A nationwide group of institutions that conducts clinical trials of promising candidate vaccines and therapies for infectious diseases, known as the Vaccine and Treatment Evaluation Units (VTEUs), has been awarded nine contracts to strengthen and broaden the scope of its research. Group Health Research Institute is one of these institutions. With these new awards, the National Institute of Allergy and Infectious Diseases (NIAID) will increase the number of funded institutions from eight to nine and expand the ability of the VTEUs to conduct research in domestic and international research locations, including resource-poor settings.
Each institution has the potential to receive funding from the NIAID, part of the National Institutes of Health, estimated to be up to $135 million annually over a seven-year period. (During the past seven years, Group Health Research Institute's VTEU funding averaged $3 million a year.)
"Group Health is the only one of the nine VTEU centers located west of the Rockies-and the only one not at a university medical center," said Lisa A. Jackson, MD, MPH, principal investigator of the Group Health VTEU and a senior investigator at Group Health Research Institute. "With this new contract, we will be continuing the work we started when we joined the VTEU network in 2007." The Group Health VTEU is currently focusing on evaluating the new H7N9 influenza strain that caused an outbreak when it was transmitted from birds to people in China last spring. "We will be evaluating a wide range of vaccines in addition to flu vaccines, including smallpox, pneumococcal, and other vaccines, in populations including children, adults, and the elderly," she added.
Established in 1962, the VTEUs have conducted hundreds of clinical trials, many of which have contributed to vaccine licensure. VTEU investigators have tested vaccines and therapeutics for diseases such as influenza, pneumonia, pertussis, Haemophilus influenzae type B infection, cholera, anthrax, malaria, and tuberculosis. Childhood vaccines and combination vaccines-the delivery of several vaccines through one inoculation-have been and remain an important part of the VTEUs' research goals.
For example, the network is evaluating the safety of and immune response generated by the pertussis vaccine Tdap in pregnant women and the effect of immunizing expectant mothers on their infants' immune responses to DTaP, the pertussis vaccine that is routinely administered to children.
In 2001, responding to biodefense concerns, the VTEUs conducted a trial that showed that stockpiled smallpox vaccine could be diluted up to five times and retain its potency, which meant that the original 15.4 million doses were actually enough to protect 77 million people from smallpox infection. More recently, when a new strain of H1N1 influenza emerged in 2009, the VTEUs initiated a series of clinical trials to assess the safety of and immune system response to various dosing regimens of candidate vaccines in healthy adults, elderly people and healthy children. The results of these trials were made available within a few months and helped public health officials and policy makers determine the most appropriate dose of vaccine. Earlier this month, the VTEUs launched two clinical trials to evaluate an investigational vaccine against the H7N9 avian influenza virus that emerged in humans in China earlier this year.
These are the newly awarded VTEU sites and principal investigators (PIs):
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Baylor College of Medicine, Houston, Texas; PI: Wendy A. Keitel, MD
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Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio; PI: David I. Bernstein, MD, MA
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Duke Medicine [new to VTEU program], Durham, North Carolina; PI: Emmanuel B. Walter, MD, MPH
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Emory University, Atlanta, Georgia; PI: Mark J. Mulligan, MD
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Group Health Research Institute, Seattle, Washington; PI: Lisa A. Jackson, MD, MPH
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Saint Louis University, St. Louis, Missouri; PI: Robert B. Belshe, MD
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University of Iowa, Iowa City, Iowa; PI: Patricia L. Winokur, MD
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University of Maryland, Baltimore, Maryland; PI: Karen L. Kotloff, MD
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Vanderbilt University, Nashville, Tennessee; PI: Kathryn M. Edwards, MD
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