Novavax Presents Favorable Results from Phase I/IIa Pandemic Influenza Vaccine Program at World Health Organization ...( VLP Vaccine - Coupled with Innovative...),Health

VLP Vaccine - Coupled with Innovative Manufacturing - Has Potential to Address Gaps in Global Pandemic Preparedness

ROCKVILLE, Md., Feb. 17 /PRNewswire-FirstCall/ -- At the 5th World Health Organization Meeting on Evaluation of Pandemic Influenza Prototype Vaccines in Clinical Trials, Novavax, Inc. (Nasdaq: NVAX) announced favorable results from the second stage of the Phase I/IIa human clinical trial of its pandemic influenza virus-like particle (VLP) vaccine candidate. 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 VLP candidate is directed against the H5N1 A/Indonesia/05/2005 avian influenza strain. This strain of avian influenza emerged in humans in Indonesia in 2005 and has caused 135 documented cases, 81% of which have been fatal. (1)

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 15 micrograms (mcg), 45 mcg, or 90 mcg of vaccine or a placebo. The HAI titers to the vaccine strain increased with increasing doses. In the 90 mcg group, 63.6% of subjects achieved a four-fold or greater rise in HAI titers when compared to baseline and titers of at least forty (i.e., greater than or equal to 1:40). 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 proprietary 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 respons
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