Herpes Vaccine Study

Genital Herpes
Genital herpes is a sexually transmitted infection caused by the herpes simplex virus (HSV). There are two main types of the herpes simplex virus. HSV-1 most commonly causes oral infections (i.e., cold sores or fever blisters). HSV-2 is the most common cause of genital infections. In some cases, oral sex can lead to the transmission of HSV-2 to the genital area and HSV-2 to the oral area.

The Centers for Disease Control and Prevention estimates 45 million Americans (one out of every four adults) has genital herpes, and as many as 500,000 new cases occur every year. But about 80 percent of patients are unaware they have the virus and can transmit it to others. Some people have mild symptoms or none at all. For others, painful lesions in the genital area are signs of an initial outbreak. Within two to 10 days of exposure to the virus, small fluid-filled lesions appear in the genital area. The blisters eventually crust over and form a scab. The first episode may also be accompanied by fever, headache, muscle aches, swollen glands, painful urination, and, in women, vaginal discharge.

Once a person is infected with HSV, the virus settles in the body and becomes inactive. At any point in time, the virus can be reactivated, causing a recurrence of symptoms. Some people experience few recurrences while for others, the recurrences are more frequent. For most patients, recurrences tend to be more frequent during the first year after infection. After that, the recurrences tend to become less frequent with milder symptoms. Many people experience warning signs, like tingling or itching, just before the eruption of symptoms.

There are many medications to control or reduce the frequency of herpes symptoms. In addition, since the virus can be sexually transmitted, patients must take great care not to pass on the infection to an intimate partner. During outbreaks, sexual activity should be postponed until all lesions are healed. In symptom-free periods, latex condoms may help reduce the transmission of the virus.

Genital herpes infection is of greater concern for pregnant women. A woman who acquires genital herpes in the last three months of pregnancy can pass the virus onto the baby during vaginal delivery. Newborns with herpes are at high risk of death or developing severe brain damage from the virus.

A Vaccine for Herpes
Currently, there is no cure for genital herpes. However, researchers are studying a vaccine that may prevent infection with the virus. The “Herpevac Trial for Women” is sponsored by the National Institute of Allergy and Infectious Diseases and GlaxoSmithKline Biologicals. The study will enroll about 7,550 women through more than 20 sites across the country (a list of sites follows this research). To participate, women must be generally healthy, between 18 and 30 and test negative for both HSV-1 and HSV-2. Some of the participants will receive the herpes vaccine and others will receive an investigational hepatitis A vaccine. The vaccine type will be randomly assigned by computer. In the first six months, participants will receive three doses of the assigned vaccine. Then, the women will be followed with periodic visits and contacts for a total of 20 months.

Earlier studies with the vaccine showed the vaccine prevented infection in more than 70 percent of women with no signs of HSV-1 or HSV-2 infection. However, the vaccine did not prevent genital herpes in women with HSV-1 (the oral form) or in men. Side effects of the vaccine include soreness, redness or swelling at the injection site, tiredness, fatigue, headache and mild fever. In most cases, the symptoms last no more than 24 hours. For information about the study, log onto the study’s website at: http://www.niaid.nih.gov/dmid/stds/herpevac.

Herpevac Study Sites:
University of Alabama at Birmingham, Birmingham, AL
University of California, Los Angeles, Torrance, CA
University of Colorado, Denver, CO
Indiana University Infectious Diseases Research Group, Indianapolis, IN
Louisiana State University, New Orleans, LA
Johns Hopkins University, Baltimore, MD
University of Maryland, College Park, MD
St. Louis University, St. Louis, MO
University of Rochester, Rochester, NY
University of North Carolina, Chapel Hill, NC
University of North Carolina, Raleigh, NC
Cincinnati Children's Hospital Medical Center, Cincinnati, OH
Westover Heights Clinic, Portland, OR
Primary Physician's Research, Inc., Greenville Medical Center, Greenville, PA
Primary Physician's Research, Inc., Valley Women's Health, Monongahela, PA
Primary Physician's Research, Inc., Pittsburgh, PA
Primary Physician's Research, Inc., Wexford, PA (2 sites)
Baylor College of Medicine, Houston, TX
Center for Clinical Studies, Houston, TX
University of Utah, Salt Lake City, UT (4 sites)
University of Washington, Seattle, WA

For information about the vaccine or locations of the study, log on to the website at http://www.niaid.nih.gov/dmid/stds/herpevac

For general information on genital herpes:
American Social Health Association, PO Box 13827, Research Triangle Park, NC 27709, http://www.ashastd.org
Centers for Disease Control and Prevention, Division of Sexually Transmitted Diseases, http://www.cdc.gov/nchstp/dstd/HerpesInfo.htm, National Prevention Information Network, http://www.cdcnpin.org/scripts/index.asp, National STD Hotline (800) 227-8922
National Institute of Allergy and Infectious Diseases, http://www.niaid.nih.gov