Novavax, Inc. has announced positive preclinical results with Novavax's 2009 novel H1N1 influenza virus-like particle (VLP) vaccine. The study, conducted by scientists from Novavax and the Centers for Disease Control and Prevention (CDC) based in Atlanta, GA, under a collaborative agreement, represents the first efficacy report of a 2009 novel H1N1 vaccine in ferrets. The ferret model is widely accepted to be the most appropriate animal model for evaluating influenza disease and vaccines. Novavax scientists designed the vaccine using recombinant virus like particles (VLP) technology against an H1N1 virus strain (A/California/04/2009) isolated in the beginning of the 2009 H1N1 outbreak.
Novavax produced the candidate vaccine and delivered it to the CDC in less than four (4) weeks from the day the genetic sequences of the virus strain became available. The speed at which this was accomplished is a testament to the fast response afforded by Novavax's proprietary, recombinant cell-based VLP technology which is not dependent on growing influenza virus in eggs and the development of virus seed stocks.
The Novavax VLP vaccine candidate protected ferrets against the 2009 novel H1N1 virus. The ferrets received a 3.75, 7.5, or 15.0 mcg dose of the 2009 H1N1 VLP vaccine or a placebo and were boosted with a second dose after three (3) weeks. All of the H1N1 VLP vaccinated animals, even in the lowest 3.75 mcg dose group, developed hemagglutination inhibition (HI) antibody titers of 1:40 or higher, considered a protective level of immunity, against the H1N1 virus. Remarkably, even after receiving a single dose of 7.5 or 15 mcg 2009 H1N1 VLPs, the animals developed an HI titer of 1:40 or higher against the H1N1 virus.