FOR IMMEDIATE RELEASE: March 6, 2006
Contact: Becky Ceraul rceraul@som.umaryland.edu 410-706-7590
Ellen Beth Levitt eblevitt@umm.edu 410-328-8919

AVIAN FLU VACCINE STUDY AT THE UNIVERSITY OF MARYLAND WILL INVESTIGATE EFFECTIVENESS OF A LOWER DOSE

Study follows earlier trial of higher dose vaccine

Researchers at the University of Maryland School of Medicine in Baltimore will soon begin two clinical trials of a revised form of an investigational pandemic influenza vaccine against H5N1 avian influenza to see if it will stimulate immune responses in lower doses. The Center for Vaccine Development (CVD) at the University of Maryland School of Medicine will be conducting two separate trials beginning in March – one for healthy adults ages 18 to 49 and one for healthy adults ages 65 and over.

“We previously tested an inactivated pandemic influenza vaccine against H5N1 avian influenza that appears safe and leads to an immune response in adults,” says James Campbell, M.D., an assistant professor of pediatrics at the University of Maryland School of Medicine and principal investigator on the study for healthy adults. “But the current vaccine requires high doses and at least two injections to bring about moderate immune response levels. We hope that adding a compound called an adjuvant to the existing vaccine will improve its immune responses enough that only one dose will be needed at a lower concentration.”

According to Dr. Campbell, the adjuvant being added to the H5N1 influenza vaccine is aluminum hydroxide, the same compound found in other vaccines licensed in the United States, including the tetanus vaccine. “When this compound is added to an existing vaccine it may stimulate the immune system and increase the body’s response, providing more protection than a vaccine without such a compound,” he says.

The CVD at the University of Maryland School of Medicine was first asked in April 2005 by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health to test a pandemic influenza vaccine in preparation for a possible pandemic. That trial involved 450 volunteers at three sites across the country and showed that the vaccine was safe and effective.

The vaccine is aimed at protecting people from infection with H5N1 influenza, an avian flu strain that was first seen in chickens and other birds in Hong Kong in 1997. People who have direct contact with these infected animals can contract the virus and become ill.

“The H5N1 strain of avian flu currently circulating in Asia leads to severe disease in both birds and humans,” says Dr. Campbell. “Since this virus strain was first identified, there have been 169 cases of avian influenza in humans with 91 deaths. We are concerned that if this highly lethal virus becomes as contagious as the usual flu virus, it will spread quickly around the globe.”

During the new studies, the CVD will recruit up to 200 healthy adult volunteers between the ages of 18 and 49, and 100 healthy adults over the age of 65. Volunteers will have a medical screening, have their blood drawn several times and receive two vaccinations. Volunteers will be randomly assigned into two different groups – half will receive the inactivated H5N1 vaccine with aluminum hydroxide adjuvant and the other half will receive the vaccine alone. Several different doses will be tested. Compensation will be provided.

“It’s important to test this vaccine in adults over the age of 65 because we know that a disproportionate number of deaths and hospitalizations in this population are due to the regular seasonal flu virus each year,” says Robert Edelman, M.D., professor of medicine at the University of Maryland School of Medicine and principal investigator on the study for older adults. “We believe that pandemic influenza has the potential to be even more devastating in the elderly than the regular flu. It’s essential that we determine now what dose and formulation of the vaccine provides the best protection so that we can be prepared for a pandemic.”

Those interested in volunteering for either study should call the Center for Vaccine Development at (410) 706-6156.

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