularly in older adults.