22 Apr 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Vaccine development company Medicago and Infectious Disease Research Institute (IDRI), US, reported positive interim results from a phase I clinical trial for an H5N1 Avian Influenza VLP vaccine candidate.
The vaccine was tested in three different configurations, using IDRI's Glucopyranosyl Lipid A formulated adjuvant, given both intramuscularly and intradermally, and using alum intramuscularly. All three configurations exceeded the CHMP criteria.
"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 Mr Andy Sheldon, president and CEO, Medicago.
"Moreover, the combination of our vaccine candidate with IDRI's adjuvant generated a robust immune response. In the case of a pandemic, governments will require the rapid development of an effective vaccine within their borders to conquer the spread of the virus, with our cost-effective and capital inexpensive system we are perfectly poised to obtain this objective," he said.
"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," Mr Sheldon added.