NIH Expands Nationwide Network of Vaccine and Treatment Evaluation Units

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. 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.

“The VTEUs have been an invaluable resource for testing important vaccines and treatments against deadly emerging infectious disease threats,” said NIAID Director Anthony S. Fauci, MD. “Through these new awards, we are increasing the network’s capacity to study infectious diseases where they are endemic. This will allow us to learn more about the origin and evolution of emerging diseases and also improve the evaluation of diagnostics along with potential vaccines and treatments.”

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 influenzaeType 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 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.

“Launching and obtaining results from such studies quickly is possible because the VTEUs have proved that they can rapidly enroll large numbers of participants. This agility is especially important for testing vaccines designed to counteract emerging infectious diseases of public health concern,” said Dr Fauci.

The newly awarded VTEU sites and principal investigators (PIs) are as follows:

• Baylor College of Medicine, Houston
  PI: Wendy A. Keitel, MD

• Cincinnati Children’s Hospital Medical Center
  PI: David I. Bernstein, MD, MA

• Duke Medicine [new to VTEU program], Durham, N.C.
  PI: Emmanuel B. Walter, MD, MPH

• Emory University, Atlanta
  PI: Mark J. Mulligan, MD

• Group Health Research Institute, Seattle
  PI: Lisa A. Jackson, MD, MPH

• Saint Louis University
  PI: Robert B. Belshe, MD

• University of Iowa, Iowa City
  PI: Patricia L. Winokur, MD

• University of Maryland, Baltimore
  PI: Karen L. Kotloff, MD

• Vanderbilt University, Nashville
  PI: Kathryn M. Edwards, MD