Novavax reports encouraging results from Phase I/IIa influenza vaccine trial

The vaccine, which does not contain an adjuvant, induced robust hemagglutination inhibition (HAI) responses, which have been shown to be important for protection against influenza disease. Novavax’s virus-like particle (VLP) candidate is directed against the H5N1 A/Indonesia/05/2005 avian influenza strain.

In this study, the vaccine demonstrated strong HAI antibody titers against the H5N1 A/Indonesia strain. The study evaluated individuals from 18 to 40 years of age who received two injections of 15mcg, 45mcg, or 90mcg of vaccine or a placebo. The HAI titers to the vaccine strain increased with increasing doses. In the 90mcg group, 63.6% of subjects achieved a four-fold or greater rise in HAI titers when compared to baseline and titers of at least 40, the company said.

According to the company, all subjects tested negative for antibodies to the H5N1 A/Indonesia strain before vaccination and no responses were observed among individuals who received a placebo.

Novavax’s VLPs contain the surface proteins (hemagglutinin [HA] and neuraminidase [NA]) and matrix protein (M1) of the H5N1 A/Indonesia strain. Additional immunological responses induced by the other components of the vaccine are being evaluated, including responses against the NA and M1 proteins.

Rahul Singhvi, president and CEO of Novavax, said: These data, coupled with the strong neutralizing antibody titer data from this study disclosed in 2008, demonstrate that the Novavax recombinant VLP vaccine is a valid and potent approach against pandemic influenza. This vaccine and our innovative manufacturing approach have the potential to address an unmet need in pandemic influenza preparedness efforts being planned by health authorities around the world.