NIAID Expands Vaccine Testing Network
The National Institute of Allergy and Infectious Diseases (NIAID) has awarded seven new contracts that will expand and reorganize its network of university-based sites conducting clinical trials of promising vaccine candidates and therapies for infectious diseases. The reconfigured Vaccine Treatment and Evaluation Units (VTEUs) will enable NIAID to fund more clinical trials focused on specific populations as well as larger trials of public health importance, including those related to biodefense and vaccine safety.
Established in 1962, the network is a national resource for vaccine development. VTEU investigators have tested and advanced vaccines for many diseases, including pneumonia, influenza, cholera, whooping cough, malaria, and tuberculosis. Childhood vaccines and so-called combination vaccines - the delivery of several vaccines at the same time - have been and remain an important part of the network's research agenda. The first trial of an edible vaccine was conducted by VTEU researchers, and other novel vaccine delivery systems, such as an influenza vaccine delivered via a nasal spray, have been extensively tested through the network.
"For 40 years, the VTEUs have provided an important mechanism for conducting vaccine clinical trials in a variety of populations, including infants, children, adults, and specific high-risk populations," says NIAID Director Anthony S. Fauci, M.D. "More recently, part of this network's mission has been to evaluate vaccines against possible agents of bioterrorism."
An important strength of the VTEU network is its ability to rapidly recruit and retain volunteers. Through the VTEUs, NIAID quickly designed and implemented a multicenter clinical trial to evaluate the feasibility of diluting existing smallpox vaccine. Together, the VTEUs enrolled and vaccinated 680 volunteers in less than three months. Initial findings of this study were recently published in the New England Journal of Medicine. The results provide the government and vaccine advisory committees with essential information for making critical decisions about smallpox vaccination strategies.
In addition to rigorously evaluating vaccine safety during every trial, the VTEUs explore emerging hypotheses about vaccine-related adverse side effects. For example, one VTEU is studying thimerosal, a common vaccine preservative that contains a form of mercury. Thimerosal has recently been removed from vaccines routinely given to infants. To better understand what happens to thimerosal once it enters the body, the VTEU is assessing mercury levels in groups of infants who received routine immunizations either with or without thimerosal.
The new VTEU contracts will last five years; first-year funding is $23.3 million. The new VTEUs and principal investigators (PIs) are listed below:
Baylor College of Medicine
Houston, Texas
PI: Wendy Keitel, M.D | University of Maryland School of Medicine
Baltimore, Maryland
PI: Myron Levine, M.D. |
Cincinnati University Children's Hospital Medical Center
Cincinnati, Ohio
PI: David Bernstein, M.D. | University of Rochester School of Medicine and Dentistry
Rochester, New York
PI: John Treanor, M.D. |
Harbor-UCLA Research and Education Institute
Torrance, California
PI: Joel Ward, M.D. | Vanderbilt University Medical Center
Nashville, Tennessee
PI: Kathryn Edwards, M.D. |
Saint Louis University Health Sciences Center
St. Louis, Missouri
PI: Robert Belshe, M.D. | |
NIAID is a component of the National Institutes of Health (NIH), an agency of the U.S. Department of Health and Human Services. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on transplantation and immune-related illnesses, including autoimmune disorders, asthma and allergies.
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