Unsung 'heroes' help create AIDS vaccine

Researchers say they will need thousands of volunteers to test potential AIDS vaccines.

By Christy Feig
CNN Medical Unit

(CNN) - It was an editorial in the newspaper on an HIV vaccine trial in Atlanta, Georgia, that caught Steven Epstein's eye.

"I read all the reasons why people weren't signing up and it really bothered me, that people were choosing not to participate in the study for fear that they would get HIV," Epstein said.

So he signed up.

An advertisement in the paper was the impetus for Al Cotton to participate in an HIV vaccine trial.

"We're not going to be able to wipe out HIV with safe sex," he explained. "Having some way to keep people from being infected with it even when they're exposed is the only way I think HIV is going to get taken care of. It's the only way it's going to end and so that's why a vaccine is so important and that's one reason to be involved."

Volunteer Steven Epstein learned about the vaccine trials in a newspaper editorial.

As AIDS vaccines move through the research pipeline, it will take thousands of volunteers like Cotton and Epstein before researchers can be sure they have an effective vaccine.

But when it comes to HIV, both researchers and trial participants have concerns that aren't raised with other diseases.

"The conundrum with AIDS is (that) unlike chicken pox, AIDS is fatal," said Ezekiel Emanuel, a bioethicist at the National Institutes of Health.

Many people considering participating in vaccine trials are afraid of contracting HIV from the vaccine.

Researcher Mary Allen, of the National Institutes of Health, says those fears are overblown.

"The vaccines do not contain HIV, they cannot give anyone HIV. No one can get AIDS from these vaccines."

Nevertheless, when researchers design a vaccine trial, they rely on the fact that some volunteers are going to be exposed to the disease. It is the only way for scientists to determine whether the vaccine is effective.

The researchers don't intentionally expose volunteers, but instead select subjects who would likely be exposed to HIV because of their lifestyle.

Even so, researchers say it would be unethical to not counsel patients on strategies to avoid HIV infection, so they are given education and condoms.

Volunteer Al Cotton is taking part in an HIV vaccine trial because he feels it is the best hope for stopping the spread of AIDS.

The goal is to keep participants from relying on a vaccine they may not have been given.

"You have to realize that a third of the people are getting a placebo," explained Mark, another volunteer who asked not to share his last name, "and even if you don't get a placebo, they have no idea what level of protection you might be getting."

That point must be made very clear to all trial participants, Emanuel agreed.

All trial participants must sign an informed consent form, acknowledging they are aware of the risks of participating in the trial -- including the fact that they won't be completely protected.

So what happens when a volunteer does get infected during a trial?

Emanuel says there is no international consensus on this issue, primarily because treatment is incredibly expensive -- often costing more than $10,000 a year -- and must be taken indefinitely.

Difficult questions

The issue becomes complicated in places like Africa, Emanuel said, where the powerful HIV medicines available in the United States are not the standard of care.

"Just imagine you are in Africa," Emanuel said, "and you have some people infected and you give them full antiretroviral therapy. But what about their wife or neighbor who might get infected? Then you have a fairness issue. Should some get antiretrovirals because they're in the trial and others, because they are not in the trial, don't get them?"

The complicated questions can't be dodged by running all trials in the United States. The type of virus in the U.S. and Europe varies from the types in Africa, India, and China, so vaccines must be tested in many countries.

With only one AIDS vaccine in large-scale clinical trials, tens of thousands more volunteers will be needed before researchers can be confident an effective vaccine has been found.

"I think sometimes about the word 'hero,' said researcher Allen, "and how to me, it's an ordinary person in an extraordinary situation who does what needs to be done. And our volunteers are heroes."