The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has awarded Emory a contract to test new vaccines and therapies for infectious, immunologic and allergic diseases in adults and children. Emory is one of nine Vaccine and Treatment Evaluation Units in the NIH VTEU network. The VTEUs are receiving Indefinite Delivery Indefinite Quantity (IDIQ) contracts with a combined estimated value of up to $135 million annually over a seven-year ordering period.
The Emory VTEU will conduct clinical research to develop and evaluate therapeutics, vaccines and diagnostics to protect people from infectious disease, including emerging threats. The VTEUs are responsible for identifying new methods to use currently available vaccines, diagnostics and treatments; clinical trials of promising investigational products; and clinical studies to better characterize responses to vaccines. VTEUs also will conduct surveillance and epidemiology studies and use systems biology approaches to prevention and treatment.
Emory was first awarded a contract and became a VTEU site in 2007. The Emory VTEU was one of the eight NIH-sponsored sites to test the H1N1 vaccine in 2009 in adults and children against a pandemic outbreak and currently is conducting a clinical trial of a vaccine designed to protect against the newly identified H7N9 avian influenza strain.
Mark J. Mulligan, MD, is principal investigator of the Emory VTEU. He is a professor of medicine in Emory University School of Medicine and executive director of the Hope Clinic of the Emory Vaccine Center. Paul Spearman, MD, is co-principal investigator. Spearman is chief research officer for Children's Healthcare of Atlanta and Nahmias-Schinazi Professor and vice chair of research in the Department of Pediatrics, Emory University School of Medicine.
"The VTEU network is a critical component of the nation's ability to prevent and treat challenging infectious diseases that threaten the health and lives of millions of people in the U.S. and throughout the world," says Mulligan. "Emory infectious disease and vaccine researchers and clinicians have been extremely successful in carrying out the mandate of the VTEU network for the past six years, and we look forward to continuing this important work through the new contract award."
Researchers will study infectious diseases caused by viral, bacterial, parasitic and fungal pathogens, drug-resistant organisms, emerging infectious diseases, and pathogens important in biodefense. The VTEU contracts will support studies spanning as wide a variety of infectious diseases as possible in a variety of domestic and international populations.
"We are often presented with vaccines that require evaluation in children as well as in adults," says Spearman. "We are ideally positioned at Emory and Children's Healthcare of Atlanta to carry out pediatric vaccine trials, and we look forward to playing a leading role in this effort for years to come."
The Georgia Research Alliance, a partnership of research universities, industry and state government, has provided a $2 million matching grant to support the Emory VTEU.
"Emory's re-selection to this premier national network is the highest recognition of our faculty's expertise in infectious diseases, vaccines, and therapeutics, and their ability to carry out critical clinical research that can potentially save millions of lives from challenging global diseases," says David S. Stephens, MD, vice president for research in Emory's Woodruff Health Sciences Center and interim chair of the Department of Medicine in Emory University School of Medicine. "We are very proud of this important new award contract."
The VTEUs were established in 1962 as a vital research component of the NIAID and a way to facilitate rapid response to emerging public health needs. Over the past five decades the VTEUs have conducted hundreds of clinical studies of bacterial, viral and parasitic vaccines, therapeutic, and other biologics and drugs as preventive and therapeutic measures against infectious diseases in people of all ages and risk categories.
The Emory Vaccine Center will play a key role in the Emory VTEU. The Vaccine Center, located at multiple sites including the Yerkes National Primate Research Center, is one of the largest and most successful academic vaccine centers in the world, with more than 27 faculty and over 200 staff focused on vaccine development and testing. The Vaccine Center's Hope Clinic has been one of the top-enrolling sites for clinical trials sponsored by the NIH.
Other VTEU sites are Baylor College of Medicine (Houston, Texas), Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio), Duke Medicine (Durham, N.C.), Group Health Research Institute (Seattle, Wash.), Saint Louis University (Saint Louis, Mo.), University of Iowa (Iowa City, Iowa), University of Maryland (Baltimore, Md.), and Vanderbilt University (Nashville, Tenn.).