Current Research

Herpes Vaccine Study

Herpes is a common viral skin infection that is found worldwide. Herpes is caused by one of two viruses: Herpes simplex virus - type 1 (also called HSV-1) and Herpes simplex virus - type 2 (also called HSV-2). Although most cases of oral herpes are caused by HSV-1 and most cases of genital herpes are caused by HSV-2, either virus type can cause genital or oral disease.

In the USA, over 20 percent of the adult population has evidence in their blood of having been exposed to HSV-2; these individuals are known as seropositive. Among seropositive individuals, 20 percent - 50 percent will experience evidence of symptomatic disease. Symptoms can include painful genital sores as well as tenderness and burning in the genital area. HSV-2 seropositive individuals are at risk of spreading this infection to their sexual partners or, if they are pregnant, to their newborn at the time of delivery. Individuals diagnosed with genital herpes may also undergo physical and psychological suffering that can diminish their quality of life.

There is no cure for genital herpes and effective vaccines to control the epidemic spread of HSV-2 are needed.

The Mount Sinai School of Medicine (Department of Obstetrics, Gynecology, and Reproductive Science) has been selected as a site for a multi-centered research study to evaluate the safety and effectiveness of a vaccine to prevent genital herpes disease. The study is funded by a partnership between the National Institutes of Health and GlaxoSmithKline, the vaccine manufacturer. Nationwide, approximately 7,550 women in over 20 medical centers will take part in this study and about 500 of these subjects will be here at Mount Sinai . The investigational vaccine being tested does not contain live virus and cannot cause genital herpes.

Participants in this study must be healthy women between the ages of 18 and 30 with no history of either oral or genital herpes. The trial is only for women because earlier studies suggest that the vaccine may reduce the risk of herpes in women but not men. Two phase III clinical studies of this vaccine have been completed and have included over 2,700 women. In both of these clinical trials, the primary endpoints were not met. However, in both studies, the vaccine prevented genital herpes disease in approximately 75 percent of women who were free of both HSV-1 and HSV-2 infection at the beginning of the study.

For more information:

Tel: (212) 241-8902
E-mail: herpes-vaccine@mssm.edu
Web site: http://www.herpesvaccine.nih.gov

GCO # 03-0956; IRB approved through 8/31/05

Patient information slide show*

* PPS files are PowerPoint Presentations and require Microsoft PowerPoint. If you do not have PowerPoint, you may download the PowerPoint Viewer. Windows version | Mac version