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Novavax Commences Clinical Testing of its Seasonal Influenza VLP Vaccine Candidate
Date:9/16/2008

Development of influenza VLP vaccines gains momentum with launch of a Phase

IIa study of Seasonal Influenza Vaccine

ROCKVILLE, Md., Sept. 16 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX) announced today vaccination of healthy volunteers in a Phase II clinical trial of its virus-like particle (VLP) based seasonal influenza vaccine. The Phase IIa randomized, placebo controlled clinical trial will evaluate 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 to 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 responses. Novavax's VLP vaccine may be differentiated from other influenza vaccines in several ways. First, it includes three viral proteins (incorporated in the vaccine as three separate VLPs) 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 th
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SOURCE Novavax, Inc.
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