250 Here Sought for Tests of Bird Flu Vaccine

March 22, 2006

Vaccine experts in Rochester are looking for 250 people willing to roll up their sleeves and take part in one of two research studies of an experimental bird flu vaccine.

The work at the University of Rochester Medical Center is the next step in the effort to develop a vaccine that could be used to prevent bird flu, should the disease acquire the ability to spread from person to person.

The University’s Vaccine and Treatment Evaluation Unit is beginning two new research studies of a vaccine made by Sanofi Pasteur that has been shown to be safe in previous studies. Investigators need participation from 150 healthy people between the ages of 18 and 49 from the Rochester area for the first study; for the second study, 100 people 65 and older are sought. Rochester is one of several sites around the nation taking part in the two studies.

Each volunteer will receive two flu shots, one month apart, and will have their blood tested so that researchers can determine whether the shots bring about an immune response sufficient to protect from bird flu. A key feature of the research studies is the use of an “adjuvant,” a substance designed to boost the immune response of a vaccine. In this experiment an adjuvant known as aluminum hydroxide or “alum,” a substance currently used in several commercial vaccines, will be used as part of the vaccine.

The new studies are crucial because investigators are searching for ways to stretch the supply of vaccine should a pandemic occur. If alum boosts the immune response and is shown to be safe and effective, researchers would be able to reduce the amount of vaccine given to participants but still protect them, thus making the vaccine available to more people.

Thus far the most dangerous strain of bird flu has infected at least 170 people during the last four years, mostly in Southeast Asia, and more than half the patients have died. The virus normally infects birds, and in the past few years, millions of chickens and turkeys around the globe, mainly in Southeast Asia, have died or been killed as authorities try to halt the disease’s spread. Most human victims have caught the disease from infected chickens, but a couple of isolated cases appear to have been transmitted from person to person

The risk to people will come if the virus gains a more robust ability to spread from person to person. Since most people have never been exposed to bird flu, they have no immunity to it, and doctors fear the lethal virus could then spread quickly.

John Treanor, M.D., professor of medicine and director of Rochester’s VTEU, is leading the studies in Rochester. Treanor has played a prominent role in protecting the nation from several infectious threats in recent years. Most recently he led the nationwide study that showed that the bird flu vaccine at high doses offers protection to a majority of individuals. Last year he led a nationwide study that eased the flu vaccine shortage by demonstrating that an additional flu vaccine is safe and effective. And immediately after the 9/11 tragedy he led a study showing that the supply of smallpox vaccine could be stretched if necessary and still protect people.

The two new studies are funded by the National Institute of Allergy and Infectious Disease, which supports the VTEU network so it can respond to infectious threats and protect the health of the nation’s citizens. More people in Rochester have been immunized against bird flu than in any other community in the world, thanks to the University’s role testing vaccines. During the last eight years, more than 450 people have taken part in studies of bird flu vaccines through the University’s VTEU.

Anyone interested in taking part in the new studies should call Barbara Mahoney at (585) 273-3990.

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