The Infectious Disease Research Institute or IDRI, a Seattle-based non-profit research organization, and Medicago Inc. (MDG.TO: Quote,MDCGF.PK) announce that they have been cleared by the U.S. Food and Drug Administration or FDA to initiate a Phase 1 clinical trial for an H5N1 Avian Influenza Virus-Like Particles vaccine candidate or "H5N1 vaccine".
The IDRI said that the trial is focused on evaluating the safety and immunogenicity of the H5N1 vaccine, combined with IDRI's Glucopyranosyl Lipid A or "GLA" adjuvant, which will be administered intramuscularly or intradermally. Each study participant in the trial will receive two doses of a given formulation in order to collect and compare data.
The H5N1 vaccine candidate includes IDRI's GLA adjuvant and is produced in Medicago's plant-based expression system, which is speedier than the traditional route of producing flu vaccines in eggs.
The IDRI said it expects that the Phase 1 clinical trial will start in September 2012, and will enroll 100 healthy adult volunteers, ages 18-49 years, at three locations in the U.S., testing for safety and immune response. The trial is anticipated to take 15 months to complete, and initial safety and immunology data are expected in the first quarter of 2013.
It is funded by a multi-million dollar grant IDRI received from the Defense Advanced Research Projects Agency or DARPA, a division of the United States Department of Defense, to develop an influenza vaccine for pandemic flu.
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by RTT Staff Writer
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