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Vanderbilt’s Vaccine and Treatment Evaluation Unit (VTEU) is one of nine U.S. sites funded by the National Institute of Allergy and Infectious Disease (NIAID), part of the National Institutes of Health (NIH), to test the effectiveness of a vaccine to protect against the H7N9 bird flu that emerged in China this spring.
There have been 135 cases of illness and 44 deaths in what is so far characterized as an isolated outbreak of H7N9 influenza in Eastern China. The high mortality rate of the new strain caused the Centers for Disease Control and Prevention (CDC) to issue provider alerts to watch for flu-like illness in recent travelers to China. It has also led vaccine scientists to find ways to protect the public should there be an outbreak of H7N9 bird flu in humans.
Kathryn Edwards, M.D., Sarah H. Sell and Cornelius Vanderbilt Professor of Pediatrics, director of the Vanderbilt Vaccine Research Program, and principal investigator of Vanderbilt’s VTEU, said that testing vaccines aimed at this new H7N9 influenza will be critical in protecting against the illness in adults.
“H7N9 has spread from birds to people, and in at least one confirmed case from one person to another. Once efficient person-to-person transmission occurs, widespread infection is just around the corner. Currently this influenza strain has a 30 percent mortality rate, so the stakes are very high,” Edwards said.
Two concurrent Phase II clinical trials are designed to gather safety and dosing information for the candidate vaccine. The trial being conducted at the Vanderbilt VTEU will enroll up to 1,000 adults nationally who are 19-64 years old and in good health. It will also study the vaccine with or without adjuvants, which are substances designed to boost the body’s immune response to vaccination.
The sites will collectively enroll up to 1,000 study participants for the first round of H7N9 vaccine testing.
“In general, the immune response to bird flu vaccines is much less than to seasonal flu vaccines; therefore these studies will be very important for us to understand how to protect people in the event that it spreads across the globe,” said Buddy Creech, M.D., MPH, assistant professor of Pediatric Infectious Diseases, assistant director of the VVRP and co-principal investigator of the Vanderbilt VTEU.
In addition to the Vanderbilt VTEU, other sites include St. Louis University; Baylor College of Medicine, Houston; Children’s Hospital Medical Center, Cincinnati; Emory University, Atlanta; Group Health Cooperative, Seattle; University of Iowa, Iowa City; and University of Maryland, Baltimore. Additionally, The University of Texas Medical Branch at Galveston will be conducting the trial as a subcontractor to Baylor College of Medicine.
Further information about both clinical trials can be found at ClinicalTrials.gov using the identifiers: NCT01938742 and NCT01942265.
To learn more about the vaccine research being conducted at Vanderbilt call (615) 322-2730 or email vaccineresearch@vanderbilt.edu.
