Novavax Completes Enrollment In Phase IIa Study Of Seasonal Influenza Vaccine

Novavax has completed enrollment in the Phase II clinical study of its trivalent seasonal influenza (2008/2009 recommended strains) VLP vaccine candidate in healthy adults 60 years of age or older (older adults).

The randomised, double-blind, active-controlled study is comparing the safety, tolerability and immunogenicity of two different doses (15mcg and 60mcg) of Novavax’s trivalent seasonal influenza VLP vaccine to a commercially available trivalent inactivated vaccine, TIV (Fluzone).

The study enrolled 467 older adults in a three-arm study at six different sites located within the US. In addition to evaluating hemagglutinin inhibition (HAI) 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 (NAI) antibody titers and T-cell responses, indicating the potential for broader immunologic responses particularly in older adults.

Rahul Singhvi, president and chief executive officer of Novavax, said: “With the rapid completion of enrollment in this clinical trial as well as the first part of our H1N1 vaccine study in Mexico announced previously, we are on track to report results from our two most advanced clinical programs during the first quarter of next year.

“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.”