Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The Infectious Disease Research Institute (IDRI) and Medicago will initiate a Phase 1 clinical trial for an H5N1 Avian Influenza VLP vaccine candidate ("H5N1 vaccine") following the approval of US Food and Drug Administration (FDA).
Subscribe to our email newsletter
The trial will evaluate the safety and immunogenicity of the H5N1 vaccine, combined with IDRI’s Glucopyranosyl Lipid A ("GLA") adjuvant.
Each study participant in the trial will receive two doses of a given formulation in order to collect and compare data.
IDRI Adjuvant Technology program vice president and project co-principal investigator Darrick Carter said, "Our idea is to ultimately produce a one-dose vaccine that you could give yourself – imagine a flu vaccine that you can easily administer using a simple, painless microneedle device arriving in your mailbox."
Medicago president and chief executive officer Andy Sheldon said Medicago views the collaboration with IDRI on this important initiative as a testament to the quality and efficacy of H5N1 Influenza VLP vaccine.
”We look forward to now combining our vaccine candidate with IDRI’s adjuvant and the microneedle technology,” Sheldon added.
IDRI president, founder and chief scientific officer and project co-principal investigator Steven Reed said the predicted efficacy of a pandemic influenza vaccine is directly related to three components such as the nature of the vaccine, the way the vaccine is administered and the presence or absence of a given adjuvant.
”Combining our adjuvant technology with Medicago’s rapid VLP technology is key to the next generation of flu vaccines, as well as an innovative delivery method from NanoPass," Reed added.
The 15 month phase 1 clinical trial is expected to start in September 2012 and will enroll 100 volunteers at three locations in the US to test safety and immune response.
The trial will test the traditional intramuscular route of delivery for comparison purposes while NanoPass proprietary MicronJet600 microneedle device will test the intradermal route.
NanoPass chief executive officer Yotam Levin said, "Intradermal injection may have advantages over the intramuscular route in that the injection is painless, needle-free, and potentially more immunogenic as it provides targeted delivery of the vaccine to specialized cells of the immune system."