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22 January 2004
Final Phase Trial For Herpes Vaccine

Around 25% of women in the United States has genital herpes. Symptoms are often subtle, and most people don't know they have herpes, but genital herpes is among the most common infectious diseases. This is why Mount Sinai School of Medicine has joined with the National Institute of Allergy and Infectious Diseases and GlaxoSmithKline Biologicals in the Herpevac Trial for Women. Healthy women aged 18-30 may be eligible to participate in the trial.

The herpes virus causes cold sores and genital herpes. Although thousands or millions of Americans have the disease, 90% are unaware of this infection. Even people who do not have visible symptoms can spread the disease. The disease burden is estimated at between $300 million to $1 billion per year in the US alone. There is no treatment that can eliminate the virus.

The Herpevac Trial for Women is investigating a promising vaccine to protect women against genital herpes. This vaccine does not contain live virus and cannot cause herpes infection.

It has passed preliminary testing for safety and effectiveness and is now in its final phase of clinical trials.

For this study, Mount Sinai and the more than 20 other sites involved in the trail are seeking to enroll approximately 7,550 women. The Herpevac Trial for Women is open to healthy females between the ages of 18 and 30 who are negative for both HSV-1 and HSV-2.

Women who are interested in volunteering for the clinical trial will receive a very accurate blood test that looks for antibodies (the immune system's response) to both HSV-1 and HSV-2. Participants can obtain results of the test by calling the Herpevac Trial for Women Test Result Hotline two weeks after having the blood drawn. In addition to providing results, this Hotline has trained counselors to answer questions about the test and test results so that women who test positive for herpes can understand what this means to them.

Volunteers will be randomly assigned to receive either the candidate herpes vaccine or and an investigational hepatitis A vaccine. Participants will receive three doses of either vaccine within the first six months of the trial and will be followed for a total of 20 months through periodic clinic visits and contacts.

If you are interested in participating, please contact Mount Sinai School of Medicine on 212-659-9045.


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