"We're delighted that the NIH and the vaccine developer, GlaxoSmithKline Biologicals, have chosen Saint Louis University to lead this important public health effort," said Robert Belshe, M.D., the national study chair and Adorjan professor of internal medicine and director of the Center for Vaccine Development at Saint Louis University School of Medicine. "This is the largest clinical trial we've organized and has the potential for making a significant contribution to women's health."
The study will be conducted at 16 U.S. sites, with Saint Louis University as the national coordinating site. Saint Louis University's Vaccine Center will enroll approximately 500 people.
"The purpose of this study is to determine the ability of the investigational vaccine to prevent genital herpes in women," said Thomas Heineman, M.D., Ph.D., principal investigator for the study at Saint Louis University and an associate professor at Saint Louis University School of Medicine. "Herpes is one of the most common infections in humans and a serious health problem. Although many people infected with herpes simplex virus have no symptoms, herpes infections can be a major source of stress and discomfort and can cause serious disease in newborns who are infected at birth."
The herpes virus produces small, painful, fluid-filled blisters on the skin and mucous membranes. The symptoms usually last one to two weeks. The virus, however, stays in the body after infection and may reactivate to cause new outbreaks. These outbreaks may happen many times a year and sometimes occur following illness, physical or emotional stress, or exposure to sunlight or certain foods or medications.
In previous clinical trials, GlaxoSmithKline Biological's candidate genital herpes vaccine has been administered to more than 2,700 people between 18 and 45 years of age. Previous studies indicated that approximately 73 percent of women who were free from HSV-1 and HSV-2 infection at the beginning of the trials and who received the vaccine were protected against genital herpes disease.
Established in 1836, Saint Louis University School of Medicine has the distinction of awarding the first M.D. degree west of the Mississippi River. Saint Louis University School of Medicine is a pioneer in geriatric medicine, organ transplantation, chronic disease prevention, cardiovascular disease, neurosciences and vaccine research, among others. The School of Medicine trains physicians and biomedical scientists, conducts medical research, and provides health services on a local, national and international level.