Edwards To Lead H1N1 Vaccine Trial

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Kathryn Edwards, M.D., professor of Pediatrics, Director of the Vanderbilt Vaccine Research Program, and Principal Investigator for the Vanderbilt VTEU will lead a Vanderbilt pediatric and adult vaccination test-site for a new H1N1 influenza vaccine.

Vanderbilt's VTEU is one of a nationwide network of vaccine units funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The VTEUs are conducting these trials that will recruit volunteers and test the vaccine beginning this month. Vanderbilt's VTEU is one of just eight in the country, and is one of only two located in the Southeast.

The clinical trials will enroll as many as 1,000 healthy adults and children at 10 centers nationwide. Vanderbilt will begin pediatric trials on children 6 months to 17 years old on Aug. 19. The trial will enroll 40 children in each of three age groups: 6-36 months; 36 months to 9 years; and 10-17 years. The vaccine is inactivated and cannot transmit the flu virus.

"We are very excited to be a part of such important work. Through the vaccine trials conducted at Vanderbilt, Nashville and Middle Tennessee have played an important role in the development of many vaccines in use today," Edwards said. "Once again we need the help of Middle Tennesseans to rise to this challenge so we can help the rest of the country."

According to the Centers for Disease Control and Prevention (CDC), as of July 17, there have been more than 40,000 documented cases of H1N1 influenza in the United States occurring in all 50 states and four U.S. territories, resulting in 263 deaths so far.

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"The H1N1 flu outbreak continues its march here in Tennessee and around the globe, achieving global pandemic status by World Health Organization standards," said Edwards. "The H1N1 outbreak has been declared a public health threat by our government."

In Tennessee there have been 247 confirmed cases of H1N1 resulting in one death so far. This death occurred at VUMC in early July.

"There is a real urgency to test and approve a safe, effective vaccine by fall. At Vanderbilt we will conduct a series of trials of the H1N1 flu vaccine. The first trial will involve adult participants. Later trials will include children," Edwards said.

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 trials 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 in these 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," said Karen L. Kotloff, M.D., professor of Pediatrics at the University of Maryland's School of Medicine and lead investigator on this study. "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. 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."

Vanderbilt's VTEU researchers also will participate in future studies of the vaccine within the NIAID's nationwide network of VTEUs. 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 the H1N1 vaccine trials include the University of Maryland School of Medicine, 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. They will be joined in these trials by Children's Mercy Hospital in Kansas City and Duke University Medical Center.

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