Strep Vaccine to be Tested in Humans (350)

MEMPHIS, Tenn. — A vaccine to prevent strep throat and rheumatic fever will be tested for the first time in humans this summer, the University of Tennessee scientist who helped develop it said Wednesday.

Dr. James Dale, an infectious disease physician at UT-Memphis and the Veterans Affairs Medical Center here, said the vaccine could help prevent the 25 million U.S. illnesses caused by a type of bacteria known as Group A streptococci.

“Our primary goal in these first human tests is to assure the safety of the vaccine,” Dale said, “but we also hope to see these individuals develop antibodies in their immune responses that should protect them against infection.

“That will be a huge step in our overall goal of preventing diseases caused by streptococci infection.”

Dale said the vaccine is designed to use a fragment of protein from the surface of strep bacteria to trigger an immune response against strep infection. It has proved safe and effective in extensive pre-clinical studies with animals, he said.

Dale is working with scientists at ID Biomedical Corp. of Seattle and the National Institutes of Health. The researchers recently received clearance from the U.S. Food and Drug Administration to begin the first clinical trials of the vaccine.

“We are pleased by the FDA’s positive response in allowing this ground-breaking clinical study of our vaccine,” said Dr. Anthony Holler, president of ID Biomedical. “This accomplishment has been made possible by the combined expertise of our subsidiary, ID Vaccine, and our collaborations with the NIH, the University of Tennessee, and VA Medical Center of Memphis.”

The first phase of human clinical trials could begin this summer with about 30 adult volunteers at the University of Maryland’s Center for Vaccine Development, Dale said. Blood tests will be conducted to determine effectiveness of the vaccine, which could be tested in children within five years, he said.

“The effects of strep-related diseases total billions of dollars annually in medical and indirect costs,” Dale said. “The impact of a vaccine that could significantly reduce the percentage of these infections would be phenomenal not only in terms of human health but also from a financial standpoint.”

Contact: Mike Bradley (423-974-2225)

Dr. James Dale (901-577-7273)