Goal is to increase supply of approved flu vaccine in the U.S.
Federal health officials have asked the Center for Vaccine Development at the University of Maryland School of Medicine in Baltimore to test an influenza vaccine that is not currently licensed in the United States, but is widely used in more than 70 other countries, including the United Kingdom and Australia.
If the vaccine, made by GlaxoSmithKline Biologicals based in Rixensart, Belgium, is found to be safe and effective, it could possibly become available in the U.S. during next winter's flu season. The fast-track clinical trial is being conducted at the University of Maryland School of Medicine and at three other testing sites.
"We are seeking 150 to 250 healthy volunteers, ranging in age from 18 to 64, to test this vaccine's safety and effectiveness against the currently circulating strains of influenza," says James Campbell, M.D., assistant professor of pediatrics at the University of Maryland School of Medicine and principal investigator of the study.
"Given that the United States is faced with a severe shortage of influenza vaccine this season, it is imperative that we test additional vaccines to add to our nation's supply. This one is similar to flu vaccines currently licensed in the United States, and it has been given to more than 126 million people around the world. The information we obtain during this trial will help the Food and Drug Administration determine whether the vaccine should be licensed here," says Dr. Campbell.
The University of Maryland researchers will vaccinate volunteers between December 13 and 22. Before receiving their shot, volunteers will have their blood drawn in order to assess their level of immunity. The participants will have their blood drawn again three weeks after the shot to see if they have developed an immune response.
The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, selected the University of Maryland Center for Vaccine Development to conduct the fast track study because of its researchers' extensive experience in vaccine research and testing. The other sites participating in the study are the University of Rochester, Cincinnati Children's Hospital, and Baylor College of Medicine.
According to the Centers for Disease Control and Prevention, millions of Americans become ill with influenza each year, and about 36,000 people die because of complications from the flu. Those at highest risk of complications include people over age 65, children ranging in age from 6 to 23 months, and those with chronic illnesses, including heart and lung diseases, as well as conditions that cause a weakened immune system, such as HIV/AIDS.
Vaccinations are also recommended for health care workers, residents of nursing homes and other chronic care facilities. In addition to possible protection against the flu, study participants may enable more people to receive a flu vaccination next season, which potentially could help save the lives of those at highest risk of life-threatening complications from influenza.
Those interested in participating in the influenza vaccine clinical trial should call 410-706-6156.
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