July 24, 2009

VMC to conduct early trials of H1N1 flu vaccine

VMC to conduct early trials of H1N1 flu vaccine

The Vanderbilt Vaccine and Treatment Evaluation Unit (VTEU) will participate in the nation's first studies of an experimental vaccine designed to prevent infections from the 2009 H1N1 influenza virus.

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 in August. Vanderbilt's VTEU is one of just eight in the country, and is one of only two in the Southeast.

The clinical trials will enroll as many as 1,000 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 government's stated goal of developing a safe and effective vaccine against H1N1 and making it available to the public before the flu season begins in the fall.

Kathryn Edwards, M.D., professor of Pediatrics, director of the Vanderbilt Vaccine Research Program and principal investigator for the Vanderbilt VTEU, will lead the Vanderbilt portion of the trials.

“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.

“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.

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.

For more information on H1N1 vaccine studies at VUMC visit www.vvrp.info or call 322-2730. For more information about all clinical trials visit www.clinicaltrials.gov.