Novavax Reports Positive Results from Preclinical Studies of its VLP-based Trivalent Seasonal Influenza Vaccine Candidate

May 8, 2008
BioPharm International Editors

Novavax, Inc. (Rockville, MD) has received positive results from an immunogenicity study in ferrets inoculated with the company’s trivalent seasonal influenza vaccine candidate made using its proprietary virus-like particle (VLP) technology.

Novavax, Inc. (Rockville, MD) has received positive results from an immunogenicity study in ferrets inoculated with the company’s trivalent seasonal influenza vaccine candidate made using its proprietary virus-like particle (VLP) technology. These findings will enable Novavax to complete its planned investigational new drug (IND) application to support initiation of a Phase 2 clinical trial targeted to begin in the third quarter of this year.

VLPs may have a number of advantages over traditional vaccines. Because VLPs more closely match an individual viral strain, they can trigger a more robust immune response. In addition, live virus is not needed to produce a VLP vaccine. Only the genetic sequence of a virus is needed to create a VLP vaccine against it.

In the study, ferrets were inoculated with the company's trivalent seasonal influenza vaccine containing a mixture of three VLPs representing the H3N2, H1N1, and B virus strains. The vaccine induced protective antibody levels against each of the three strains represented in the vaccine in 100% of ferrets receiving a dose of 15 mcg/strain, which is the standard dose for currently licensed split and subunit influenza vaccines. The vaccine candidate also induced protective antibody titers against a drifted strain in approximately 50% of ferrets inoculated.

The company is also preparing its seasonal VLP vaccine candidate for head-to-head human studies against a marketed flu vaccine beginning in the fourth quarter of 2008. Virus-like particles have been created for each of the three new flu vaccine strains recommended by the Centers for Disease Control and Prevention (CDC) for the upcoming 2008-2009 season. It is not common for the CDC to recommend changing all three strains of the seasonal influenza vaccine, however, even with this recommendation, Novavax has been able to construct the corresponding VLPs within six weeks of the announcement.

Novavax release (PDF)

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