The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has awarded eight contracts to strengthen and expand its nationwide group of institutions conducting clinical trials of promising candidate vaccines and therapies for infectious diseases. In addition to increasing the number of sites from seven to eight, NIAID expects the Vaccine and Treatment Evaluation Units (VTEUs) to carry out more clinical trials in larger populations and to safely test vaccines in specific vulnerable populations, such as infants and the elderly. Moreover, all the VTEUs will have inpatient beds for isolating volunteers who participate in the testing of vaccines containing weakened versions of live microbes, making it easier to conduct such trials quickly.
Each VTEU will receive approximately $23.7 million over seven years. The combined capabilities of these research facilitieslocated in Atlanta, Baltimore, Cincinnati, Houston, Iowa City, Nashville, Seattle and St. Louiswill enhance NIAIDs ability to direct clinical research to quickly respond to emerging public health needs.
In more than four decades of research, the VTEUs have conducted hundreds of clinical trials of investigational vaccines and therapeutics for a variety of infectious diseases of public health concern, and many of these trials have contributed to the licensure of products, says NIAID Director Anthony S. Fauci, M.D. We expect this success to continue, as each VTEU has exceptional expertise and experience in vaccinology and an impressive capacity to recruit volunteers from diverse populations in its community.
Established in 1962, the VTEUs are a national resource for vaccine development. VTEU investigators have tested and advanced vaccines for many diseases, including influenza, pneumonia, whooping cough, Haemophilus influenzae infection, cytomegalovirus infection, malaria, smallpox, anthrax and tularemia. Childhood vaccines and combination vaccinesthe delivery of several vaccines through one inoculationhave been and remain an important part of the VTEUs research goals. The first trial of an edible vaccine was conducted by VTEU researchers, and other novel vaccine delivery systems have been extensively tested by this select group of medical research facilities. For example, one VTEU demonstrated that consuming genetically engineered potatoes could stimulate an immune response against Escherichia coli in humans, and six VTEUs enrolled young children in a successful Phase III trial of FluMist, an influenza vaccine delivered through a nasal spray.
An important strength of the VTEUs is their ability to enroll large numbers of volunteers into trials rapidly and vaccinate them in a manner that is safe, effective and quick to yield results. This rapid-response capability is especially important for testing vaccines designed to counteract emerging public health concerns. For example, the VTEUs conducted multiple studies in 2005 and 2006 of a vaccine for a strain of H5N1 avian influenza virus to determine the most effective dose. Those studies led to the licensure of the first vaccine approved by the U.S. Food and Drug Administration (FDA) against an H5N1 influenza virus. The units also swiftly initiated a large-scale trial to evaluate the seasonal influenza vaccine Fluarix for use in healthy adults in the United States. The trial demonstrated the vaccines safety and ability to generate an immune response and ultimately led to its expedited approval by FDA in August 2005less than a year after the trial began. This approval helped reduce the impact of future delays or shortages of seasonal influenza vaccines in the United States.
The selected VTEU sites and principal investigators (PIs) are as follows.
Baylor College of Medicine
PI: Wendy A. Keitel, M.D.
Children's Hospital Medical Center
PI: David I. Bernstein, M.D., M.A.
PI: Mark J. Mulligan, M.D.
Group Health Cooperative
PI: Lisa A. Jackson, M.D., M.P.H.
Saint Louis University
St. Louis, Missouri
PI: Robert B. Belshe, M.D.
University of Iowa
Iowa City, Iowa
PI: Patricia L. Winokur, M.D.
University of Maryland
PI: Karen L. Kotloff, M.D.
PI: Kathryn M. Edwards, M.D.
|Contact: Laura Sivitz|
NIH/National Institute of Allergy and Infectious Diseases