Novavax has announced positive preclinical trial results for its H1N1 influenza virus-like particle (VLP) vaccine.
The study, conducted in conjunction with the US Centers for Disease Control and Prevention represents the first efficacy report of a 2009 novel H1N1 vaccine in ferrets, the animal model considered most appropriate for evaluating influenza disease and vaccines.
Novavax developed the vaccine drawn from the H1N1 strain using proprietary, recombinant cell-based VLP technology which is not dependent on growing influenza virus in eggs and the development of virus seed stocks.
All the ferrets used in the trial that received a 3.75, 7.5 or 15mcg dose of the 2009 H1N1 VLP vaccine or a placebo developed hemagglutination inhibition (HI) antibody levels, considered as a protective level of immunity, against the H1N1 virus.
Novavax vice-president of vaccine development Dr Gale Smith said that demonstrating that the influenza VLP vaccine candidate protects against the pandemic H1N1 virus in an animal model is another important milestone.
Vaccinated animals were also challenged with nasal exposure to the live H1N1 A/Mexico/4482/2009 (MX/4482) influenza virus strain that was distinct from the H1N1 A/California/04/2009 strain against which the vaccine was derived, also showing strong results.
"An even broader significance of this study is that these data, for the first time, indicate that a vaccine against the H1N1 A/California/04/2009 influenza strain has the potential to protect against the 2009 pandemic H1N1 virus," Smith said.