HIV vaccine research advances at KUMC

Scientist hopes FDA will OK trials on humans

Because of the muscle spasms, numbness, vomiting, irritable bowel syndrome, fatigue, sore throats and fevers, there were times during the past 19 years when Sandy Swartz didn’t take her HIV medication.

“The side effects are so bad, it wasn’t worth taking the drugs,” said Swartz, a client of the Douglas County AIDS Project. “If all you can do is get out of bed, go to the bathroom, get something to eat and fall asleep on the couch watching TV, I don’t consider that a quality of life I want to accept for any length of time.”

Bill Narayan knows the side effects, too, and thinks he has a way to get a handle on them — and to quash the spread of HIV in infected patients.

The Kansas University Medical Center researcher has been testing a vaccine that could be injected in HIV-positive humans to stop the spread of the virus that causes AIDS.

He’s been testing the vaccine, made from the DNA of HIV, on a virus model in monkeys for two years, and now he is hoping to receive funding in the next two months that would allow the vaccine to be developed for humans.

How it’s different

“What we’ve found is the DNA was very effective in preventing the spread of the disease,” Narayan said. “It has to stay in low gear. It can’t get in high gear.”

The vaccine mimics the blueprint of HIV, but without the genes that cause the virus to replicate. It initiates a response from the immune system researchers hope is enough to keep the virus in check.

Other researchers have combined portions of HIV with other DNA bases to form similar vaccines. Narayan’s project is unique in that it uses the base of HIV with the replication portions removed, which he thinks will make it more effective.

Sandy Swartz, of Topeka, sorts through the multitude of medications she takes for HIV. Swartz has been HIV-positive for 19 years, suffering a variety of side effects throughout the years. A Kansas University Medical Center researcher is working on a vaccine that would battle HIV in people infected with the virus that causes AIDS.

“We’re using HIV to fight itself,” he said.

Narayan has tested the vaccine in a model of HIV that infects macaque monkeys, using his continual funding from the National Institutes of Health.

He’s hoping to hear news on another NIH grant soon. That $15 million grant would provide financing to develop the monkey model for humans. Then, the vaccine would require approval from the U.S. Food and Drug Administration for clinical trials in humans, a process that probably wouldn’t start for at least two years.

Benefits

“We will not have any problems securing volunteers for this,” Narayan said. “Our problems will come on whether the FDA will allow it, and I can’t see why they wouldn’t, but who knows?”

The benefits for the vaccine over traditional drug therapies are the lack of side effects, effectiveness and lower cost. Drugs can cost HIV sufferers $25,000 a year, while a year’s worth of booster shots would cost less than $100.

Narayan also plans to test his vaccine to see whether it is effective in strains of HIV that have developed in other continents.

If a clinical trial for treatment is successful, the vaccine could be used to prevent HIV in those who engage in high-risk behaviors such as intravenous drug use and promiscuous sex.

Narayan ran into a roadblock several years ago with the FDA when he proposed a clinical trial on a preventive vaccine. That vaccine used a live strain of HIV capable of replication, and FDA officials said it wouldn’t pursue the trials because of the risk someone could be infected.

Hope for some

“Our monkey data suggests so far the vaccine will work prophylactically,” he said. “It’s just the emotional impact of it — the FDA is concerned. These people are just incredible. Here’s this damn virus that’s killing millions of people and they’re concerned about what if somebody should get sick from this vaccine — it’s one in a million.”

The 49-year-old Swartz, who lives in Topeka, takes news of a vaccine development with skepticism. She has heard of too many potential cures over the years.

“I don’t believe any vaccine will really help me,” she said. “They say a vaccine might help people a couple decades from now — so why do they even tell us about it now?”

But Swartz, who contracted the virus from a boyfriend, admits that living with HIV for 19 years and AIDS for 12 years has made her cynical. She said she was sure a clinical trial would draw plenty of volunteers.

“I’d imagine so,” she said. “If this was 10 years back, I might have tried it, too.”