AIDS RESEARCH AND HUMAN RETROVIRUSES Volume 8, Number 8, 1992 Mary Ann Liebert, Inc., Publishers

International Conference on Advances in AIDS Vaccine Development

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Bill Snow. For the last few years, I've followed and reported on vaccine research and development for ACT UP New York's Treatment & Data committee. Last year, after we convinced the AIDS Clinical Trials Group to open its meetings, someone here realized we were useful, or that it was politic to include us, and we were invited to attend this conference. This year we've been asked to talk to you about


name is

"constituency" priorities. "Constituency" is the safe government name for AIDS activists, patient advocates, community service groups, and people with HIV themselves, though we don't elect you or chose you to make decisions for us. As scientists or business people, and only amateur politicians, you may not have thought about having a constituency before. You probably don't think of yourselves as representing us except in the most general, vague ways. Many of you work in laboratories with specimens or animals and never interact with us. Even those of you involved in clinical trials work with seronegative or asymptomatic, healthy patients. Our advice about you constituency is this. Everyone needs a vaccine for AIDS, but "everyone" isn't a constituency. It is people known to be at high risk, those with the same demographics as the disease who will benefit most immediately and most directly from your vaccine—if they will take it, and if they can get it. Let me remind you who they are: gay men, IV drug users and their sexual partners. Blacks and Hispanics, certain unborn infants, prisoners, bisexual men and their sexual partners, whole populations in Africa. Let me tell you who they also are: adolescents, prostitutes and their clients, sexually active heterosexuals, whole populations in Asia. And they are also your colleagues: medical personnel who care for AIDS patients and laboratory workers. As activists, we have consistently pressed for participation in decision making and access from all affected groups, no matter how uncomfortable that may be. In ACTG, representation has taken the following forms: •

Open meetings A Community Constituency Group ACTG committees

whose members vote


Community Advisory

Boards at each ACTG trial site

Through our insistence and hard work, government, scientists, and the AIDS communities are getting to know each other well enough so that valuable informal communication channels have also developed to exchange information and opinions. These mechanisms haven't been in place long enough to prove themselves effective. Activists are divided on whether or not to support them. Some see them as cooptation, others as an opportunity to make changes from within. Certainly they've changed the tone and flavor of ACTG work, and introduced a realistic, patient-oriented point of view as well as a certain amount of healthy discomfort and open disagreement. I believe that many potential problems can be identified earlier and addressed through these mechanisms, and that we all benefit from open discussion and the urgency of our viewpoint. Yet, I don't believe these mechanisms will remove the need for ACT UP's kind of activism. It is essential for you to move now and make the same provisions for community participation in the vaccine development effort: 1. Leaders of the Vaccine Research and Development Branch should set up a community advisory group that participates in

decision-making as soon as possible

2. All AIDS Vaccine Evaluation Units should have active

community advisory boards publicize your meetings in affected commu-

3. Use outreach to nities

Focus on populations with a high incidence of infection. We educated and experienced from our drug development battles and are learning the specifics of vaccine development very quickly. We are also the ones who will be essential for vaccine efficacy trials. Wherever public funds are being spent or human experimentation is taking place, you have an ethical obligation to let us in. It's not news that we live in a country where we can't educate freely about safe sex, or give out condoms or clean needles without a fight. There is no reason to believe you'll be able to give your vaccine freely either, if those in political power think are

Representing ACT UP New York. 1433




1 recognize that I took a personal risk, but I've also started asking myself if the investigators know what they're looking for


projected. Are they only looking fishing expedition?

it will promote promiscuous sex, homosexuality, freer drug use, teenage sexuality. We have experience, a perspective, and a kind of moral authority that ultimately could help the vaccine development effort succeed, provided we can really work Last year we heard three priorities from the National ative Vaccine Development Groups:

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One: Given the urgency research is "irrelevant"

of the epidemic,



Yet, we've heard all week that knowledge of immunity is far from complete. From the patient standpoint, a most obvious and urgent need is for the animal researchers who have demonstrated some immunity to characterize the immunological effect on every part of the immune system. These results could then be used as a basis to determine efficacy and trial endpoints that don't depend solely on T4 cells or clinical events that seldom occur in the patients with healthy immune systems you've been choosing for trials. Especially with so many potential agents, this will reduce the need for too many and too large efficacy trials. Two: Highest priority will be evaluation of vaccines



large-scale SIV

A key idea should be to coordinate early animal and human experimentation. Instead, developers fall into one camp or the other, often due to their interpretation of the logistics and economics of drug development. Animal and human experimenters must work together with greater synchrony. Ideally, animal experiments would provide guidelines and data for similar human experiments, perhaps conducted nearly in parallel. In animal trials you would look for immunology that could be used to determine progress in human trials, and you could do

challenge experiments, and compare in vitro results. Three: Empirical research is not the best strategy, but conduct as many phase 1/2 trials as possible, as soon as


logical approach? Are these trials asking and answering key questions? Are they as safe, as important, and as good for subjects as possible? The AVEUs must run their own seropositive trials too. I'm a patient in the only ACTG vaccine trial. It has 52 patients, and it took almost a year for the protocol to be revised and drug made available. I almost wasn't included because my T cells declined during the delay; I have two friends who weren't. It took 7 more months to complete enrollment. Now, after 10 months and 5 shots of vaccine or placebo, nobody seems to know precisely what they've got. In vitro, my blood proliferates to gplóO and gp!20; it didn't before. There have been no dramatic changes in T cells. I'm still feeling fearful Is this

but fine.


in these human trials? No clinical outcomes have ever been for in vitro results? Is it a

Prohibition of concurrent treatment is a problem we've fought in most drug trials. It will also arise in vaccine trials for seropositives. It is unrealistic and unfair to exclude standard of care treatments even if it will keep your data clean. When efficacy trials begin, we will demand expanded access for those who can't get into them, lacking other treatment options. In our minds, doing nothing until you get sick enough is not another treatment option. This is a "life-threatening" illness, no matter how many T cells you're lucky enough to have at the moment.

Here's what to keep in mind for human trials in seropositives: •

Perform trials in groups that represent all major routes of infection Treat seropositives as a valuable resource even though there are more of us than other experimental animals, and many are ready to take risks For informed consent, clarify endpoints from the patient point of view—it's hard not to grasp at straws when you're in our position, and researchers who are excited about their research and need subjects look like they're excited for you Concentrate on fairness; assure access to vaccines after the trials end; and most importantly, get community input

can also help with planning seronegative trials since we're knowledgeable about sites, enrollment, fairness, willingness of patients to participate, avoidance of risk behavior, and trial speed. There are many AIDS activists from high-risk groups who are seronegative themselves. Risk populations have strong reasons to participate if approached correctly and responsibly. Their participation also will give us all the most reliable and


relevant information. Vaccine research and development has been charmed. You make regular small strides. You report at the end of conferences to close them on an upbeat note. You get good press because the press and the public love the idea of a happy ending to end the AIDS crisis, ready to forget millions already infected. AIDS activists aren't breathing down your neck, yet. Still, you haven't had to produce anything but hopes, prospects, and the bits of science that are important to us all. There are no timelines yet, no commitments, not even particular vaccines or cocktails of vaccines decided upon, just projections that are, comfortably for you, uncomfortably for us, far away. A fraction of AIDS spending goes to you, but that could change in an instant. As you work toward academic-industrygovernment cooperation, as you plan and work together, you must include us. your "constituents."

International Conference on Advances in AIDS Vaccine Development.

AIDS RESEARCH AND HUMAN RETROVIRUSES Volume 8, Number 8, 1992 Mary Ann Liebert, Inc., Publishers International Conference on Advances in AIDS Vaccine...
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