A national effort to improve defenses against bioterrorism has resulted in the biggest government grant ever received by Cincinnati Children's Hospital Medical Center.

        The hospital will use a five-year, $21.7 million grant from a unit of the National Institutes of Health to expand its study of vaccines, especially for smallpox and other viruses that might be used as weapons.

VACCINE UNIT

Name: Vaccine and Treatment Evaluation Unit     Founded: 1994     The news: The unit has received a five-year, $21.7 million grant from the National Institutes of Health, the largest in the history of Cincinnati Children's Hospital Medical Center.     Background: The unit started as one of five, now seven, national testing centers for new vaccines, designated by the NIH.     The center is studying several promising vaccines for rotavirus, cytomegalovirus, hepatitis B, adult influenza, childhood influenza, adult pertussis and two forms of herpes simplex virus. The new grant adds funds to study smallpox and other viruses that could be used as weapons.     In addition to searching for new vaccines, the unit studies novel ways to deliver vaccines, such as skin patches, nasal sprays and oral liquids as alternatives to injections.

        “In our budget, we originally asked for about the same amount we already were receiving. But they said we want you to double your personnel, because we're going to have a lot of work to do to study the new vaccines that come along,” said Dr. David I. Bernstein, director of the hospital's division of infectious diseases.

        The pediatric hospital has been studying vaccines for many years. It was here that Dr. Albert Sabin invented the oral polio vaccine that has been credited with nearly eliminating the disease worldwide.

        In 1994, the hospital became one of five NIH-designated Vaccine and Treatment Evaluation Units, which have since been increased to seven. The first grant to the unit was for $12 million over seven years.

        Children's Hospital plays a frequent role in testing a wide range of vaccines and vaccine-delivery concepts. That role will expand as researchers nationwide work on ways to protect against smallpox and other potential threats.

        “For 40 years, the (vaccine centers) have provided an important mechanism for conducting vaccine clinical trials in a variety of populations, including infants, children, adults and specific high-risk populations,” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID).

        “More recently, part of this network's mission has been to evaluate vaccines against possible agents of bioterrorism.”

        After the Sept. 11 terrorist attacks, the network quickly launched a multicenter clinical trial of 660 adult patients to evaluate the feasibility of diluting existing smallpox vaccine. Soon, Cincinnati Children's and counterparts at UCLA will conduct a similar study for children.

        “This contract places Cincinnati in the forefront of a national effort to combat infectious diseases,” Dr. Bernstein said. “And this is an exciting time for vaccine research, because we're learning all sorts of ways to make new vaccines.

        “Vaccines are the most cost-effective way there is to combat infectious disease,” he said. “With vaccines, it can cost just pennies to save a life.”

        The other medical centers in the network are Baylor College of Medicine, Houston; Harbor-UCLA Research and Education Institute, Torrance, Calif.; Saint Louis University Health Sciences Center in St. Louis; University of Maryland School of Medicine in Baltimore; University of Rochester School of Medicine and Dentistry in Rochester, N.Y.; and Vanderbilt University Medical Center in Nashville, Tenn.

        At Cincinnati Children's, vaccine study areas have included:

        • Cytomegalovirus (CMV), the second most common cause of mental retardation and deafness in children, affecting 40,000 infants a year. It also may aggravate the effects of heart disease.

        In 1994, Children's Hospital researchers isolated a gene that helps form the virus' outer protein shell, a possible target for a vaccine. Animal tests in 1996 showed that a prototype vaccine protects guinea pigs. Some human testing has begun, Dr. Bernstein said.

        • Rotavirus, the most important known cause of severe diarrhea among children under age 2, killing more than 600,000 children a year worldwide. In the past decade, Children's Hospital researchers have patented two vaccines.

        One of the vaccines, Rota-Shield, developed in conjunction with Wyeth-Ayerst Laboratories, was pulled from the market in 1998 after about 100 children suffered intestinal blockages. After publishing promising results from clinical trials in 1999, the other vaccine was sub-licensed to SmithKline Beecham, now GlaxoSmithKline, for continued testing.

        • Influenza, which kills about 20,000 people a year, mostly among the elderly and chronically ill. Researchers have long been concerned that older people catch the virus from unvaccinated children.

        Children's was involved in early studies of FluMist, a nasal flu vaccine spray for children, made by Aviron Corp. of Mountain View, Calif. In 2001, a Food and Drug Administration advisory committee ruled that the vaccine needed more study on possible interactions with other vaccines before it could be approved. That information has been compiled and awaits an FDA decision, Dr. Bernstein said.
       
       

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