SLU researchers lead herpes study

ST. LOUIS -- Researchers at Saint Louis University will lead a national four-year study into a possible vaccine to prevent genital herpes in women, SLU officials announced Wednesday.

The study, a follow-up to an earlier national study, is funded by the National Institutes of Health and GlaxoSmithKline Biologicals, developer of the proposed vaccine.

The study will involve 7,550 women and will be conducted at 16 U.S. sites, with Saint Louis University serving as the national coordinating site. SLU's Vaccine Center will enroll approximately 500 women.

Researchers believe the vaccine would be effective in women only. It would not cure herpes for those already infected but could lessen the amount of virus in the body, researchers said.

SLU will receive a $36.8 million grant, its largest ever, for its role in the study. If the vaccine proves effective, approval from the Food and Drug Administration could come in as early as six years, said Dr. Thomas Heineman, the study's principal investigator.

The Centers for Disease Control and Prevention estimates that 45 million American teenagers and adults are infected with the type 2 herpes virus, which is almost always spread during sexual contact. The other herpes simplex virus, type 1, is much more common and causes cold sores. However, it too can cause genital infections if spread through oral-genital contact.

"This is the largest clinical trial we've organized and has the potential for making a significant contribution to women's health," said Dr. Robert Belshe, SLU professor of internal medicine and the national chairman for the study.

Herpes is more than a nuisance, Heineman said.

"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," he said. Herpes can cause brain damage and even death in newborns.

Charles Ebel, co-author of the book "Managing Herpes" and a senior director for the American Social Health Association, said the vaccine could be a significant breakthrough.

"Even though it's not a slam dunk, it's a very exciting development because, for decades, developers have tried to bring along a vaccine that would work and this is the first one that shows signs of being effective," Ebel said.

In previous clinical trials, the vaccine was administered to more than 2,700 people between 18 and 45 years of age. About 73 percent of women who were free from infection at the beginning of the trials and who received the vaccine were protected against genital herpes.

The herpes virus produces small, painful, fluid-filled blisters on the skin and mucous membranes. The symptoms usually last one to two weeks. But the virus stays in the body after infection and may reactivate to cause new outbreaks.

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, SLU officials said.

------

On the Net:

http://medschool.slu.edu/vaccine/

American Social Health Association: http://www.ashastd.org/

GlaxoSmithKline: http://www.gsk.com/index.htm