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IDRI and Medicago report positive results for Phase I clinical trial for an H5N1 vaccine
Date:4/17/2013

tive and capital inexpensive system we are perfectly poised to obtain this objective. In summary, all three configurations tested of the H5N1 vaccine meet the CHMP criteria for licensure, placing us in a strong position with multiple product options. We will further investigate the use of alum and formulated GLA in a Phase II trial to be initiated in May 2013 with results expected in Q3 2013."

The trial results also underscore IDRI's leadership position in the field of adjuvants, with a focus on developing products that will reduce the burden of global infectious disease. "This study design and results demonstrate the potential for significant 'dose-sparing' -- increasing the number of available doses by reducing the amount of vaccine needed per individual, in a simple to administer format," said Dr. Steven Reed, IDRI Founder, President and Chief Scientific Officer, who presented the trial results at the World Vaccine Congress, along with Dr. Brian Ward, Professor of Medicine & Microbiology, McGill University, member of Medicago's scientific advisory committee and Medical Officer. "This H5N1 vaccine candidate represents the next generation of flu vaccines, combining our adjuvant technology with Medicago's rapid VLP technology and the intradermal delivery device from NanoPass."

Study Design

The Phase I clinical trial, which commenced in September 2012, enrolled 100 healthy adult volunteers, aged 18-49 years, at three locations in the U.S., testing for safety and immune response. The vaccine was also tested in comparison to Medicago's H5N1 vaccine with alum. The trial is funded by a multi-million dollar grant IDRI received from the Defense Advanced Research Projects Agency (DARPA), a division of the United States Department of Defense, to investigate the safety and immunogenicity of a novel adjuvant with a Nicotiana benthamiana produced vaccine candidate. Each study participant in the trial received two doses of a given formulation in
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Contact: Lee Schoentrup
lee.schoentrup@idri.org
206-858-6064
Infectious Disease Research Institute
Source:Eurekalert

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