Novavax begins study comparing VLP vaccine with Fluzone

ROCKVILLE, Md. — Novavax Inc. has begun a Phase IIa clinical study of its trivalent seasonal influenza VLP vaccine candidate in healthy adults over age 60.

This randomized, double-blind, active-controlled study is evaluating the safety, tolerability and immunogenicity of two different doses of Novavax's trivalent seasonal influenza VLP vaccine compared with that of a commercially available trivalent inactivated vaccine Fluzone (TIV). Novavax's vaccine contains VLPs made up of the hemagglutinin, neuraminidase and matrix 1 proteins against the H3N2, H1N1 and B strains recommended for 2009-10 influenza vaccines.

Virus-like particles mimic the external structure of viruses but lack the live genetic material that causes viral replication and infection. VLPs can be designed quickly to match individual viral strains and be produced efficiently using portable cell-culture technology.

"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 CEO 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 [microgram] dose levels.

Seasonal flu infects between 5 percent and 20 percent of the world's population and kills 250,000 to 500,000 people each year. In the United States, the Centers for Disease Control and Prevention estimates that 15 million to 60 million people contract influenza each year leading to more than 200,000 hospitalizations and 36,000 deaths. The Advisory Committee on Immunization Practices recommends seasonal influenza vaccination for children 6 months through 18 years of age, pregnant women and adults over 50, and individuals of any age with chronic health conditions or who are at high risk of influenza disease.

Based on the expanding recommendation of vaccination to new age groups, the growing worldwide population to be vaccinated, and the need of an improved influenza vaccine for the elderly, global market projections of seasonal influenza are estimated to increase from $2.8 billion in 2007 to $6.5 billion by 2013.

Novavax is a clinical-stage biotechnology company. It has formed a joint venture with Cadila Pharmaceuticals named CPL Biologicals to develop and manufacture vaccines, biological therapeutics and diagnostics in India.