Major vaccine trial launched in women.

2002 DEC 18 - (NewsRx.com & NewsRx.net) -- A pivotal efficacy trial of an experimental vaccine designed to prevent genital herpes in women has begun enrolling volunteers.

The study will determine the vaccine's ability to prevent genital herpes disease in women who are free of two common types of herpes simplex viruses (HSV): HSV-1 and HSV-2. The trial will eventually enroll 7550 women in at least 16 sites in the United States. It is the result of a partnership between the National Institute of Allergy and Infectious Diseases (NIAID) and the vaccine's manufacturer, GlaxoSmithKline Biologicals (GSK), headquartered in Belgium.

"This vaccine trial is an excellent example of a mutually beneficial collaboration between the public and private sectors," said NIAID Director Anthony S. Fauci, MD. "More than 1 million new cases of genital herpes are diagnosed in the United States each year. The physical and psychological toll taken by this sexually transmitted disease is considerable. Successful public-private collaborations such as this one will take us closer to our goal of reducing the spread of genital herpes."

Previous efficacy trials of the GSK vaccine were conducted in smaller numbers of men and women who did not have genital herpes but whose sexual partners were known to be infected. For reasons still not well understood, the vaccine prevented herpes disease in more than 70% of HSV-1 and HSV-2 negative women but had no clear effect in men. The results of these earlier phase III trials are reported in the New England Journal of Medicine.

Finding thousands of HSV-negative women for the new trial will be a significant challenge, said Pamela McInnes, DDS, MSc(Dent.), deputy director of NIAID's Division of Microbiology and Infectious Diseases. Between 50% and 80% of Americans are infected with HSV-1, typically during childhood, and about 1 in 5 people over age 12 is infected ...