Medicago Inc., a biotechnology company in Quebec City, Canada has begun a phase I clinical trial of its H1N1 influenza vaccine candidate in the United States. The trial tests the drug’s safety, tolerability, and capacity to induce an immune response, with results expected in three months.
The randomized, double-blind, multicenter, active- and placebo-controlled dose-ranging study will evaluate a single dose of the H1N1 vaccine in 100 healthy adults 18-49 years of age. The subjects will be randomized to receive one of the following; an injection of the placebo, Medicago’s H1N1 vaccine, or an H1N1 vaccine from a licensed trivalent vaccine.
Earlier this month, the World Health Organization and the U.S. Food and Drug Administration decided on the composition of the trivalent influenza virus vaccine that will be used during the 2010-2011 season in the northern hemisphere. This phase I trial is expected to lead to Medicago’s next (phase 2a) trial in the U.S. for its seasonal trivalent vaccine with the recommended H1N1, H3N2, and B influenza strains, planned for later in 2011.
The U.S. Centers for Disease Control and Prevention (CDC) recommends preventing seasonal flu by getting a seasonal flu vaccination each year. According to CDC, each year in the United States on average, 5 to 20 percent of the population gets the flu; on average, more than 200,000 people are hospitalized from flu-related complications, and; about 36,000 people die from flu-related causes.
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