Flu vaccine trial yields positive results, Novavax says

ROCKVILLE, Md. A clinical trial of a seasonal influenza vaccine that began in May 2009 has produced positive results, the vaccine’s developer announced.

Novavax said new data from a trial of its virus-like particle vaccine in patients ages 18 to 49 years showed the vaccine matched the influenza strains for which vaccination was recommended for the 2008-2009 influenza season. The study enrolled 241 subjects, of whom 221 were randomized to receive either the vaccine or placebo and 20 who received a conventional flu vaccine.

In an evaluation of the study, Novavax tested volunteers for immune response to the H3N2/Brisbane and B/Florida strains before and after immunization, finding that 50% to 73% of those immunized with Novavax’s vaccine had a fourfold increase in the antibody against neuraminidase, an enzyme that helps the virus replicate, compared with 1-of-19 volunteers who received a conventional flu vaccine and none who received placebo.

“These are very exciting results which not only support continued development of novel VLP vaccines against influenza but also provides a cornerstone to potentially differentiate our vaccine from the current standard of care,” Novavax president and CEO Rahul Singhvi said.

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