January 15, 2004
About 7,500 women are being recruited at sites across the country to participate in the Herpevac Trial for Women. "It is an important area because one out of four women in the [United States] develop genital herpes," as do one out of five males, said Dr. Stanley A. Gall, principal investigator at University of Louisville, which hopes to begin recruiting participants after Feb. 1. According to CDC, as many as 1 million people nationwide become infected with genital herpes each year.
Because there is no foolproof way to prevent genital herpes and infected people harbor the virus forever, the ability to prevent infection with a vaccine would be significant, said Gall. If a women has herpes, her baby can suffer severe neurological damage or death if sores are present at delivery. A vaccine "could be a really important thing for the health care of women," Gall noted.
Study participants will receive three shots over a six-month period to protect against herpes and then will be tracked for several more months, said Dr. Kenneth Fife, principal investigator for the trial at the Indiana University Infectious Disease Research Group.
To participate in the study, women cannot have been exposed to herpes simplex virus (HSV) type 1 or 2. Genital herpes is typically caused by HSV-2. HSV-1 can also cause genital herpes but more commonly results in cold sores. Men are excluded from the trial because the vaccine was previously found to be ineffective in men, Fife said.
Finding the right people for the study -- co-sponsored by National Institute of Allergy and Infectious Diseases and GlaxoSmithKline Biologicals -- presents a considerable challenge because herpes is so common. Nationwide, about 3,000 people have been screened for the trial, but only 800 have been enrolled, said Gall. For more information about the trial, visit: www.herpesvaccine.nih.gov.