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.