The University of Pennsylvania's HIV Prevention Research Division, also known as Philly Vax, is one of the 17 sites throughout the country where the study has been in progress for nearly two years. The current target for nationwide participants is 2,200 - at Philly Vax, that number is 118. None of the sites, however, have reached full capacity and are eagerly looking to accept new participants.
Ummm after 2 years only 118 people have volunteered. what does this say?
HIV Vaccine Trial Highlights 30 Years of Progress
On June 5, 1981 the medical community first announced the presence of a disease we now know as HIV/AIDS. Thirty years later, millions have died from the disease and many millions more live daily with the difficulties of treatment. Antiretrovirals have made AIDS manageable in many cases, greatly increasing quality of life and life expectancy of the infected. But limited access to these drugs, largely a result of cost, has helped fuel a reemergence of medical research aiming to develop an HIV vaccine. HVTN 505, one of the largest of these studies funded by the National Institutes of Health (NIH), is helping to fuel a sense of measured optimism in the fight against HIV.
The University of Pennsylvania's HIV Prevention Research Division, also known as Philly Vax, is one of the 17 sites throughout the country where the study has been in progress for nearly two years. The current target for nationwide participants is 2,200 - at Philly Vax, that number is 118. None of the sites, however, have reached full capacity and are eagerly looking to accept new participants.
Several years ago, I was browsing Facebook, and one of my friends posted a link to the PhillyVax site, which highlighted the general guidelines to participate. It stated plainly that you must be 18-50, HIV-negative, a male or male-to-female transgender person who is circumcised and who has sex with men
Realizing I met all of the guidelines, I quickly filled in my information in an online contact form and waited for a response. The next morning Debora Dunbar, the clinical director of Penn's HVTN 505 study, called me to ask a few pre-screening questions. By the end of the conversation, we scheduled the in-office pre-screening visit.
The Pre-Screening Visit
This visit, I learned, serves several purposes. The first is to go over the specifics of this study. I discovered that HVTN 505 utilizes a type of vaccine known as a T-cell-based vaccine, where another type of weakened virus, referred to as a viral vector, is injected with the DNA from HIV. The new vaccine cannot cause HIV, but when injected into the body, it can stimulate the body's immune system to produce antibodies that lead to the development of a vaccine that may either help limit HIV's ability to spread throughout the body or fully prevent it from spreading.
The second reason for the meeting was for a blood draw to determine if I had adenovirus-5 (ad-5) antibodies in my system, which is the particular viral vector used for HVTN 505. If positive for ad-5, an individual's immune system would not respond to the potential vaccine, and no new antibodies would be produced.
Ad-5 positivity is one of the major disqualifications for many, as nearly 50 percent of all men in Philadelphia are positive. This is why PhillyVax remains below its target allotment 24 months into the study.
Risks of Potential Participation
Finally, I learned the risks of potential participation. As with any vaccine trial, pain and tenderness at the injection site are to be expected. Other serious side effects can occur, but the study expanded from 1,300 to 2,200 participants because of its safety.
Beyond physical responses to the injection, the body may produce HIV-antibodies that could linger in the body and produce a false-positive result in any rapid blood or oral HIV test. The HVTN 505 is very conscious that this potential side effect may deter participation, so they offer free HIV testing, in any country in the world, for the duration of the study and as long as any false positive result is received as a result of the study.
All of this knowledge was part of a larger consent process, which spelled out the potential risks and effects of the study, required participants to sign several consent forms, and conducted an oral test with participants to ensure all information was properly presented. After I signed, I officially booked my next appointment for two weeks later when the blood results would be completed.
The Second Screening Appointment
Last Monday, I came in for the second screening appointment to determine overall health. After taking my temperature and blood pressure, Dana, one of the nurses for the HVTN 505 study, left, and I slipped down into the paper-thin blue hospital gown. What followed was a brief and painless exam by Deb Dunbar to ensure I was properly circumcised and otherwise healthy. After the examination, I hopped back into my clothes and quickly scheduled my next appointment for Wednesday. This is when I would receive my first official injection.
Wednesday came, and as I entered the exam room, 22 empty vials stood motionless on a tray. A slight nausea seemed to develop quickly, but others had told me it wasn't as bad as it seemed, so I remained calm.Dunbar took my vital signs and temperature before asking to lie back on the exam table. As she prepared the needle and vials, I asked her why so much blood was needed. "In order to establish a base line for detecting future antibodies," she told me. She explained: "The larger the amount of blood drawn, the easier it would be to detect future changes."
Effortlessly, she slid the needle into my arm, striking up conversation as she replaced tube after tube with my blood. The whole process was shorter and less painful than I would have anticipated. Finally sitting up, I saw the filled vials. In this moment it struck me that I was officially part of this study. I was No. 85. What I was doing could eventually lead to a vaccine preventing HIV.
I had to wait, yet again, for the vaccine or placebo to arrive. In order to prevent bias on both the part of the participant or clinician, neither I nor anyone in the PhillyVax office is made aware of what I am receiving. Instead, Dunbar entered my number into a system that sends an e-mail indicating vaccine or placebo to the nearby pharmacist. The pharmacist must then thaw the injection and deliver it directly to the exam room.
After ten minutes, the vaccine arrived in an inconspicuous cooler. Dunbar opened the cabinet to reveal the Biojector 2000, a futuristic-looking device that uses pressurized carbon dioxide to deliver the vaccine into the muscle without a needle. The benefit is that it can inject the vaccine into more of the muscle, which encourages contact with more of the body's cells, increasing the chance of an immune response.
She loaded in the vaccine cartridge, explaining that other participants' reactions to the Biojector were mixed. Some felt it was more painful than a traditional needle, while others felt the opposite was true. I lifted up my left sleeve, and Dunbar pressed the device against my skin. A countdown followed - 3, 2, 1 - as she pressed the trigger. Though there was little initial pain, soon after, the injection site was tender to the touch, and as I lifted my arm my entire muscle seemed to throb.
To ensure no severe adverse allergic reactions occurred, the study requires all participants to be observed for 30 minutes. Though Dunbar repeatedly stressed that the incident rate of serious side-effects is marginal, this precaution is one of the many that increases the overall safety of the study.
The Study's Participants
Two days later, I was back in the office to interview Dunbar. While the science behind the study is important, I began craving a sense of the social and political sphere in which HVTN 505 dwells. As I sat down in Dunbar's office, as in any other interaction I had with her, she was eager to answer questions.
The first thing that struck me was my deeply personal relationship with HIV/AIDS. I've been aware of the virus because of a family member who has it. I remember back to when I was younger, when he nearly died of pneumonia. I remember the moment when I waited for an HIV test and wondered what I would do if I would be positive. From these experiences, I've been driven to do something about HIV/AIDS.
Though I had my own motivations, I wondered if they would be the same for others. So I asked: "What would compel people to participate in a study that has no direct benefit while at the same time it offered potential risk?"
"They do it for extremely altruistic reasons," Dunbar said.
But what exactly is altruism? Dunbar went on to define this by saying that the participants likely "know someone who has died from HIV and want to help prevent that from happening again. They feel very connected to the gay community and know that HIV continues to be a problem within the community. And they want to make that go away."
In this response, like so many other interactions, her energy and dedication were ineluctable. I quickly wondered what her back story was and what were her reasons for her involvement with HVTN 505. For nearly 30 years, she had been in close contact with AIDS, before it was even named and effective treatments existed. She described a moment in June 1984, fresh out of a Catholic nursing school, that she had been assigned, by chance, to the AIDS floor at Yale University Hospital.
"In those days, there was no test for HIV," she explained. "HIV wasn't even a word. People came in with AIDS and they were dead a month later. We had no medications, so we tried to do the best we could without knowing how to treat them. We didn't even known how the disease was transmitted, so I was putting on goggles, a mask, gowns, and gloves - everything - to go into the patients' rooms."
This experience changed Dunbar forever and has led her to HIV/AIDS research being what she calls, "her life's work." This became most apparent when the conversation over AIDS research turned political. Dunbar explained that a cure for HIV was far off, but in the meantime, "super treatments" were serving to make HIV/AIDS something other than a death sentence.
Evaluating Prevention Methods
Still, I wondered how technologies like pre-exposure prophylaxsis (PrEP), post-exposure prophylaxsis (PeP), or other antiretrovirals could be considered effective treatments when they cost around 10,000 dollars a year per patient.
"This isn't so much an HIV problem as it is a universal problem," Dunbar said. "We have a terrible health care system and the way to truly make these drugs available to everyone is to start treating healthcare like it is a right. How would you solve that? By finally putting through a single-payer healthcare system."
At the same time, she also recognized the difficulty in passing such legislation, especially as she looked globally. "In Africa, for instance, HIV treatments are rationed. Some people get treated and some people don't. But how can you define who gets treatment, who needs it the most? How is this life more important than that life?"
What else, then, could be done to help limit the spread of the disease?
Dunbar continued to affirm her position in prevention research, saying that, "no large scale effort to prevent HIV can occur without a vaccine." Basic actions like organizations giving out condoms and offering education on disease transmission will help lessen the spread of HIV. But the biggest action Dunbar offered extends well beyond the confines of HIV itself.
"We must recognize that sex is not rational." This recognition, she went on to explain, removes moralizing beliefs from the discussion on sex, helping to reduce stigma surrounding sexual practices and create a more sex-positive culture.
30 years later it is more imperative than ever that every individual take a stance in the prevention and management of HIV. Rates of HIV are once again rising, particularly among 18-25 year old men who have sex with men. Though prevention science is making advances, technologies and social acceptance have not caught up to the large numbers of people who are infected with HIV. My own contribution is being part of HVTN 505, but as Dunbar and PhillyVax have made clear, there are so many other ways to become active in treatment and prevention.
For more information on a testing site near you, please check out the list at Hope Takes Action. PhillyVax also has a Facebook page and Twitter account.
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