Novavax, a biotechnology company, has reported vaccination of healthy volunteers in the second clinical trial of its virus-like particle or VLP seasonal influenza vaccine.
Building on data from the first study, this Phase II randomized, placebo controlled clinical trial has been designed to evaluate the safety and immunogenicity of a broader range of vaccine doses. The purpose of this study is to provide data to help with selecting doses for future studies in older adults and a Phase III efficacy study.
Specifically, the trivalent seasonal vaccine containing VLPs against the 2008-2009 H3N2, H1N1, and B influenza strains will be studied in approximately 220 healthy adults between the ages of 18 to 49 years, who will receive a single injection of either a placebo or influenza vaccine at doses of 15mcg or 60mcg.
The current study was planned before the recent outbreak of the 2009 H1N1 influenza virus in North America, which has since spread around the globe. In response to the outbreak, Novavax is making a VLP vaccine candidate against the outbreak strain.
Using Novavax’s recombinant technology, the VLPs will be genetically matched to the H1N1 influenza strain recommended by Center for Disease Control, with the potential to induce specific and protective immunity. Further, the VLP approach has the potential of a rapid response as vaccine may be made and released for administration within 12 weeks of knowing the genetic sequence of the outbreak strain, said Novavax.
Rahul Singhvi, president and CEO of Novavax, said: The initiation of this study of the 2008-2009 VLP vaccine highlights our ability to create and manufacture VLPs against multiple influenza strains. Including this study, we now have created and evaluated the safety and immunogenicity of VLPs against seven different strains of influenza in clinical trials. This experience has been of great value as we continue our efforts to create a VLP vaccine against the recently emerged 2009 H1N1 influenza virus.