Maryland Medical Center to Take Part in National Swine Flu Vaccine Study
Thursday, July 23, 2009
The University of Maryland Medical Center in Baltimore is among a group of health facilities across the country chosen to participate in human trials for swine flu vaccines.
On Wednesday, the National Institutes of Health tapped the medical centers to begin a series of studies. The first shots are to be given to healthy adults, of any age, in early August. If there are no immediate safety concerns, such as allergic reactions, testing would begin soon in children as young as 6 months, officials said.
The government and vaccine makers are seeking thousands of volunteers to roll up their sleeves for the first swine flu shots -- to test whether a vaccine will protect against this novel virus before its expected rebound in the fall.
The government will rely heavily on the study results, as well as additional research by vaccine makers, when deciding whether to offer swine flu vaccine to millions of Americans starting in mid-October. That's assuming that enough of the hard-to-make vaccine has been produced by then.
Health authorities in other countries are also looking to the U.S. studies as they make their own plans.
Unlike regular winter flu, which is generally most dangerous to people 65 and older and to those younger than 2, the swine flu that is spreading around the globe seems to disproportionately target school-age children, including teenagers, and young adults.
Officials are worried about having study results in time. "It's going to be very, very close," said Anthony Fauci, director of NIH's National Institute of Allergy and Infectious Diseases.
"We are racing to provide them as much information as we possibly can," said Karen Kotloff, a professor at the U-Md. School of Medicine who is helping to lead the NIH study. She said doctors and other health workers had been asking about enrolling in the study themselves.
All volunteers will receive two swine flu shots, 21 days apart. By early September, blood tests should show how much protection the initial dose triggered and whether a low dose worked or a higher dose was needed. It will take another month to get information on the second shot.
Besides the U-Md. medical school, main study sites are University of Iowa, Iowa City; St. Louis University, St. Louis; Baylor College of Medicine, Houston; Children's Hospital Medical Center, Cincinnati; Emory University, Atlanta; Group Health Cooperative, Seattle; and Vanderbilt University, Nashville.
Children's Mercy Hospital in Kansas City, Mo., and Duke University Medical Center in Durham, N.C., will also participate in the research.