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Archive for Sunday, September 1, 2002

Scientist expects FDA to approve clinical trials

September 1, 2002

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— Opendra "Bill" Narayan thinks he's found a vaccine for HIV.

Of course, he's thought before that he had a sure-fire way to end the virus that causes AIDS, and the federal Food and Drug Administration wasn't interested.

This time around, when Narayan takes his vaccine to the federal government for clinical trials later this year, he's expecting approval.

"I don't see how they can say no," he said.

Narayan, a professor and researcher at Kansas University Medical Center, has been studying HIV for 20 years. For most of that time, his research has been financed by the National Institutes of Health.

Now, he thinks he's turned the corner to finding a vaccine to protect people from the virus, which has infected about 40 million people worldwide.

The research that led to his vaccine began in 1995, when Narayan and his team of about 15 researchers developed what he called a "monster virus" dubbed "SHIV-KU," because it's a hybrid of the monkey and human versions of HIV.

"We figured if we could stop the virus with a vaccine, we could stop HIV," he said.

Narayan then developed his first vaccine for HIV. It was a "live vaccine" similar to many vaccines that expose a person to small amounts of a virus to prepare their immune systems to battle the real illness.

It worked

The vaccine worked in macaque monkeys exposed to the AIDS-causing virus. In fact, now five years after they were exposed, some of the monkeys have no trace of HIV at all.

"It was beyond our wildest hope," Narayan said.

Last year, he asked for FDA approval to begin clinical human trials, but the agency questioned whether the live virus could cause HIV in humans. Narayan said he couldn't make any promises.

"FDA is the ultra-most conservative agency in the United States government," he said. "We knew the vaccine was safe. We knew it protected monkeys. But the FDA just balked."

A spokeswoman for the FDA declined to comment on Narayan's research or the process for approving clinical trials.

Narayan also approached governments of several African countries about clinical tests.

"They said, 'We no longer want to be America's guinea pigs,'" he said.

So Narayan went back to the lab and developed a new vaccine derived from the DNA of HIV. Once in a body, the vaccine can replicate only twice, not enough to cause harmful effects of HIV.

Narayan tested the new vaccine on macaques this spring.

"That vaccine is still working," he said. "It doesn't work as well as the live virus, but we're going to run with it."

The new vaccine only prevents HIV infections, unlike the old vaccine, which eliminated HIV from patients who already were infected.

Narayan acknowledges other vaccine tests have been successful after a few months and the vaccine's effectiveness later fails. But he still plans to publish his findings and approach the FDA for clinical trials.

Other vaccines

Steve Wakefield, director of community outreach for the national HIV Vaccine Trials Network, said there were about 10 HIV vaccine trials being done in the United States, and about 10 more in other countries.

"If we have (the vaccine) in a vial today, it will be at least seven years before we know for sure the vaccine works and another two years for widespread distribution," Wakefield said.

He said HIV had become the top priority for vaccine researchers.

"There certainly are more vaccines in the pipeline because of the continued commitment of NIH," he said. "The sense of urgency to find a vaccine isn't the same (with other diseases) because many of those things have become treatable over the years."

Narayan came to KU in 1993 from Johns Hopkins University. A native of Guyana, he was trained as a large-animal veterinarian and made the switch to working on HIV when he studied its equivalent in sheep more than 20 years ago.

Narayan, 65, said he had no plans to end his HIV research. But he's not driven by the desire to help people. He's driven by the challenge of finding a vaccine that has eluded researchers for years, and by his love of his work.

"I'm not doing it because it's great for humanity," he said. "We do it because we're human beings and we like to have fun. I'm just lucky as hell if it works."

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