Novavax completes enrollment in study of seasonal flu vaccine in older adults

ROCKVILLE, Md. — Novavax announced Nov. 30 that it has completed enrollment in the Phase II clinical study of its trivalent seasonal influenza virus-like particle vaccine candidate in healthy adults 60 years of age or older.

This study is comparing the safety, tolerability and immunogenicity of two doses (15 micrograms and 60 mcg) of Novavax's trivalent seasonal influenza VLP vaccine to a commercially available trivalent inactivated vaccine, TIV (Fluzone).

This study enrolled 467 older adults in a three-part study at six sites in the United States.

In addition to evaluating hemagglutinin inhibition responses, anti-neuraminidase and cell-mediated immune responses are also being examined. Previous studies have shown that VLP-based flu vaccines drive strong neuraminidase inhibition antibody titers and T-cell responses, indicating the potential for broader immunologic responses particularly in older adults.

"If results from the seasonal flu vaccine study are positive, we will be able to advance this program into Phase III clinical testing as early as 2010," said Dr. Rahul Singhvi, president and CEO of Novavax.

Virus-like particles, VLPs, 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.