H5N1 vaccine enters Phase II human clinical trials

Health Canada has recently cleared the biopharmaceutical company Medicago, Inc., to begin Phase II human clinical trials of its H5N1 avian influenza vaccine.

The Phase II trials will be randomized and placebo controlled and focused on evaluating the immunogenicity of different doses of the H5N1 vaccine. A total of 225 healthy adults between the ages of 18 and 60 will participate in the trials.

In the beginning of the study, healthy adults will be injected with either a placebo or the H5N1 vaccine at varying doses as part of an effort to determine an optimal dose. In the study’s second portion, healthy adults will then be given either the optimal dose or the placebo. Interim results of these parts of the study are expected in less than three months.

"The initiation of our Phase II clinical trial is an important step in the development of our plant-based VLP vaccines, which we believe are highly effective, cross-protective, less expensive and faster to produce than current influenza vaccines," Andy Sheldon, President and CEO of Medicago, said. "It also demonstrates our ability to advance candidates through clinical development.

"Our platform is very versatile and to date, we have been able to produce a broad array of other proteins with potential use in the life science industry. This clinical trial therefore provides additional validation for our rapid and cost-effective technology platform offering."