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U. Washington researchers on brink of HIV vaccine

By Kathleen Belew

The Daily (U. Washington)
05/23/2001

(U-WIRE) SEATTLE -- Nine years ago Paul Verano lost his partner to a devastating disease which remains an epidemic in the United States and worldwide -- AIDS.

Now Verano works as a recruitment coordinator for a study searching for a vaccine to save millions of others from the same fate. Researchers at the University of Washington Medical Center's HIV Prevention Trials Unit (HPTU), including Verano, are currently in the advanced stages of testing one AIDS vaccine. If all goes well, the vaccine may be approved and marketable by this time next year.

The vaccine, known as gp120, is a protein located on the outer coating of the HIV virus. The treatment works by teaching the immune system to recognize the virus as foreign. This way the body can either rid itself of the disease or live with the virus while keeping it in check.

Lately, rising rates of HIV and other sexually transmitted diseases (STDs) have caused concern among public health officials in King County. Susan Buskin, an epidemiologist for Seattle and King County Public Health, said "other cohorts" tipped off officials that HIV rates might be rising. Sudden increases in STDs, even less serious ones, indicate more unprotected sex. Unprotected sex implies the spread of more serious public health concerns, such as HIV. On April 29 of this year, Buskin's department recommended that gay men in King County be routinely tested for STDs, citing a resurgence of syphilis. Not only does HIV spread through lifestyles in which STDs are prevalent, but having an STD greatly increases vulnerability to the disease.

A resurgence of unprotected sex worries Verano. He fears a lack of community interest in the AIDS epidemic.

"We've talked about it so much that people are sick of the message," Verano said of the AIDS prevention effort. "It's like pulling teeth in some of these communities."

King County, he said, has produced a lot of community volunteers, outshining major cities like New York. Verano said developing the vaccine depends on the participation of volunteers in the study.

Like all vaccines tested, gp120 has gone through several stages of research. In phase one, 100 people at no risk for HIV are exposed to the vaccine to ensure it does not harm the body. Clinicians watch for negative effects on the liver and kidneys, as well on red and white blood cells.

Phase two involves people with a 30-percent to 50-percent risk of contracting the virus, and continues to check for safety. This phase tries to determine the best amount of vaccine to administer.

Phase three, where gp120 is now, is a two-year cycle designed to determine whether the vaccine -- by this point deemed safe -- is effective in preventing HIV infection. The roughly 900 volunteers for the third phase of testing are at high risk for infection. Half of the subjects in every phase are given a placebo -- a substance that does not contain the vaccine -- to be sure effects of the medicine are not psychological.

Of the final phase volunteers, 1 percent to 2 percent should statistically contract the virus. The vaccine's effectiveness will be determined by the lowering of that percentage, and by how much.

Serious ethical questions have become a major concern to vaccine researchers, according to Verano. For example, it would be unethical to tell the vaccinated volunteers to have unprotected sex or share needles.

"We can't just say to people, 'Go be unsafe,'" Verano said.

Also, there are ethical questions about whether to market the vaccine even if it is proven effective. VaxGen took over funding the gp120 vaccine project when the National Institute of Health (NIH) decided the idea was too risky. VaxGen may receive permission from the Federal Food and Drug Administration and the NIH to market the vaccine if it is proven to be 30-percent effective or better.

However, if the vaccine is only 30-percent effective, marketing it could have some serious repercussions, according to Verano.

"The problem would be that the people would start having unsafe sex, thinking they were protected," he said.

All in all, even if the vaccine is approved from phase three, it will take time to distribute it to the people who need it most.

"We don't think a vaccine is going to be out on the market tomorrow," said Dennis Torres, HPTU community educator.

Several other HIV vaccines are also being tested. In the office next door to the HPTU, the Fred Hutchinson Cancer Research Center and UW's Vaccine Trials Unit (VTU) is in the process of phase-two testing on another method.

This method combines the gp120 protein with a live canary pox, a virus that does not reproduce or cause disease in humans. The method will theoretically give the cells instructions to make proteins, generating the autoimmune response.

Buskin would trade her livelihood as a public health official for a vaccine to eradicate the AIDS epidemic.

"It would be a dream come true if there was a vaccine that was affordable," Buskin said. "That's my dream, to be out of a job."

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