Seattle's Infectious Disease Research Institute is cleared to begin clinical trials for a do-it-yourself, needle-free vaccine for avian influenza and for a four-part vaccine for tuberculosis.
Remember how the swine-flu scare in late 2009 prompted thousands of people in the Puget Sound area to wait in line for hours to get a flu shot?
What if, instead, they could get their flu vaccine in the mail, packaged with a little device that would allow them painlessly to give themselves a dose that was short on actual vaccine but long on effectiveness?
That’s the goal of Seattle’s Infectious Disease Research Institute (IDRI), which has just received approval from the U.S. Food and Drug Administration (FDA) to start a Phase I clinical trial for an avian-influenza vaccine that’s combined with something called an adjuvant, which strengthens the immune response, and is delivered through a skin-pricking device that uses tiny micro-needles.
Darrick Carter, vice president of IDRI’s adjuvant-technology program and co-principal investigator for the project, said the federal government is well aware that the demands for vaccine during the swine-flu scare nearly overwhelmed the public-health system.
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“We were already in the orange zone,” he said. If a deadly pandemic were to hit, “they think the whole system might collapse.”
Being able to quickly produce a vaccine which could be delivered through the mail and self-administered, and which would use adjuvants to enhance immune response, was very attractive to the government, Carter said. It funded the project through a division of the Department of Defense.
Trial starts next month
The trial, which will enroll 100 people in Florida, Texas and Wisconsin, will begin in September to test the vaccine’s safety and immune response.
Getting to the clinical-trial stage was a three-company effort. IDRI developed the adjuvant, which allows much less vaccine to be used per dose — important if a pandemic flu caused vaccine to be in short supply.
Medicago, a Canadian biopharma company, developed a plant-based method to manufacture the vaccine, sidestepping the traditional egg-based method, which is difficult to quickly scale up or change as a virus mutates.
Medigago uses a relative of the tobacco plant to produce “virus-like particles” that mimic the virus and produce an immune response in the human body. Using the genetic sequence of the virus, the company says it can produce a vaccine in as few as 14 days, compared with a typical six-month turnaround in eggs. Because there already is extensive experience with tobacco plants, the costs of cultivation, scale-up and maintenance are relatively low, Medicago says.
The third company, NanoPass, located in Israel, developed the MicronJet600, a device that is essentially needle-free. It works through an intradermal route, getting the vaccine into the skin instead of into a muscle. Unlike the typical intramuscular flu-shot method, it wouldn’t require special training to administer, Carter said.
NanoPass’s CEO, Dr. Yotam Levin, said in an email that earlier tests have showed intradermal delivery is particularly effective with vaccines, “since it utilizes the special immunity of the skin to generate such a response.”
TB vaccine test
Wednesday, IDRI announced it had also been approved for a Phase I trial to test safety and immune response of its new tuberculosis vaccine candidate.
The vaccine will target both active TB, which sickens an estimated 9 million people each year, and latent TB, carried by an estimated one-third of the world’s population.
While people with latent TB cannot infect others, if their immune systems become compromised, the disease can become active and infectious.
Rhea Coler, a vice president at IDRI and principal investigator of the TB trial, said the vaccine contains components that hit the TB bacterium at four different stages of development. The trial plans to enroll 60 volunteers in Kansas, and about 15 already have signed up, Coler said.
“Seeing products move from lab bench to trial is a dream come true for a scientist,” she added.
The TB trial is one of several funded by Aeras, a nonprofit organization that receives funding from the Bill & Melinda Gates Foundation, other private foundations and a wide range of governments. It is based in Maryland and in Cape Town, South Africa.
Carol M. Ostrom: 206-464-2249 or email@example.com. On Twitter @costrom.