Novavax reports data for H7N9 avian flu vaccine

Novavax Inc. (NASDAQ:NVAX) reported safety and immunogenicity data on Wednesday from a Phase I trial evaluating its H7N9 VLP influenza vaccine in 284 healthy adult volunteers -- the first human data for an H7N9 avian flu vaccine. In the adjuvanted arms, seroconversion rates -- defined as a four-fold increase in hemagglutinin inhibition (HAI) titer from baseline -- at day 35 were 64.9% for low-dose vaccine with low-dose adjuvant; 36.8% for high-dose vaccine with low-dose adjuvant; 80.6% for low-dose vaccine with high-dose adjuvant; and 64.7% for high-dose vaccine with high-dose adjuvant. Subjects received two doses of 15 or 45 ug intramuscular H7N9 VLP vaccine given 21 days apart without adjuvant; two doses of 5 or 15 ug intramuscular H7N9 VLP vaccine given 21 days apart with a low- or high-dose saponin-based Iscomatrix adjuvant from CSL Ltd. (ASX:CSL); or placebo. The vaccine was generally well tolerated with no treatment-related serious adverse events reported. Data were published in the correspondence section of the New England Journal of Medicine.

Next quarter, Novavax plans to start a Phase II trial with the H7N9 VLP vaccine to evaluate a larger range of antigen/adjuvant dose combinations. Immunogenicity data are expected in 3Q14. The company said it took less than four months after the H7N9 virus was identified and sequenced to achieve protective immune responses with a recombinant vaccine. The vaccine to prevent H7N9 influenza uses recombinant virus-like particle (VLP) technology. ...