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http://www.sltrib.com/2003/Jul/07242003/thursday/78096.asp

Herpes vaccine study finds few takers at the U.

By Carey Hamilton
The Salt Lake Tribune


    Researchers at 17 clinical sites nationwide, including the University of Utah, hope to help prevent the spread of herpes, which afflicts 45 million Americans, with an experimental vaccine.
    The study seeks 7,550 women between ages 18 and 30 to participate in the study. At the U., enrollment has been sluggish, possibly because of the misperception that volunteers will contract the virus.
    Researchers determine if the vaccine works by testing the blood for antibodies.
    "The patients do not get herpes," said Woody Spruance, an infectious-disease doctor with University of Utah Hospital and Clinics and the principal investigator of the study. "Enrollment has been slow. People who don't have diseases are harder to get involved rather than people who have diseases and are looking for a cure."
    The study is open only to women without herpes. So far, 24 people out of the targeted 500 have enrolled since January in the U. study. The women will be tracked for 20 months and receive routine blood withdrawals. About 50 women were turned away after tests detected the virus in their blood.
    Spruance said the vaccine could greatly affect what has become a huge public-health problem for which there is no cure.
    The disease can show up on the mouth or the genitals with clusters of blistery, open sores. Up to 80 percent of Americans have oral herpes, called Type 1, the most common form usually spread without sexual contact, according to Planned Parenthood Federation of America.
    Oral herpes is spread largely among children by saliva, through touching and other exchanges of fluids, Spruance said. You can also get Type 1 herpes in the genitals through oral sex. Type II is genital and is spread through sexual contact, potentially causing outbreaks in the vaginal area, penis and anus.
    Roughly one in four women have the virus in either type, and many people don't know they have it because they never had an outbreak or don't notice the symptoms, Spruance said.
    "Men are more likely to be aware of the disease because it's anatomically easier to see it," he said.
    Outbreaks can cause intense physical pain and take an emotional toll.
    For now, using condoms or abstaining from sex are the only ways to avoid getting infected from a partner with genital herpes. The vaccine, aimed at both types of herpes, may not be ready for several years because of the study and the required approval process by the Food and Drug Administration.
    Spruance and his team realize that some people may have a stigma associated with the vaccine. For example, they might think that by getting the vaccine they are admitting to being promiscuous or are not trusting their partner.
    "It's going to be hard to promote to some people because parents don't want to admit their children will have premarital sex," said Amber Thomas, a study coordinate.
    Rather, they hope that people will take the attitude that it's better to be safe than sorry. And they think parents would do their children a service by immunizing for herpes along with all the other standard shots.
    "People have to be educated," Spruance said. "If we thought it was impossible to administer these products, we wouldn't be doing the studies."
    The National Institute of Allergy and Infectious Diseases, in partnership with GlaxoSmithKline Biologicals, which would manufacture the vaccine, is leading the study. Researchers concluded from two previous clinical trials that the vaccine fails to work on the genital herpes virus in men. They theorized that the immune response to the vaccine delivers antibodies into the vaginal secretions of women, which might neutralize the virus. Men don't have the same secretions, and the virus comes into direct contact with the skin or nerves, Spruance said.
    Work also is being conducted at the U. on a vaccine for another sexually transmitted disease, the human papilloma virus, commonly called genital warts or HPV. Forty-five people have enrolled in the study. There is no requirement that participants must be HPV-free.
    Up to 20 million people in the United States have genital warts, but many go undetected, according to Planned Parenthood.
    In some cases, HPV is linked to cancers of the cervix, vulva, vagina, anus and penis. Women who have had HPV should have regular Pap smears to test for abnormal cells.
    For more information about the herpes study, call 801-585-9874. Participants are compensated for their time.
   chamilton@sltrib.com
   
   
   
 

 
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