QUEBEC CITY — Medicago Inc., a biotechnology company focused on developing vaccines based on proprietary manufacturing technologies and virus-like particles, reported positive interim results from a Phase I human clinical trial with its H5N1 avian influenza vaccine candidate.
The vaccine was found to be safe, well tolerated and also induced a solid immune response, Medicago announced Dec. 21.
"This trial was the first ever clinical evaluation of a plant-based Influenza VLP vaccine and shows that Medicago's vaccine is safe in humans," said Andy Sheldon, president and CEO of Medicago. "We believe our novel vaccine candidate, coupled with our rapid response and low cost manufacturing system offers a preferred option to increase the speed of a public health response in the event of a pandemic outbreak."
The Phase I study was designed to investigate the safety of the company's H5N1 alum-adjuvanted pandemic vaccine candidate and to provide an initial indication of the immune response.
A total of 48 healthy volunteers between the ages 18 to 60 received two doses of either Medicago's vaccine at doses of 5, 10 or 20 micrograms or a placebo. No serious adverse events were reported during the trial and the vaccine was found to be well tolerated at all three dose levels. Local site reactions were mild and the incidence of systemic side effects was comparable between the H5N1 vaccine groups and the placebo.
As planned in the initial design, adverse event monitoring will continue for six months after administration of the second vaccine dose.
The trial was conducted at the Vaccine Evaluation Center of McGill University in Montreal under the supervision of Dr. Brian Ward.
Preliminary results showed that 81 percent of immunized subjects developed an immune response against the H5N1 virus after the second immunization. Full results of this trial will be submitted for publication in a scientific journal and will be available in the coming months. Based on these results, Medicago will proceed with a Phase II clinical trial, expected to commence during the first half of 2010.
Medicago's H5N1 vaccine candidate was formulated to protect against the Indonesian influenza virus. It is manufactured in Nicotiana benthamiana, a relative of the tobacco plant, using the company's proprietary VLP technology.