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Cincinnati Children's Awarded $23.7 Million NIH Contract As One of Eight National Vaccine Treatment and Evaluation Units

Monday, January 01, 0001

CINCINNATI -- Cincinnati Children's Hospital Medical Center has received a seven-year, $23.7 million contract from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), as one of eight Vaccine and Treatment Evaluation Units (VTEUs) in the United States.

"This contract places Cincinnati in the forefront of a national effort to combat infectious diseases and offers us the opportunity to be the leader in developing and testing vaccines," says David Bernstein, M.D., principal investigator and director of Infectious Diseases at Cincinnati Children's. "Vaccines are the single most cost-effective strategy we have to combat infectious diseases."

The contract is among the largest contracts or grants that Cincinnati Children's has ever received. The award renews and increases both the 1994 contract under which Cincinnati Children's was named a VTEU and the 2002 renewal earned by the division of Infectious Diseases and Gamble Program for Clinical Studies.

The NIAID awarded the new contracts to expand and strengthen its group of institutions nationwide conducting clinical trials of promising candidate vaccines and therapies for infectious diseases. The NIAID expects the VTEUs to carry out more clinical trials in large populations and to safely test vaccines in specific vulnerable populations, such as infants and the elderly.

Among current targeted efforts are vaccines for congenital cytomegolovirus (CMV), the leading cause of infection of unborn infants, and for avian influenza. Cincinnati Children's is leading the CMV studies and is among the leaders of select avian influenza studies.

Established in 1962, the VTEUs are a national resource for vaccine development. VTEU investigators have tested and advanced vaccines for many diseases, including pandemic influenza, pneumonia, whooping cough, Haemophilus influenzae infection, malaria, smallpox, anthrax and tularemia. 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 VTEUs' research goals. The first trial of an edible vaccine was conducted by VTEU researchers, and other novel vaccine delivery systems, such as an influenza vaccine delivered through a nasal spray, have been extensively tested by this select group of medical research facilities.

An important strength of the VTEUs is their ability to rapidly recruit and retain volunteers. For example, the units swiftly initiated a large-scale trial to evaluate the seasonal influenza vaccine Fluarix for use in healthy adults in the United States. The trial yielded the clinical information needed to win approval from the U.S. Food and Drug Administration in August 2005—less 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.

Approximately 50 clinical studies have been conducted during the past three years at VTEU contract award sites. Several of these studies were performed in a compressed time frame to address emergent public health research needs.

Other selected VTEU sites are Baylor College of Medicine, Emory University, St. Louis University, University of Maryland, Group Health Cooperative in Seattle, University of Iowa and Vanderbilt University.

Cincinnati Children's Hospital Medical Center, one of the leading pediatric research institutions in the nation, is dedicated to changing the outcome for children throughout the world. Cincinnati Children's ranks second among all pediatric institutions in the United States in grants from the National Institutes of Health. It has an established tradition of research excellence, with discoveries including the Sabin oral polio vaccine, the surfactant preparation that saves the lives of thousands of premature infants each year, and a rotavirus vaccine that saves the lives of hundreds of thousands of infants around the world each year. Current strategic directions include the translation of basic laboratory research into the development of novel therapeutics for the treatment of disease, and furthering the development of personalized and predictive medicine.