New HIV/AIDS vaccine study seeks volunteers
Life was quite scary for Tom Kennedy at a time when many of his friends were dying from what was then an unidentified disease and he was coming to terms with his sexuality.
"The reality of HIV dictated a lot of my life between 17 and 35," Kennedy, now 43, said. "The fear of getting HIV was at times very overwhelming in the early days and there was this constant worry associated with sex and dating ... that it would kill me."
Fear eased its grip on Kennedy after the introduction of AIDS anti-retroviral medications. Despite the fact he did not live with the virus, this development made a lasting impact on his life. And so, four years ago, when the news of a clinical trial for a vaccine that may help end HIV/AIDS was the buzz among service providers and gay men, Kennedy made the decision to participate.
"There was renewed excitement about the possibility of finding an HIV vaccine and what that would mean," Kennedy, a social network strategist who lives in San Francisco, said. "I decided to become a volunteer because without volunteer we’ll never find an HIV vaccine."
The study, known as the Step Study, ended for Kennedy less than two weeks ago. He learned that he was one of several volunteers who received a placebo in the study, which make him eligible to participate in the 505 HIV Vaccine Study.
"When I think about the things that I am most proud of doing, being a vaccine volunteer is at the top of that list," he said.
The HIV Vaccine Trials Network investigators, who conducted the Step Study, found the vaccine used on other volunteers did not prevent HIV infection. Researchers found, however, valuable knowledge they have incorporated into the 505 study.
"All research is iterative, it leads to something else, incremental, you learn something, then you apply that to something, then you learn some more, -whether it is treatment or a potential cure down the line," Colleen Murphy, director of community education and outreach for AIDS Research Alliance in Los Angeles, said.
The ARA, which has conducted HIV/AIDS research for the past 20 years, is among the the organizations that have agreed to help conduct the study. Staffers spend a substantial amount of time speaking to LGBT and other groups about the importance of HIV/AIDS research and the research’s meticulous prevention efforts.
"One of the statistics that is most overwhelming is that while HIV treatments have been very successful, for every two people put on HIV treatment, there are five new infections, according to the Joint United Nations program on AIDS/HIV," Murphy said. "That just shows HIV is outpacing our ability to fight it."
The HVTN is recruiting 1,350 volunteers for the 505 study. Half of those participants will receive the investigational vaccines; the other 675 volunteers will receive a placebo injection. The study has an 18-month enrollment and participants may be observed for up to five years. A small stipend is awarded to the participants for their time and travel based on the clinic to which they go.
"They don’t know and we don’t know, so that we are not biased because we want to be as objective as possible," Beryl Koblin, head of the Laboratory of Infectious Disease Prevention at the New York Blood Center, also known as Project Achieve, which also is part of HVTN, said. "It is important to develop a safe and effective vaccine. Getting there is going to happen through a long process and we need to be taking what we’ve learned in the study to have an effective vaccine."
In addition to New York and Los Angeles, clinics in Atlanta, Bethesda, Md., Birmingham, Ala., Boston, Chicago, Nashville, Tenn., Philadelphia, Rochester, N.Y., San Francisco and Seattle are taking part in the study. Participants must be men who have sex with men, 18 to 45 years old, circumcised and HIV negative.
Koblin said she feels it was important for her agency to participate because the five boroughs have the highest number of people with HIV/AIDS in the country.
"For that reason, it is really critical for New York to be involved in this (research) and the collaborative," she said. "We still have a significant epidemic... We hope we can be advancing the science through (the study) and staying engaged in the community."
The study will examine two vaccines in its second phase. One will be used to prepare the immune system and another will boost its response.
"We are enrolling people who are HIV negative because the trial is testing how well the vaccine candidate keeps people who are negative, negative," HVTN spokeswoman Cheryl Stumbo said. "Like vaccines for other diseases, it’s about prevention, not cure."
The regimen consists of a series of three immunizations with a DNA-based priming vaccine within a two month period that is followed by a single shot at the sixth month that stimulates the immune system. The latter uses a disabled virus that would otherwise cause a cold; neither the DNA-based nor the disabled cold virus can infect a person with HIV. They are not made from live, killed or weakened specimens, but researchers want to know if the regimen can reduce viral load in people who later become infected with HIV and to provide additional information about its safety that may help scientist develop improved vaccines in the future.
"We have a learned response to slow down when we recognize a parked police car," Steve Wakefield, the Seattle-based associate director for community relations for HVTN, said. "Our goal is to try to teach the body to respond (similarly.)"
Study participants receive counseling, prevention education and condoms.
"The goal is to find a vaccine that prevents people from getting infected," Wakefield said. "What this study will do is teach us whether or not this approach will heighten the body’s ability to recognize the HIV upon subsequent exposure to the virus."
Researchers were quick to point out they are not encouraging participants to engage in unprotected sex. One of the study’s challenges, however, remains whether a vaccine may actually protect against HIV/AIDS. Wakefield warned it is not the "magic bullet." And he stressed why researchers provide continual counseling and education to participants about the dangers associated with unprotected sex and other HIV/AIDS risk factors.
"If someone says, ’I’m’ just going to have unprotected sex anyway, so I can take part in your research,’ then they are not a good candidate for the research," Wakefield said. "A person has to understand the risk benefit ratio of being in the study ... We can’t in good faith put them in the research study."
Wakefield added another challenge includes finding participants in the first place.
"HIV has such a strong stigma," he said. "If someone says I’m going to participate in HIV research, people think they are somebody living with HIV or at risk of contracting HIV."
Kennedy remains among those who sees what he describes as the benefits of becoming involved with such a project. He said getting tested regularly, which part of the study regimen, eased his concerns and reaffirmed his commitment to safer sex.
"For the first time in my life, I really , really know I was negative because I was tested so often and that made me want to protect myself even more," Kennedy said. "I believe this new trial will give even more information about how to build an effective vaccine. I want to continue to do my part to end the global epidemic of HIV."
Log onto www.hvtn.org for more information.