Palese’s laboratory is one of three different research groups at Mount Sinai exploring a universal flu vaccine and one of numerous efforts underway mostly in academia, biotech firms and NIH. A handful of major pharmaceutical companies are supporting universal flu vaccine research, including GlaxoSmithKline, Janssen Vaccines, a division of Johnson & Johnson, and Sanofi.
Palese’s team has developed a universal flu vaccine that is now in the first phase of testing in humans, with support from GSK and the Gates Foundation. “What changes in the influenza virus from year to year is the hemagglutinin (HA),” Palese explained, “which is the major protein against which we make an immune response.”
The HA comprises a head and a stalk. “When our immune system sees a flu virus, it makes antibodies against the head,” he said. Palese’s vaccine aims to stimulate antibodies that bind to the more “conserved” areas on the stalk and which remain the same every year and are common to most seasonal flu viruses. “We want to redirect the body’s immune response to the stalk.”
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A different approach to the universal vaccine is underway at FluGen, a biotech firm in Madison, Wis. Backed by both government and VC funding, the company is working with technology first discovered at the University of Wisconsin-Madison by Dr. Yoshihiro Kawaoka and Dr. Gabriele Neumann and exclusively licensed to FluGen. “Our vaccine, called RedeeFlu, is based on a premise that says, what happens if you take a [naturally occurring] ‘wild-type’ of flu virus and modify it to infect the human body but don’t allow it to replicate and cause illness?” said Boyd Clarke, executive chairman of FluGen. (Coincidentally, his maternal grandfather died in the 1918 flu pandemic.)
Last October, FluGen announced that it was awarded $14.4 million by the Department of Defense to conduct human clinical challenge trials with RedeeFlu. In those studies, half of the participants will be vaccinated and half will receive a placebo, but all will subsequently be infected with an influenza virus. “We want to see if the vaccine prevents illness and replication of the virus,” Clarke said. “Based on pre-clinical trials, we have reason to be optimistic.”
On another front, this year the Human Vaccines Project, a New York-based non-profit consortium of academic, government and industry medical researchers, is launching the Universal Influenza Vaccine Initiative (UIVI). “The goal is to understand immunity to the flu and then convert that into a universal flu vaccine,” said Dr. James Crowe, a pediatric infectious diseases physician at Vanderbilt University Medical Center in Nashville, Ten., and the director of UIVI. Similar to Palese’s approach, UIVI is targeting the more stable stalk region of the HA protein.
Although Crowe is dedicated to the eventual discovery of a universal vaccine, he also wants to focus on improving current vaccines. “The excitement in the field is making better vaccines for strains that are killing people right now,” he said. “Even modest improvements would save thousands of lives.”