For Release: Wednesday, Oct 22 1997

Contact: Jess Gomez

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SALT LAKE CITY -25 percent or more of cases of insulin dependent diabetes mellitus that occur before age 15 may possibly be prevented by immunizing children with common pediatric vaccines at birth, rather than waiting until up to eight weeks of life, according to a new epidemiological study by researchers at LDS Hospital in Salt Lake City and Classen Immunotherapies in Baltimore, Maryland.


Results of the analysis, which are published in today's issue of the journal, Infectious Diseases in Clinical Practices, suggest that the timing of common pediatric immunizations may alter the development of insulin-dependent diabetes in humans. Investigators say vaccines given at birth may possibly prevent children from being colonized with diabetes-inducing viruses from their mother.


The lead author of the paper is David C. Classen, MD, a researcher in the division of infectious disease at LDS Hospital and faculty member of the University of Utah School of Medicine. Co-author is J. Barthelow Classen, MD, MBA, from Classen Immunotherapies.


Utilizing epidemiological and statistical models developed at LDS Hospital, the researchers compiled and compared data from European countries that show immunization at birth with the BCG vaccine, a common vaccine used to prevent tuberculosis, may be associated with the equivalent of a 33 percent reduction. of insulin-dependent diabetes in most European countries by age 15.


By contrast, the analysis showed immunization with the BCG vaccine starting at school-age may be associated with a, substantial increased risk of insulin dependent diabetes. Data included in the paper also link rises in the incidence of the disease, also know as Type I diabetes, to the administration of the hepatitis B and hemophilus B vaccine in children who were vaccinated after they were two months old.


The incidence of the Type I diabetes was correlated with immunization schedules in all Western European nations (except Germany) from 1986-1990 because of the extensive diabetes registries maintained by each country. Also, immunization schedules in those nations varied giving investigators an opportunity to compare data.


The epidemiological data supports findings from previous animal studies conducted by Classen Immununotherapies (Autoimmunity, 1996, 24.137-145), that found that immunization of rodents at birth with common pediatric vaccines was associated with a decreased risk of Type I diabetes while administration of the whole cell pertussis vaccine at eight weeks of life was associated with an increased risk of the disease.


How might this occur? Dr. David Classen suggests that immunization with a wide variety of vaccines may alter the risk of type 1 diabetes by the release of interferon and other immune mediators in a newborn's system.


"Interferon released at birth following immunization may prevent children from being colonized with diabetes-inducing viruses from their mother,- says LDS Hospital's Dr. Classen a board-certified specialist in internal medicine and infectious disease. "By contrast after children are eight weeks or older they may have sub-clinical inflammation of insulin secreting cells that may be enhanced by immunization leading to insulin dependent diabetes.


"Based on our epidemiological data and previous animal studies, there appears to be a very tight window in which conditions are ideal to administer the first dose of common vaccinations," he says. "The next step is to verify this hypothesis with a large clinical trial involving humans, either in the United States or abroad.


"If the findings bear out, the benefit in the reduction of human suffering and associated health cam costs from Type 1 diabetes may be tremendous," says Dr. David Classen. It's estimated that more than $30 billion is spent annually in the U.S. alone to treat people with insulin-dependent diabetes.