FRIDAY, May 18, 2001 (HealthDayNews) -- Antoinette Jenkins, a single mom from the Bronx, N.Y, is doing her part to rid the world of AIDS.
She's not a doctor or a scientist or a government official. Rather, Jenkins is a volunteer -- one of 12,000 Americans who've participated in tests of various possible vaccines against HIV, the infection that leads to full-blown AIDS.
"I just want to be helpful, hopefully, down the line to somebody else," Jenkins says. "I've had family members with HIV
and friends who've died from AIDS. I just want to help. You have to start somewhere."
AIDS has killed more than 16 million people worldwide, but scientists at the National Institutes of Health, who've been struggling to find a way to stop the spread of this fatal disease, seem confident they're on the brink of something big.
"There's never been a more optimistic time than right now in terms of our ability to achieve success," says Peggy Johnston, assistant director for HIV/AIDS vaccines at NIH.
And for that, the generals in the battle against AIDS want to thank the troops. The government has designated today as HIV Vaccine Awareness Day, to recognize the role ordinary people play in this effort and to encourage more people to participate as testing of potential vaccines continues.
"This is not a problem that's going to be solved by academics or scientists or governments alone," Johnston says. "It really takes everyone chipping in and working side by side."
"I think of all the smart people out there working on this, and I've got to believe we can outwit this virus," she says. "It takes time, it takes money, and it takes a lot of people working together."
"The people in the community are the real heroes," she adds.
U.S. researchers have been testing various vaccines in people since the late 1980s, with more than two dozen possibilities evaluated so far, Johnston says. In the last three fiscal years, NIH has spent a reported $695.5 million on HIV vaccine research, with an additional $356.6 million estimated for this year.
If a potential vaccine has shown success in lab and animal testing, it's tested in people to see whether it causes side effects, whether it can stimulate an immune response and what the most appropriate dosage might be. Eventually, studies check how well it actually protects against HIV.
Known as clinical trials, tests start with a small group of people, with the number increasing as the testing proceeds through various phases.
You do not need to be considered at-risk for contracting AIDS to participate in the studies. In fact, organizers say all types of people have volunteered for the HIV vaccine tests -- men, women, all sexual orientations, all races. But you generally must be in good health and between 18 and 60 years of age.
However, in the final stage of testing a vaccine, the participant pool must include people at risk, Johnston says.
"People [who participate] are counseled frequently about how not to get infected," she says. "But we know that, even with this counseling, some people take risks. But that's how we know [whether the vaccine protects against HIV]."
"We actually need some of them to [take risks], or the trial won't work," she adds.
Developing a vaccine that does work has become paramount to world health experts, who now consider a vaccine the best --perhaps only -- way to stem the spread of this incurable disease.
The number of Americans contracting AIDS and dying from it has begun to decline, but worldwide the epidemic is accelerating. New drugs can stall the progress of HIV infection, but in poorer parts of the world where the disease is rampant, few people can afford the drugs.
That's made the hunt for a vaccine all the more intense. On this day four years ago, in fact, former President Bill Clinton challenged American researchers to develop a vaccine by 2007.
One potential vaccine now is in the final phase of testing in people, Johnston says, to see whether it truly protects against HIV. She expects results no later than late next year. And a second vaccine should be ready for similar testing by then, she says.
"If the first vaccine is successful, we certainly will make it," she says, referring to Clinton's challenge. "If the second one is, then we have a good chance of making it."
"But there's enough in the pipeline that many people are confident we'll find something within this decade," she adds.
George Romey, a 41-year-old gay man who lives in New York City and participates in the vaccine testing program, says he realizes a vaccine is "the only way this [disease] will go away."
"Sexual behavior is very hard to regulate," Romey says. "You can't just say, 'Use a condom,' and expect that'll be the final solution."
Helping scientists develop an effective vaccine is one way, he says, "to do something for the good of all."
Just who would use a vaccine against AIDS, Johnston says, probably would depend on its safety, side effects and cost.
"First it will depend on the country," she says. "Where there's a lot of prevalence of HIV, and individuals are likely to be exposed, then one can see that a vaccine might be widely used, widely needed."
"In a country like the U.S., where the incidence is pretty much confined to individuals with identified high-risk behaviors, then it might not be as broadly used, and more restricted to high-risk groups," she says.
Although medical experts say anyone can contract AIDS, certain behaviors put people at more risk. Those include sharing needles during intravenous drug use, having unprotected sex with multiple partners, having unprotected sex with someone who's HIV-positive, having another sexually transmitted disease or having had a blood transfusion before April of 1985, when standard screening for HIV began.
Volunteers who participate in the testing of vaccines face no increased risk of contracting AIDS from the testing, Johnston says.
"People are not intentionally exposed to HIV, nor is there any chance that the vaccine itself would cause HIV or AIDS," she says.
But they do face other possible hardships. Jenkins, the volunteer from the Bronx, says she can't have babies while in the study and for a certain time after.
"All female volunteers of childbearing age are advised to not get pregnant [because of] the uncertainty of what the effect of the vaccine would be on the developing fetus," Johnston says.
Toxicology studies would be done on vaccines before large-scale testing, she says, but not when a product first goes into the testing process.
And some people might have "a lot of explaining" to do if they try to get health insurance or life insurance or donate blood, she says, because sometimes the vaccine itself produces a false-positive result on a standard test for AIDS.
But the government provides study participants with a special ID card and a toll-free number for verification of their participation in a vaccine test and proof that the vaccine caused the incorrect test result, she says.
"We're extremely appreciative of all the volunteers," Johnston says.
What To Do
For more information on AIDS vaccines, visit the National Institute of Allergy and Infectious Diseases.
To see what clinical trials are available, try Veritas Medicine. For specific information about testing procedures and requirements, visit the HIV Vaccine Trials Network. For details on enrolling, call the Clinical Trials Information Service at 1-800-874-2572.
For general information about AIDS, check out the
