MEMPHIS–A strep throat vaccine developed at the University of Tennessee medical school might be the first tested on humans, a UT-Memphis professor who helped create it said Tuesday.
Dr. James Dale said the vaccine protects laboratory animals from streptococci bacteria without causing dangerous side effects in the animals’ immune systems, as other experimental vaccines have done.
It is the first treatment safe enough to be considered for clinical trials, Dale said.
He is working with ID Vaccine Corp. of Vancouver, British Columbia, and the National Institutes of Health for FDA approval in 1998 to test humans, perhaps as early as next summer. Initially, about 30 people would be vaccinated, he said.
Dale said other experimental streptococci vaccines have caused rheumatic fever in animals, stimulating the animal’s immune system to attack and damage the heart, liver and other tissue.
“The safety of these vaccines depends on eliminating these harmful effects,” Dale said. “In our tests, immunized rabbits do not make these potentially dangerous antibodies. We have genetically engineered the vaccine to contain only beneficial, not harmful, effects.
“This safety issue is important in relation to the Food and Drug Administration granting approval for human trials.”
In North America, the U.S. Centers for Disease Control and Prevention estimates up to 40 million cases of strep throat occur each year,totaling $2 billion in medical costs.
Many streptococci are harmless, but the types investigated at UT cause strep throat, rheumatic fever, toxic shock syndrome and other diseases.
The infection is treated with penicillin or other antibiotics, but there is no safe, effective vaccine to prevent streptococcus diseases.
Dale said researchers at UT-Memphis have been working on the vaccine for 33 years.
“I am the third generation in this lab to continue the work,” Dale said. “I am real excited that we are going to finally take it to the clinical trials and bring that work to fruition.”
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Contact: Dr. James Dale (901-577-7207)