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Novavax's Seasonal Influenza VLP Vaccine Candidate Shows Positive Results in a Phase II Clinical Trial in Older Adults
Date:4/29/2010

ROCKVILLE, Md., April 29 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX) reported today that its trivalent seasonal influenza virus-like-particle (VLP)-based vaccine candidate was safe and immunogenic against the 2009-2010 seasonal influenza virus strains in older adults 60 years or higher in age.

In a double-blind, active-controlled Phase II study of 480 randomized subjects, the safety, tolerability and immunogenicity of a single 15 microgram dose or 60 microgram dose (per strain) of trivalent influenza VLP was compared to a dose of a commercially available inactivated trivalent influenza vaccine (TIV). The primary immunogenicity measure in the study was hemagglutination inhibition (HAI) antibody response induced by the vaccine 21 days after immunization.  At both the high (60 microgram) and low (15 microgram) dose, the VLP vaccine showed no significant increase in severe local or systemic adverse events.  

While the study was not powered to obtain definitive differences in immunogenicity between VLP doses or establish non-inferiority between VLPs and TIV, a preliminary analysis of immunogenicity results showed that the 60 microgram dose of trivalent VLP vaccine induced a statistically significant higher seroconversion rate than TIV against one of the three 2009-2010 strains of seasonal influenza virus and showed no statistically significant difference from TIV in the seroconversion rate against the other two strains.  The 15 microgram dose of trivalent VLP vaccine did not induce significantly different seroconversion rates than TIV for two of the three strains, but induced a significantly lower seroconversion rate compared to TIV against one of the strains.

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SOURCE Novavax, Inc.
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