Saint Louis University, along with the National Institute of Health, announced a $36.8 million clinical trial Wednesday to test a new herpes vaccine.
“The HERPEVAC Trial for Women” will start this month, with the School of Medicine’s Center for Vaccine Development leading the study. The nationwide herpes vaccination trial is being conducted across the United States in 16 cites, in university student health services, sexually transmitted disease clinics and family planning clinics. HERPEVAC is the largest clinical trial SLU has organized in its 184-year history.
“We’re delighted that the NIH and the vaccine developer, GlaxoSmithKilne Biologicals, have chosen SLU to lead this important public health effort,” said Robert Belshe, the national study chair. Belshe is an Adorjan professor of internal medicine and director of the Center for Vaccine Development.
The purpose of the HERPEVAC study is to assess whether a new vaccine is safe and effective in preventing genital herpes symptoms in young women who are not infected with herpes simplex virus. The trial involves 7,550 women volunteers, 500 of them from the St. Louis area. To be eligible, one must be a woman between 18-30 years old, be sexually active and not previously infected with either herpes simplex one (oral) or two (genital) virus. Half of the volunteers in the study will receive the new herpes vaccine, and the other half will receive a vaccine made by GlaxoSmithKline to prevent hepatitis A. The hepatitis A vaccine is being used as the control for the trial. The persons receiving the hepatitis A vaccine will be protected against hepatitis A but not herpes. vaccine to fight the disease would represent a major public health triumph.
The study’s principle investigator, Thomas Heineman, M.D., Ph.D., said, “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 at birth.” Hieneman is an associate professor at SLU’s School of Medicine.
Herpes is a sexually transmitted disease. Symptoms include genital sores as well as tenderness in the genital area, but infection does not always produce symptoms. The HSV has the ability to establish latency during the life of its host. Therefore, the infected suffer reoccurring attacks as often as once a month. The virus can also be transmitted during pregnancy from the mother to the infant.
In previous clinical trials, the genital herpes vaccine was administered to more than 2,700 participants between 18 and 45 years of age. Studies previously conducted indicated that approximately 73 percent of women who were free from HSV-1 and HSV-2 infections at the beginning of the study and received the vaccine were protected against the herpes disease.
Bleshe said “This clinical trail … has the potential for making a significant contribution to women’s health.”
Participation in the study involves eight visits to the SLU center for Vaccine Development over a 20-month period. Those interested in participating in the study may call the Center at 977-6333.