Medicago completes Phase II H5N1 vaccine trial

Canadian biotechnology company Medicago, Inc., which focuses on developing affordable and highly effective Virus-Like Particle vaccines, has announced the completion of the first part of its Phase II human clinical trial for an H5N1 avian influenza vaccine.

Medicago, Inc., finished this part of the trial by administering the final dose of vaccine to 255 healthy adults. It hopes to present interim Phase II clinical trial results with the H5N1 pandemic influenza vaccine in January 2011.

This Phase II placebo-controlled, randomized clinical trial is meant to evaluate the immunogenicity and safety of different doses of the company’s H5N1 vaccine. The adults in the study range in age from 18 to 60 years old.

The study involved injecting 135 of the adults with either a placebo or the H5N1 at varying doses. The second part of the trial, scheduled for 2011, will use the determined optimal dose of the vaccine or the placebo.

All recorded results have thus far shown the H5N1 vaccine to be safe and well tolerated.

“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.”

H5N1 has killed tens of millions of birds, with hundreds of millions slaughtered to limit the exposure of the disease. Hundreds of humans have also been killed by the potentially pathogenic disease.