The Bay Area Reporter - February 27, 1996
William Snow, ACT UP/Golden Gate Writers Pool

Two weeks ago, Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID), made national news by presenting his institute's strategic plan for HIV vaccine research and development. A major thrust of this plan is to formulate joint development plans with vaccine companies that give specific milestones to advance each vaccine approach into larger clinical trials. This would avoid the last-minute decision-making that derailed the gp120 trials in 1994, and provide manufacturers of candidate vaccines with criteria in advance to be met. Dr. Dino Dina of Chiron-Biocene stated at the same meeting that the industry cannot tolerate "a moving target." Both Drs. Fauci and Dina emphasized that a public and private partnership would be essential to share the risks and expenses of developing an AIDS vaccine. Of course, Dr. Fauci's speech also stated NIAID's commitment to strengthening collaborations with other private and public organizations, such as community and activist groups, foundations, and international bodies.

As an example, Dr. Fauci showed the joint development plan with Pasteur-Merieux-Connaught and Biocene, which is moving rapidly from Phase 1 to Phase 2 safety and immunogenicity testing. This is a "prime-plus-boost" approach where uninfected people are immunized first with a vaccine to prime one part of the immune system, then boosted later with a second vaccine that stimulates the other major source of immunity. The "priming" is done with the Pasteur-Merieux vaccine based on a canarypox virus, which is harmless to humans, that has been genetically engineered to express several HIV proteins. This vaccine has been shown to stimulate some cellular recognition of HIV. Injections of the priming vaccine are followed by one or more booster of HIV envelope vaccine, Chiron-Biocene gp120, which induces antibodies. The idea is to stimulate these two arms of the immune system, which should be desirable for protection from an infection that may need to control infected cells and free virus.

So it looks as if the canarypox approach is being moved onto the fast track toward Phase 2 trials in several hundred low and higher-risk individuals, with an eye toward possible large efficacy trials with several thousand at-risk individuals in 1998, much sooner that people had been expecting.

This prospect means that it is high time for communities like ours, where trials are likely to occur, to begin discussion of the scientific, social, ethical, and political considerations of HIV vaccine trials.

In 1994, at about the same time gp120 was put on hold domestically, a working group convened by the AIDS Action Foundation, under the leadership of Derek Hodel, now at GMHC, developed a very important document about these very issues. (HIV Preventive Vaccines: Social, Ethical, and Political Considerations for Domestic Efficacy Trials. Report of a Working Group Convened by the AIDS Action Foundation, July 1994.)

The working group was a model of collaboration and cooperation among a broad range of community representatives, scientists, ethicists, and government, in the belief that the development of a vaccine against HIV demands unprecedented collaboration. Their stated intention was to help shape federal policies and foster informed conversation among the public at large and in the local communities that will be targeted for these trials.

The report begins with an important statement of principle:

"An ethical HIV vaccine efficacy trial requires a partnership among individual participants, their communities, investigators, and trial sponsors. Mutual obligations flow from this partnership, born of a common goal of ending the HIV epidemic.

"At the outset, an ethical clinical trial must reasonably be expected to answer the questions posed. Thus, an ethical vaccine efficacy trial must be designed to be the most efficient and humane means of addressing scientific uncertainty, to demonstrate whether the candidate vaccine is safe and effective.

"Conducting an ethical vaccine efficacy trial must be the result of having favorably weighed the potential for scientific knowledge (against the consequences of not acquiring such information) and the financial, social, and human costs associated with conducting (or not conducting) such a trial.

"Just as deployment of a successful vaccine will complement other HIV prevention and treatment strategies, vaccine research must complement other HIV prevention and treatment research. Vaccine trials must be designed to enhance, not to impede or diminish, other HIV prevention programs.

"An HIV vaccine efficacy trial is a public health effort requiring coordination and support beyond the domain of any single agency or institute; it must involve local and federal public health agencies and private partners, including industry."

HIV vaccine efficacy trials should begin only when there is sufficient scientific justification to proceed and when community feasibility has been demonstrated. The decision to commence HIV vaccine efficacy trials must be the product of a partnership involving scientists, government officials, research sponsors, and members of communities at risk. t

ACTion UPdate

How To Get Involved Now

Preliminary research, critical to determine the feasibility of conducting vaccine efficacy trials in various populations at risk, is being done in San Francisco through the HIVNET vaccine preparedness studies at the San Francisco Health Department, and Project LinCS (Linking Communities and Scientists) at the UCSF Center for AIDS Prevention Studies (CAPS), which is an in-depth study of the San Francisco gay community.

You can get involved in this process early by joining the Community Advisory Board (CAB) of HIVNET, which meets once a month at the Health Department (call the CAB at 703-6438 or the Health Department Research Branch at 554-9030; ask for information about the HIVNET CAB), or the Community Advisory Board for Project LinCS (call Tom Slama at 597-9290).
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