School of Medicine Leads Early Trials of H1N1 Flu Vaccine

For immediate release: July 22, 2009

Contact:

Karen Robinson

karobinson@som.umaryland.edu | 410-706-7590

National Study Will Involve Up to 1,000 Volunteers

[For more information about participating in clinical trials for the H1N1 flu vaccine, please call the Center for Vaccine Development at 410-706-6156, or visit www.clinicaltrials.gov.]

The University of Maryland School of Medicine's Center for Vaccine Development will lead one of the nation's first studies of an experimental vaccine designed to prevent the 2009 H1N1 influenza virus. The Center for Vaccine Development is one of a nationwide network of Vaccine and Treatment Evaluation Units (VTEUs) funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The VTEUs are conducting the trial, which will recruit volunteers and test the vaccine beginning in August.

The clinical trial will enroll as many as 1,000 healthy adults and children at 10 centers nationwide to evaluate the safety of the vaccine and measure its ability to stimulate immune responses to the H1N1 virus. The research is a first step toward the U.S. government's stated goal of developing a safe and effective vaccine against the H1N1 strain of influenza and making it available to the public before the flu season begins in the fall.

“The H1N1 flu outbreak has been declared a global pandemic by the World Health Organization and a public health emergency by the U.S. government,” says Karen L. Kotloff, M.D., professor of pediatrics, a lead investigator at the VTEU and a researcher in the Center for Vaccine Development at the University of Maryland School of Medicine. “This virus has the potential to cause significant illness with hospitalizations and deaths during the U.S. flu season this fall and winter. Vaccines have always been a vital tool for controlling influenza. The results of these studies will help to guide the optimal use of the H1N1 vaccines in the U.S. and elsewhere in the world.”

“Our Center for Vaccine Development has been home to one of the NIAID's Vaccine and Treatment Evaluation Units for more than three decades,” says E. Albert Reece, M.D., Ph.D., M.B.A., dean of the University of Maryland School of Medicine.

“Our VTEU is now one of just eight in the country, and it is the only one in the mid-Atlantic region,” says Dean Reece, who also serves as Vice President for Medical Affairs, University of Maryland, and the John Z. and Akiko K. Bowers Distinguished Professor at the School of Medicine. “We're very pleased the NIAID has chosen our top-tier researchers as leaders in the effort to stop the H1N1 pandemic before the 2009 influenza season begins.”

All participants in the trial will receive two doses of vaccine three weeks apart. The response after one dose versus two doses will be compared. The trial also will evaluate two strengths of the vaccine to determine which strength is required to stimulate an immune response that is most likely to protect people against the H1N1 flu. The vaccine will be tested in five different age groups. First, researchers will test the vaccine in healthy adult and elderly volunteers. If the vaccines are well tolerated those groups, then the researchers will begin testing the vaccine in children. Ultimately, as many as 200 adults, 200 seniors and 600 children may be enrolled in the trials.

“The response to the vaccine may vary in different age groups,” Dr. Kotloff said. “This is because young people have not seen a flu virus like this one before. Older adults might have some immunity to the new H1N1 virus as a result of being exposed to similar flu viruses in the past. As a result, older adults might need fewer doses or a lower strength of the vaccine than younger individuals.”

In addition to involving Dr. Kotloff, the lead investigator, trials at the University of Maryland School of Medicine VTEU also will involve co-investigators Wilbur H. Chen, M.D., assistant professor of medicine, and Ina Stephens, M.D., assistant professor of pediatrics. Individuals will be able to volunteer for the trial at sites in Baltimore, Frederick and Annapolis. In Baltimore, the testing will take place at the University of Maryland Medical Center.

University of Maryland School of Medicine researchers also will participate in future studies of the vaccine that will be led by other members of the NIAID's nationwide network of Vaccine and Treatment Evaluation Units. Those trials will examine important questions such as how the vaccine works in combination with the seasonal flu vaccine and whether including an adjuvant, which boosts the immune response to vaccines, can make the vaccine work better at lower doses.

The eight VTEU sites participating in these H1N1 vaccine trials include the University of Maryland School of Medicine as well as Baylor College of Medicine, Cincinnati Children's Hospital Medical Center, Emory University, Saint Louis University, Seattle Group Health Cooperative, the University of Iowa, and Vanderbilt University. They will be joined by Children's Mercy Hospital in Kansas City and Duke University Medical Center.

“Learning the responses of different age groups of people to the vaccine will not only tell us the best way to use the vaccine in an individual, but we also learn ways to use the vaccine supply most efficiently to protect the greatest number of people,” says Dr. Kotloff.

“The Center for Vaccine Development is an internationally known facility devoted to the use of vaccination to control of infectious diseases such as typhoid, measles, Hib meningitis, cholera, Shigella dysentery and malaria,” says Myron M. Levine, M.D., D.T.P.H., a professor of medicine, head of the Division of Geographic Medicine and director of the Center for Vaccine Development at the School of Medicine. “We're delighted to play such a key role in the quest for an effective vaccine for this new, emerging strain of influenza.”

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