Medicago begins phase I clinical trial of H1N1 vaccine

Medicago, a biotechnology firm focused on developing vaccines based on virus-like particles, recently announced that it has initiated clinical trials in the United States for its phase I H1N1 influenza VLP vaccine candidate.

Immunogenicity and primary safety results for the trial are expected to be ready within three months.

"We continue to make great strides in the clinical advancement of our vaccine candidates," Andy Sheldon, president and CEO of Medicago, said. “With the initiation of this clinical trial, we are in a good position to report multiple sets of data next quarter including data from this trial and final phase II data for our pandemic influenza candidate.”

The tolerability and immunogenicity of a single non-adjuvanted dose of H1N1 vaccine will be tested through the Phase I, multicenter, randomized, double-blind, active and controlled dose ranging study.

There will be 100 subjects used in the testing, ranging in age from 18 to 49. The subjects will randomly be given an injection of the placebo, Medicago’s H1N1 vaccine or an H1N1 vaccine from an already licensed trivalent vaccine.

“I am confident that the quality of data to be obtained from these clinical trials and our other solid results to date will further position Medicago as a leader in the development of rapid and cost-effective vaccines," Sheldon said.

Following the study, Medicago hopes to initiate a U.S. phase IIa trial for its seasonal trivalent vaccine with the H1N1, H3N2 and B influenza strains. The company intends to begin the trial later in 2011.