Medicago Inc., a biotechnology company focused on developing highly effective and affordable vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today announced that the last dose of vaccine has been administered completing the first part of the Company’s Phase II human clinical trial with its H5N1 Avian Influenza vaccine (“H5N1 vaccine”). The Company expects to present interim Phase II clinical trial results with its H5N1 pandemic influenza vaccine in January, 2011.
The Phase II randomized, placebo controlled clinical trial is designed to evaluate the safety and immunogenicity of different doses of the Company’s H5N1 vaccine. Specifically, the vaccine will be studied in approximately 255 healthy adults between the ages of 18 to 60 years.
In the first part of the study conducted in 2010, 135 healthy adults were administered twice with either a placebo or the H5N1 vaccine at varying doses to determine the optimal dose.
In the second part of the study to be conducted in 2011, healthy adults will receive an injection of either a placebo or the H5N1 vaccine at the optimal dose. To date, all results have shown the H5N1 vaccine is safe and well tolerated.
Source : Medicago Inc.