Medicago's H5N1 pandemic flu vaccine effective in key ferret animal model with single dose
Medicago Inc. 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. Results demonstrated that a single 5-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 European Union Committee for Medicinal Products for Human Use (CHMP). These criteria set by the CHMP for the approval of seasonal flu vaccines in the European Union 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.
"We believe these results are highly convincing as we prepare to commence human clinical trials for our vaccine," said Andy Sheldon, President and CEO of Medicago. "Our VLP vaccine is one of the first pandemic influenza vaccines to demonstrate it may provide significant immune protection after a single dose."
"Ferrets are the gold standard for determining the immunogenicity and efficacy of a vaccine candidate prior to human clinical trials," said Nathalie Landry, Medicago's VP Product Development. "FDA-approved H5N1 influenza vaccines in the United States require two 90-microgram doses, administered at least four weeks apart to achieve appropriate level of antibodies in 44% of vaccinated individuals. If these ferrets' results replicate in human clinical trials, we believe that our vaccine will have the potential to generate protection levels after just one dose of vaccine."
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 5 to 15 micrograms met all CHMP criteria after the first dose with 100% of the ferrets having an hemagglutination inhibition (HAI) titer greater than 1:40. In addition, all ferrets vaccinated with lower doses of 1 (micro)g met the three CHMP criteria after two doses.
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Topic world Antibodies
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