One of the worst fears of public health officials is that a new flu strain could emerge, sweeping the world and killing millions of people, like the notorious “Spanish flu” pandemic of 1918. Now the Seattle-based Infectious Disease Research Institute and a Canadian biotech company are working on testing a flu vaccine candidate that people could inject themselves in a hurry if a similar outbreak were to occur.
IDRI and Quebec City, Canada-based Medicago said today that they have gotten clearance from the FDA to start clinical trials of a vaccine against the H5N1 form of influenza, sometimes called avian flu or “bird” flu.
The vaccine candidate brings technology together to speed up manufacturing, and to get the maximum antiviral protection possible at low doses. The vaccine candidate from Medicago creates virus-like particles in a plant-based manufacturing system that’s supposed to be faster and more efficient than the traditional egg-based system that flu vaccine manufacturers depend on today. IDRI’s role is to help increase the effectiveness of the vaccine with a synthetic immune-boosting compound called an adjuvant. The adjuvant is a key ingredient because it could allow manufacturers to pump out millions of small, but effective, doses that would make it possible to combat an epidemic without investing lots of time and money in new vaccine factories.
The vaccine candidate has also been designed to be given as a traditional injection into the muscle, or possibly just into the skin. That could be the most novel feature of such a vaccine, as IDRI said in today’s statement that an “intradermal” vaccine candidate could make it possible for people to inject themselves at home. If a really dangerous flu pandemic struck, an intradermal vaccine could save people from having to wait in line at healthcare providers who would likely be overwhelmed by panicky people trying to get vaccinated before they get exposed to the virus.
“A massive flu outbreak would cause a strain on health care centers as people rush to get a vaccination,” said Darrick Carter, vice president of IDRI’s adjuvant technology program and co-principal investigator for the project, in a statement. “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.”
The clinical trial is expected to enroll 100 healthy adult volunteers at three sites in the U.S. starting in September, with the first set of safety data expected to be available before the end of March 2013, IDRI and Medicago said in a statement.
If this trial is successful, it could help IDRI extend the use of its adjuvant into other vaccines. The nonprofit said in May it formed a partnership with Rockville, MD-based Aeras to use its adjuvant as part of a new tuberculosis vaccine candidate being prepped for clinical trials.