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Novavax Completes Enrollment of Its Seasonal Influenza VLP Vaccine Phase IIa Clinical Trial
Date:9/19/2008

Rapid Seasonal influenza VLP vaccine trial enrollment positions Company to

report top line data in fourth quarter of this year

ROCKVILLE, Md., Sept. 19 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX) announced today it has completed enrollment of healthy volunteers in a Phase IIa clinical trial of its virus-like particle (VLP) based seasonal influenza vaccine. The Phase IIa randomized, placebo controlled clinical trial is evaluating the safety and immunogenicity of different doses of its seasonal influenza VLP vaccine. Specifically, the vaccine will be studied in approximately 300 healthy adults between the ages of 18 and 49 years, who will receive a single injection of either a placebo or an influenza vaccine at doses of 5 mcg, 15 mcg or 30 mcg. The goals of the study are to select a dose for evaluation in a subsequent Phase III efficacy study and to continue the evaluation of safety of its novel influenza VLP vaccines.

VLPs are recombinant structures that mimic the size and shape of a virus but lack genetic material and are therefore incapable of replication. Because they resemble actual infectious particles presenting proteins in the same conformation as on the wild-type virus, they are able to induce potent immune response. Novavax's VLP vaccine may be differentiated from other influenza vaccines in several ways. First, it includes three viral proteins important for inducing a broad immune response including two surface proteins, hemmaglutinin ("HA") and neuraminidase ("NA"), and a core matrix protein, M1. In contrast, most seasonal vaccines consist almost entirely of HA with little or no NA and M1. The HA protein induces antibody that neutralizes or blocks the growth of the virus; NA induces antibodies
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SOURCE Novavax, Inc.
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