or nearly 20 years, Michael Keefer, associate professor of medicine, has worked to identify one of the most sought-after weapons in the fight against the AIDS pandemic--an HIV vaccine. As director of the HIV Vaccine Trials Unit at the Medical Center, one of 30 clinical study sites in the world sponsored by the National Institutes of Health (NIH), Keefer oversees early phase trials of potential HIV vaccines and also works to educate the public on the importance of vaccine research. In observance of the eighth annual National HIV Vaccine Awareness Day on May 18, Keefer discusses the need for more volunteers and the local contributions made to HIV research.
What role does the HIV Vaccine Trials Unit play in the search for a vaccine?
The unit is one of five original sites in NIH's clinical trials network. Since 1988, researchers here have investigated potential preventive HIV vaccines through studies involving more than 800 local volunteers. We primarily perform early, phase-one trials, looking for those vaccines that create positive immune responses in participants to determine if large-scale licensure studies are warranted.
How close are researchers to a breakthrough?
Science is moving fast, and researchers are learning more and more each day. In fact, the progress made in the fight again HIV has been remarkable-perhaps more so than for any other infectious disease. But even under the best conditions, it takes about a decade on average to develop any kind of vaccine.
Currently, there is one HIV vaccine in the advanced phase of clinical trials in Thailand and another newer one that has just moved into large studies in participants who are at high-risk for HIV in the United States, Caribbean, and South America. The immune responses we're seeing from the latter are pretty exciting, and the work we have done over the past five years in Rochester has led directly to that. If all goes well, we could have at least a partially effective vaccine--one that works for portions of the population--within the next 5 to 10 years.
However, even as researchers continue to make progress, there's always likely to be something more promising in the early stages of development that is poised to start down the decade-long pipeline. This search for the ultimate vaccine-the one that will eradicate AIDS from the world--will be a continuous process and realistically could go on for decades.
What are some common misperceptions about participating in HIV vaccine trials?
Often people assume participants need to be HIV-infected or from high-risk populations to volunteer, when, actually, most of our phase-one trials involve healthy people.
There's also the concern that the vaccine is dangerous or that a person could become infected with HIV by participating in a trial. That couldn't be further from the truth. These vaccines have been shown to be among the safest vaccines ever tested. This safety record is largely due to the fact that the vaccine doesn't contain live strains or weakened-or even killed-strains of the virus. The HIV-like components of the vaccine are made in the laboratory to ensure they cannot operate like a functioning virus.
How many people locally participate in trials?
We generally are testing several vaccines at a given time, and in a typical year, we might have about 100 volunteers. But more are always needed as we continue to build on the knowledge we gain from earlier studies. In fact, finding participants is an ongoing challenge. Partially it's an education issue. We have to overcome the misperceptions about what we do and show people that by participating they are doing something positive to advance medical science.
At our partner site in Soweto, South Africa, they call their volunteers "vaccine heroes." We want our volunteers to think of themselves in the same way. In fact, as history has shown, clinical trials are the only way medical science can bring the advances in fighting disease that we all have come to expect. Much like 50 years ago when people stood in line to volunteer for polio vaccine studies, we need that same kind of willingness today to combat this global epidemic.
What is the experience like for a typical volunteer?
Trials usually last from 12 to 18 months, and on average most participants will need to make a monthly visit that might last for an hour or less. The experience is a lot like giving blood, with the addition of a vaccine shot and perhaps several boosters.
National HIV Vaccine Awareness Day is May 18. How is this annual event honored locally?
There are several local events this month designed to raise awareness about vaccine research and recognize the contributions of our current and past volunteers. This year they include a health fair offered in conjunction with an appearance by Magic Johnson on Thursday, May 12, at Aenon Baptist Church at 175 Genesee Street. Our group is one of 12 community-based organizations invited to share information. We are also cosponsoring a town hall meeting May 18 at Mood Makers Books in Village Gate Square on Goodman Street to discuss HIV vaccine related issues. The event coincides with an exhibition featuring images by Clive Gray, an HIV researcher and photographer working and living in South Africa. The exhibit continues May 15 to 29.
Also, at the Medical Center on Tuesday, May 17, there will be an Awareness Day luncheon and presentation of photos from Africa. The event is from 11:30 a.m. to 1 p.m. in room K201.
How can people learn more about volunteering?
Participants between the ages of 18 and 50 who are in good health can call 756-2329 (756-2DAY) or visit our new Web site at www.shakenandstirred.org for more details.
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