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University of Maryland School of Medicine Receives $23.7M to Continue Testing Vaccines for the Federal Government

Tuesday, November 20, 2007

 Karen Kotloff, M.D. is the principal investigator on the VTEU grant.

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has renewed a contract with the University of Maryland School of Medicine to conduct clinical trials of promising vaccines and therapies for infectious diseases. The School of Medicine’s Center for Vaccine Development (CVD) will receive $23.7 million over seven years as a Vaccine and Treatment Evaluation Unit (VTEU) for NIAID. The CVD VTEU and seven other VTEUs will enhance NIAID’s ability to quickly respond to emerging public health needs.
"As a VTEU, the Center for Vaccine Development has been testing vaccines for the federal government for more than three decades, focusing on preventing a wide array of  infectious diseases that affect children, adults and the elderly," says Karen Kotloff, M.D., a professor of pediatrics and medicine at the University of Maryland School of Medicine and principal investigator on the VTEU grant. "Investigators at the CVD have a tremendous appreciation for the potential impact of vaccines as a public health tool. This renewal from the NIAID provides us with a wonderful opportunity to continue our commitment to bringing new and improved vaccines to populations who can benefit from them the most."

Established in 1962, the VTEUs are a national resource for vaccine development. "The program has been instrumental in facilitating the clinical development of vaccines that are important for public health," says Dr. Kotloff. "These include vaccines for diseases such as pandemic and seasonal influenza, whooping cough, Norwalk virus, and sexually transmitted diseases such as herpes – which are common in the United States – as well as malaria, dysentery, cholera and typhoid fever – illnesses that primarily affect people in developing countries.

"New and improved vaccines to protect the public against a bioterrorism threat with smallpox, anthrax and other diseases have also been tested," Dr. Kotloff continues. "The program has also advanced the development of vaccines that pose particular scientific challenges, such as those for group-A streptococcal infections."

In addition,"we have conducted several hundred studies at our VTEU over the years, and many innovative approaches for vaccine delivery have been tried, including edible vaccines, needle-free injection and skin patches," Dr. Kotloff says.

Most recently, the CVD VTEU participated in 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 (FDA) 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.

The CVD VTEU also conducted multiple studies in 2005 and 2006 on a vaccine for a potential pandemic strain of influenza to determine the most effective dose. Those studies led to the licensure of the first FDA-approved vaccine against a strain of H5NI avian influenza virus. In the future, the CVD VTEU and the seven other VTEUs will conduct studies to determine the best timing of vaccinations in different populations against the H5N1 influenza virus.

The NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on basic immunology, transplantation and immune-related disorders, including autoimmune diseases, asthma and allergies.

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