Researchers at the University of Maryland School of Medicine’s Center for Vaccine Development (CVD) have been asked by the National Institute of Allergy and Infectious Diseases to study the safety and effectiveness of an influenza vaccine designed specifically for the elderly. Approximately 100 healthy volunteers over the age of 65 will be needed for the study, which will be conducted in Baltimore and at four other sites across the country starting April 11.
“While currently licensed flu vaccines protect up to 90 percent of the general population, they are only effective in about 30-70 percent of older individuals,” says Robert Edelman, M.D., professor of medicine and pediatrics at the University of Maryland School of Medicine and the study’s principal investigator at the Center for Vaccine Development. “Since the elderly are at an increased risk for death and serious side effects from the flu, it is especially important to protect them.”
The vaccine being tested is made by sanofi pasteur. It differs from the currently licensed flu vaccines in that it has higher concentrations of killed virus in each vaccine dose.
Half of the study participants will receive the new vaccine while half will receive the currently licensed flu vaccine, which is made by sanofi pasteur. Volunteers will complete a health screening and have their blood drawn prior to receiving a shot. They will return 28 days later to have their blood drawn again to determine their level of immunity. Sanofi pasteur will guarantee that all study volunteers will receive a flu vaccine for the fall 2005 flu season.
With a goal to increase protection for the elderly during upcoming flu seasons, the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, has asked the Center for Vaccine Development to conduct the current study because of its expertise in clinical trials involving the elderly. The center has conducted previous studies of vaccines designed for the elderly, including a Hepatitis B vaccine and a vaccine for respiratory syncytial virus.
"Vaccines are meant to equip the body with a heightened ability to fight off specific infections," says Dr. Edelman. "Since influenza is one of the most serious public health problems in the elderly, considerable effort is being made to create methods for improving the current flu vaccine for them."
Other institutions participating in the trial are Baylor College of Medicine, Cincinnati Children's Hospital Medical Center, St. Louis University Health Sciences Center and University of Iowa.
Those interested in volunteering for the study should call (410) 706-6156.
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