Medicago, a biopharmaceutical company focused on developing vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), has received clearance by Health Canada to initiate its phase II, dose-sparing clinical trial for an H5N1 Avian Influenza VLP vaccine candidate. All clinical lots have been produced and the trial will commence with interim results expected this summer.
"This trial follows on from our recent positive phase I interim results, which demonstrate that our vaccine candidate is, in our opinion, the best in class,” said Andy Sheldon, president and chief executive officer of Medicago. “In the face of a pandemic, it will be essential for governments to deploy an effective vaccine within their borders as quickly as possible."
Three clinical trials to date have been performed including 403 subjects. Medicago's H5N1 vaccine candidate was found to be safe and well-tolerated and induced a solid immune response. A U.S. phase I study was recently completed using a 20µg dose of the H5 VLP vaccine with or without the Alhydrogel (alum adjuvant) or the glucopyranosyl Lipid A (GLA-AF) adjuvant, given either intradermally (ID) or intramuscularly (IM). The results obtained revealed that all formulations were safe and well-tolerated and both alum and GLA induced antibody levels that met the three CHMP criteria for licensure of influenza vaccines.
The phase II, dose-sparing study is designed as a multi-center, observer blind, placebo-controlled study using the IM route of administration, with alum or GLA-based adjuvant in healthy adults 18 to 60 years of age. A total of 390 subjects will be randomized to receive two doses of the H5 VLP vaccine formulated with alum adjuvant or GLA-SE adjuvant or placebo.
The primary endpoints are immunogenicity evaluated 21 days after each administration as well as safety and tolerability after each administration and 12 months after the last injection. As a secondary endpoint, the immunogenicity and cross-reactive antibodies induced by the H5 VLP vaccine will be evaluated. The trial is anticipated to take 15 months to complete, with initial safety and immunology data expected this summer.