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news.Novavax has received positive results from an immunogenicity study in ferrets inoculated with the company's trivalent seasonal influenza vaccine candidate. These findings will enable the company to complete its planned investigational new drug application to start Phase II clinical trial targeted to begin in the third quarter of 2008.
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In the study, ferrets were inoculated with the company’s trivalent seasonal influenza vaccine containing a mixture of three virus-like particles (VLPs) representing the H3N1, H1N1 and B virus strains. The vaccine induced protective antibody levels against each of the three strains represented in the vaccine in 100% of ferrets receiving a dose of 15mcg/strain which is the standard dose for currently licensed split and subunit influenza vaccines.
The vaccine candidate also induced protective antibody titers against a drifted strain in approximately 50% of ferrets inoculated. A separate toxicology study conducted in rabbits showed that the trivalent vaccine was well tolerated with no unexpected side effects.
Penny Heaton, Novavax’s chief medical officer and vice president of development, said: “In addition to the positive results from our seasonal influenza vaccine candidate announced today, the dose-ranging study of our H5N1 pandemic flu vaccine is enrolling as projected based on the favorable interim safety and immunogenicity analyses conducted last December. We plan to have the final doses selected for late stage development for both the pandemic and seasonal flu vaccine programs by the second half of 2008.”