Human clinical trials involving investigational vaccines to prevent Hepatitis C are rare. In the fall of 2003 there was a first-ever study at Saint Louis University Center for Vaccine Development, and an earlier small study at Johns Hopkins School of Medicine.

Now a new trial - much larger than these two earlier studies - is about to start at Saint Louis University. Two hundred volunteers are needed, and SLU is the only site in the United States conducting this study.

“Sixteen years ago, the hepatitis C virus had not even been identified and now there are an estimated 170 million people around the world infected.” said Sharon Frey, M.D., professor of internal medicine in the division of infectious disease at Saint Louis University School of Medicine. “It is critical that we develop a vaccine to combat this growing health problem.”

The purpose of this research is to study the safety and effectiveness of the Chiron Corp.‘s investigational hepatitis vaccine. Although the Chiron vaccine has been given to people in previous studies, this is the first time the vaccine will be tested in humans with a different “adjuvant.” (A vaccine adjuvant is a chemical designed to help the body make a better response to vaccines.) Volunteers will be randomly assigned to receive one of the nine different combinations of hepatitis C virus vaccine and adjuvant.

“Officials at the Centers for Disease Control and Prevention believe that approximately 40,000 new cases of hepatitis C infections occur every year,” Frey said, “therefore a vaccine to prevent the infection would be an important breakthrough in controlling the spread of the hepatitis C virus.”

The study is being conducted by Saint Louis University’s Center for Vaccine Development (led by the division of infectious diseases and immunology) in collaboration with Saint Louis University Liver Center (led by the school’s division of gastroenterology and hepatology). This research is sponsored by the National Institutes of Health and Chiron Corp.

Hepatitis C virus is a blood-borne infection that causes approximately 10,000 deaths annually and is responsible for almost half of the 4,000 liver transplants each year. The CDC estimates medical and work-loss costs for hepatitis C at more than $600 million annually, excluding the costs of transplantation. It is believed that 2.7 million Americans have chronic infection with this virus.

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