NIAID strengthens and expands Vaccine and Treatment Evalua...(nation vaccinesthe delivery of several v...),Health

Date:11/6/2007

nation 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
Houston, Texas
PI: Wendy A. Keitel, M.D.

Children's Hospital Medical Center
Cincinnati, Ohio
PI: David I. Bernstein, M.D.
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Contact: Laura Sivitz sivitzl@niaid.nih.gov 301-402-1663 NIH/National Institute of Allergy and Infectious Diseases Source:Eurekalert

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