Novavax, Inc. (NVAX) announced favorable initial results from the first stage of a two-stage pivotal Phase II study evaluating the safety and immunogenicity of the company's 2009 H1N1 virus-like particle, or VLP, pandemic influenza vaccine.
In Stage A of Phase II study, one thousand healthy volunteers aged 18 to 64 years old were enrolled to receive two doses of 5 mcg, 15 mcg or 45 mcg of company's 2009 H1N1 pandemic influenza VLP or a placebo to determine the safety and immunogenicity of the vaccine. The Independent Data and Safety Monitoring Board, or DSMB, reviewed preliminary safety and immunogenicity data 14 days post dose one from a subset of approximately 500 subjects enrolled in this stage of the trial. The vaccine was found to be well tolerated at all three dose levels and exhibited no systemic side effects in this review period.
The company noted that in the subset of 500 subjects from Stage A, the hemagglutinin inhibition antibody titers 14 days post dose one in the 15 and 45 mcg arms met the seroconversion and seroprotection criteria recommended by the U.S. and European regulatory authorities. Based on these findings, the DSMB recommended that the study proceed to Stage B of testing in which vaccine safety will be evaluated in 3 thousand subjects with a 15 mcg single dose regimen.
The safety and immunogenicity data from all one thousand subjects in Stage A will be available in January, 2010.
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