Wednesday, February 25, 2004

Vaccine testing short of subjects

Most volunteers already have form of herpes

By Matt Leingang
The Cincinnati Enquirer

A major herpes vaccine trial for women is off to a slow start at medical centers in the United States - including one in Cincinnati - because researchers can't find enough women without the virus.

The National Institutes of Health, which announced the trial at the end of 2002, seeks to enroll 7,500 women in at least 20 sites to determine the experimental vaccine's ability to prevent genital herpes.

Cincinnati Children's Hospital Medical Center is participating in a nationwide study of a vaccine to help stop transmission of genital herpes in women.

Who is eligible? Healthy women age 18-30 who have not been infected with oral herpes or genital herpes.

How does the study work? Nine scheduled visits over 20 months. Once enrolled in the study, participants are randomly assigned to one of two study groups. Half receive the herpes vaccine; half receive an experimental vaccine for hepatitis A - this is the control group. Blood and urine will be collected from both. You do not have to be sexually active to participate in the trial. The vaccine's success will be measured by how well your body builds up immunity - the presence of infection-fighting antibodies and T-cells in the blood.

Will I get paid? Yes - $30 will be given for time and travel at each scheduled visit and an additional $200 will be given to all that finish the study.

Could the vaccine actually cause herpes? The vaccine formulation used in this trial contains no live or infectious virus.

Is it safe? The vaccine has a good safety record. There are some reported side effects, including soreness, redness, or swelling in the injection site (upper arm).

To participate: Call Children's Hospital at (513) 636-7699.

The vaccine, made by GlaxoSmithKline Biologicals, could prove to be the first vaccine of any sort to prevent a sexually transmitted disease. Early studies in women show that the vaccine reduces their risk of contracting genital herpes by about 70 percent.

But with the enrollment period scheduled to end this summer, just 950 women in the United States are participating. At Cincinnati Children's Hospital Medical Center, which has a goal of enrolling 500 subjects, researchers have 84.

Progress has been slow because the trial requires a rare population of women - those who have never been infected with genital herpes or oral herpes, both of which are incredibly common.

Genital herpes alone affects nearly one in four women in the United States. The virus can cause uncomfortable, even painful, flare-ups of warts in the genital area.

Officials involved in the herpes trial say the enrollment period will be extended another year and more testing sites are being added. Men are excluded from the trial because the vaccine, for reasons that are not understood, is ineffective for them.

"This trial is a huge undertaking, one of the biggest NIH studies ever, and I knew it would be hard (to get enough participants). But it's much harder than I thought," said Dr. David Bernstein, director of the division of infectious diseases at Children's Hospital.

Actually, women are coming forward, Bernstein said. Children's Hospital has screened about 300 volunteers. But most have been turned away after blood tests revealed that these women have oral herpes or genital herpes.

Symptoms can be so mild or non-existent that many people aren't aware that they have forms of herpes, making transmission all the more likely. The rate of genital herpes, for example, has increased 30 percent over the past three decades.

Elise Allen, a 21-year-old senior at Miami University, volunteered for the study in October after doctors assured her that the vaccine could not cause her to be infected with herpes - it doesn't use a live virus.

"Once I got over that, I said, 'Yeah, let's do it.' It's for a good cause," Allen said.

Recruiters are looking for participants at college health fairs, including one at Northern Kentucky University next week, and by placing advertisements in local newspapers. Children's Hospital is planning a television commercial later this year.

The trial requires healthy women aged 18-30 who do not have herpes simplex virus-1, which is the "oral herpes" associated with cold sores, or herpes simplex virus-2, commonly called "genital herpes."

About 68 percent of Americans ages 12-70 have oral herpes, which can be spread from person to person much like a cold or flu, and 21.9 percent of people older than 12 have genital herpes, which is usually spread sexually, according to a 1997 report in the New England Journal of Medicine.

The consequences of genital herpes can be serious, so finding an effective vaccine to prevent infection in women would have huge benefits for public health, said Dr. Judy Falloon, medical officer with the National Institute of Allergy and Infectious Diseases.

For example, pregnant women who have an outbreak of genital herpes at the time of delivery can transmit the virus to their babies, causing severe neurological damage or death if sores are present when it's time to deliver the child.

About 2,000 mother-to-child transmissions occur in the United States each year, Bernstein said.

Also, the herpes virus has been identified as a risk factor for the spread of HIV/AIDS in adults.

If the experimental vaccine is ever approved by the U.S. Food and Drug Administration, the target population could be girls ages 10 to 12, Bernstein said.

"Not because we want them to have sex, but they would be reaching an age when they might - and it's our obligation to do everything we can to prevent the transmission of sexually transmitted diseases," Bernstein said.


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