Washington: IDRI (Infectious Disease Research Institute) and Medicago Inc. have reported positive interim results from a Phase I clinical trial for an H5N1 Avian Influenza VLP vaccine candidate ("H5N1 vaccine").
The results were announced at the World Vaccine Congress in Washington, DC.
The H5N1 vaccine was found to be safe and well-tolerated and induced a solid immune response exceeding the three CHMP (Committee for Medicinal Products for Human Use) immunogenicity criteria for licensure of influenza vaccines.
The vaccine was tested in three different configurations: using IDRI`s Glucopyranosyl Lipid A ("GLA") formulated adjuvant, given both intramuscularly and intradermally, and using alum intramuscularly. All three configurations exceeded the CHMP criteria.
IDRI is a Seattle-based non-profit research organization that is a leading developer of adjuvants used in vaccines combating infectious disease while Medicago Inc. is a biopharmaceutical company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs).
"These positive US clinical trial results confirm that our H5N1 vaccine candidate is the best in class in our opinion, positioning Medicago as a significant player in the global pandemic market. The robustness of our H5N1 vaccine coupled with our rapid speed of production, offers a vastly improved solution in preparing for and managing potential pandemics. We also believe that our H5N1 vaccine with alum is the only alum-adjuvanted pandemic vaccine to achieve the three CHMP immunogenicity criteria," said Andy Sheldon, President and CEO of Medicago.
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 and 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," he added.