Over 35 medical centres across the United States are participating in a nationwide efficacy trial of an investigational genital herpes vaccine that may prevent herpes infection in women. The investigational vaccine was well tolerated and appears to have demonstrated clinical benefit in preliminary testing and is now in a further clinical trial in the United States, the Herpevac Trial for Women.

The trial is the result of a collaboration between the National Institute of Allergy and Infectious Diseases (NIAID), a component of the US National Institutes of Health (NIH), part of the Department of Health and Human Services, and the manufacturer of the vaccine, GlaxoSmithKline Biologicals (GSK).

GSK Biologicals has completed two previous phase III clinical studies of the candidate vaccine in over 2,700 people aged between 18 and 45 years, all of whom had partners with genital herpes disease. Approximately 73% of women who were free of HSV-1 and HSV-2 infection at the beginning of the trials and who received the vaccine were protected against genital herpes disease. 1

These two earlier studies were designed to evaluate vaccine efficacy in men and women. No efficacy was shown in males and for this reason the Herpevac Trial for Women has been initiated to confirm the results in women.

The NIH is currently recruiting women between the age of 18 and 30 who are free from both HSV-1 and HSV-2 to participate in the Herpevac trial. The trial is being conducted in 35 sites across the United States and approximately 7,550 women will be enrolled and randomly assigned to receive either the investigational vaccine or an investigational hepatitis A vaccine. "Potential volunteers need to know that the trial vaccine cannot cause herpes." says the lead study investigator Dr Robert B. Belshe. He adds "The Herpevac Trial for Women is leading the way in the development of a vaccine that may protect women against the risks associated with genital herpes. An effective vaccine might help slow the spread of the disease." Women who participate in the trial will gain free access to the vaccine which may protect them from herpes and will be making a valuable contribution to medical research and the future of women's health. Prospective participants should visit www.herpesvaccine.nih.gov for further information and a list of trial sites and www.herpeshelp.com for information about genital herpes.

The Herpevac Trial for Women is being co-ordinated by the lead study investigator Robert B. Belshe, M.D., Director of the Center for Vaccine Development at the Saint Louis University School of Medicine and Principal Investigator of the St. Louis Vaccine Trial and Evaluation Unit (VTEU). He comments, "Although antiviral drugs can treat and help prevent herpes outbreaks, the virus can't be eliminated once it enters the body. An effective vaccine could break the chain of transmission by preventing infection altogether," he adds.

References

1. Stanberry LR, et al. Glycoprotein-D-Adjuvant Vaccine to Prevent Genital Herpes. N Engl J Med 2002; 347:1652-61