UT Researcher Makes Headway with Experimental Strep Vaccine

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UT professor, James B. Dale, MD, is involved in a clinical research study that is making headway in developing a vaccine against a common strep germ. Results of the study co-authored by Dr. Dale are reported in the August 11 issue of JAMA.

For an interview with Dr. James B. Dale

Recent research advances have allowed past obstacles to be overcome that were associated with the development of group A streptococcal vaccine. The following are results of the Streptococcal Vaccine Clinical Trial that appear in August 2004 issue of the Journal of American Medical Association (JAMA):

Dr. James Dale is a co-author of a paper that will appear in the Journal of the American Medical Association describing a phase 1 clinical trial of a group A streptococcal vaccine that was invented in Memphis, Tennessee at the Veterans Affairs Medical Center and the University of Tennessee. “The results of this study are significant because this is the first streptococcal vaccine to be tested in humans in more than 25 years,” said Dr. Dale. The vaccine, which was developed as a prototype, is designed to prevent infection by 6 of the more important types of group A streptococci. In this study, 28 adult volunteers received the vaccine, which was well tolerated and stimulated a significant immune response predicted to protect against infection. The primary end-point of this study was to determine the safety profile of the vaccine in a number of adult volunteers.

Group A streptococcal infections cause a spectrum of clinical illnesses, ranging from uncomplicated “strep throat” to “flesh eating disease” and toxic shock syndrome. Streptococcal sore throat may also lead to acute rheumatic fever and rheumatic heart disease in a small percentage of individuals. It is estimated that 10-15 million cases of strep throat occur in the U.S. each year. The CDC estimates that up to 10,000 cases of serious,

life-threatening infections occur per year in the U.S. Rheumatic fever and rheumatic heart disease, although relatively uncommon in the U.S. and other developed countries, is very common in the underdeveloped countries of the world. The World Health Organization estimates that 400,000 people die each year from rheumatic heart disease and as many as 12 million may suffer from the disease.

“An effective vaccine could have a significant impact on the health of millions of children around the world,” said Dr. Dale. The prototype vaccine reported this week in JAMA has paved the way for the testing of a more complex vaccine that has been manufactured based on the same technology and is designed to protect against 26 different types of strep that account for as much as 80-90% of the infections in the U.S. and Canada. The 26-valent vaccine is now being tested in adult volunteers by ID Biomedical Corporation and tests in children are planned for next year.

BRIEF

James B. Dale, M.D., Associate Chief of Staff for Education (ACOS), VA Medical Center, Memphis, Tennessee, and Chief, Infectious Diseases, University of Tennessee Health Science Center, is the inventor of the vaccine technology for group A streptococcus, the bacteria that causes strep throat infection, rheumatic fever, which is the leading cause of heart disease among children, and skin infections. He is a leader in academic medicine whose work has been published in numerous medical and research journals. He has received several awards and honors for accomplishments during his career and has been recognized nationally and internationally for his research.