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news.Medicago has announced positive results from a preclinical immunogenicity study of the company's H5N1 avian influenza VLP vaccine that was performed in ferrets, the most predictive animal model for the effectiveness of influenza vaccines in humans.
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Results demonstrated that a single five microgram dose of the company’s H5N1 VLP vaccine induced high levels of antibodies in 100% of ferrets and met all required immunogenicity criteria of the EU Committee for Medicinal Products for Human Use (CHMP). These criteria set by the CHMP for the approval of seasonal flu vaccines in the EU are widely used to assess immune responses of new pandemic influenza vaccines in humans. In the case of ferrets, these criteria are useful to predict effective doses that should be tested in humans.
The objective of Medicago’s study was to determine the optimal dosage of its VLP vaccine in ferrets. At the start of the study, ferrets were vaccinated with a range of doses of the company’s VLP vaccine made from an Indonesian strain of H5N1 avian influenza. A booster immunization was administered after three weeks.
The results demonstrated that ferrets vaccinated with doses ranging from five to 15 micrograms met all CHMP criteria after the first dose, with 100% of the ferrets having an hemagglutination inhibition titer greater than 1:40. In addition, all ferrets vaccinated with lower doses of one microgram met the three CHMP criteria after two doses.
Andy Sheldon, president and CEO of Medicago, said: “We believe these results are highly convincing as we prepare to commence human clinical trials for our vaccine. Our VLP vaccine is one of the first pandemic influenza vaccines to demonstrate it may provide significant immune protection after a single dose.”