Researchers at the University of Maryland School of Medicine in Baltimore will begin a clinical trial on April 4 to test the effectiveness of a new vaccine against avian influenza. The University of Maryland Center for Vaccine Development is one of three sites in the country chosen by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, to test the vaccine in healthy adults.
The vaccine is aimed at protecting people from 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. Recently, there have been probable cases of the disease being transmitted from one person to another -- a worrisome discovery that means this type of flu could spread rapidly within a large population.
“The strain of avian flu currently circulating in Asia leads to severe disease in both birds and humans,” says James Campbell, M.D., an assistant professor of pediatrics at the University of Maryland School of Medicine and principal investigator for the study.
“Although fewer than 100 people in Vietnam and Thailand are reported to have had this type of flu, three-quarters of them died. Recently, the virus may have spread from person to person. If this highly lethal virus becomes as contagious as the usual flu virus, it will quickly spread around the globe,” says Dr. Campbell.
He adds that avian flu has the potential to cause a worldwide pandemic because humans have no immunity to the virus and currently there is no vaccine for it. “It’s critical that an effective vaccine be developed to provide protection in the event of an outbreak,” Dr. Campbell says.
Under the direction of the National Institute of Allergy and Infectious Diseases, the University of Maryland Center for Vaccine Development will recruit approximately 150 healthy adult volunteers between the ages of 18 and 64 to participate in the seven-month study. During the study, volunteers will have a medical screening, have their blood drawn at several intervals and receive two vaccinations. About 11 percent of the volunteers will receive a placebo. Compensation will be provided.
“This vaccine, made by sanofi pasteur, previously Aventis Pasteur, is produced in the same fashion as the currently licensed influenza vaccine, only it uses the avian virus strain and not the ‘regular’ flu strains,” says Dr. Campbell. “We believe this vaccine is safe because it is made by a reputable manufacturer of other vaccines used in the United States, and previous smaller scale human studies of other avian influenza vaccines didn’t report any unexpected safety concerns associated with the vaccine.”
“If we can show that this vaccine is safe and stimulates an immune response, larger studies will be conducted and will include children and the elderly,” adds Dr. Campbell. “Eventually, we hope that a vaccine will be licensed for use to provide people with the protection needed to reduce the public health impact from exposure to avian flu.”
Other institutions participating in this study of healthy adults are the University of Rochester and the University of California-Los Angeles.
Those interested in volunteering for the study should call the Center for Vaccine Development at (410) 706-6156.