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AIDS Trial Runs Short of Volunteers
By Eric Jansen
May 20, 1999
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Medical researchers in the Twin Cities are seeking 300 volunteers to test AIDSVAX, as part of the first nationwide trial of an AIDS vaccine on humans. But after nearly a year, researchers have only about one-third of the participants they want.

PETER JIRAK IS A 26-YEAR OLD MATH and computer science student at the University of Minnesota. At a Dinkytown deli between classes, he discusses why he decided to participate in an AIDS-vaccine trial. Jirak says he wants his kindergarten-age niece, Elizabeth, to grow up and regard AIDS the same way he thinks of polio.

"When my grandmother and her sister were little girls, they lost a bunch of childhood friends to polio," says Jirak. "My great-aunt still talks about all of the people she knows who got polio. I want, someday, for Elizabeth and her children to look back on HIV and AIDS the way I look at polio. I don't know anybody who's died of polio."

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Jirak says he believes a vaccine is the most likely way to end HIV. AIDSVAX is the first AIDS vaccine federal regulators have approved for large-scale testing in humans. The vaccine's developer, California-based VaxGen, hopes to enroll 5,000 volunteers by late summer. But after a year, the company has enrolled just half of its nationwide target. In the Twin Cities, researchers have enrolled only about 100 of their goal of 300, even with the help of occasional radio commercials.

"There are some people who are looking to be vaccinated, and they want certainty," says Kevin Sitter, HIV educator at Abbot Northwestern's Clinic 42, one of four Twin Cities vaccine-trial sites. "We can't provide certainty of whether they'll get the vaccine or the placebo, nor can we provide certainty that the vaccine works, or how well it works. So for people looking for certainty, it's too early."

Sitter sometimes literally beats the bushes for volunteers. His cabinet is filled with supplies he distributes in bars, bookstores, private parties and outdoor cruising spots. "They include condoms I can carry out and give to people. The condoms have the 'Lets Talk About Sex' and a 'Possible Vaccine for HIV' and then theres a condom inside people can use, and on the back is the 800-number that people can call."

Participants - mostly gay men - must be HIV negative, but must have engaged in unsafe sex in the past year. Women must either have contracted a sexually-transmitted disease in the past year, or have an HIV-positive partner.

Participants are injected with a vaccine or placebo three times in the first six months, then once every six months for another two-a-half years. They're checked regularly for side-effects and HIV status.

The Lead investigator at Regions Hospital in St. Paul, Dr. Keith Henry, says to show the vaccine's effectiveness, the three-year study assumes some participants will continue risky behavior. But Henry says the study encourages safe sex; safe-sex counseling is mandatory.

Peter Jirak considers himself very safe sexually, but says everyone takes occasional risks. "A lot of adults in their 20s and 30s, at some point, have driven a car when maybe they shouldn't have. They had one or two drinks too many. I think there are plenty of straight people who've had unprotected sex but haven't had a pregnancy."

Researchers say similar lapses account for about a three-percent HIV-infection rate, even with safe-sex education. If the infection rate is lower among those vaccinated than among those who get the placebo, researchers can show effectiveness. VaxGen says momentum is building and it will enroll enough participants for the trial to be scientifically valid.

Still, Most researchers are not pinning their hopes on AIDSVAX, which stimulates the body to produce antibodies to neutralize virus before it infects cells. AIDSVAX is synthesized from the outer shell of HIV. Many researchers theorize only a vaccine made from other parts of the virus, or live virus, can stimulate the immune system to kill infected cells. But researchers working on this trial say it will at least yield important information about the immune system, and how to draft volunteers for future vaccine trials.