The Bay Area Reporter - July 23, 1999
Bill Snow, ACT/UP Golden Gate Writers Pool

There are two parallel trials -- one mostly in the U.S., but also Canada and Europe -- of 5,000 men who have sex with men and 400 women at sexual risk. This trial has about 60 sites and has enrolled around two-thirds (over 3,000) of the volunteers needed. In San Francisco, enrollment continues at San Francisco General Hospital and the Department of Public Health. If you are interested in participating, see the ACTion UPdate below. The second trial is at 17 sites in Bangkok with a Thai version of AIDSVAX in 2,500 injection drug users. VaxGen hopes to complete enrollment of the domestic trial this summer and of the Thai trial by sometime next year, with results three years from the end of enrollment, which means some time in 2002. A private interim analysis by their Data and Safety Monitoring Board will occur in the second half of 2001.

The VaxGen products are synthetic copies of proteins from the surface of HIV that are incapable of causing HIV infection, which have demonstrated good safety in earlier phase 1 and 2 trials. Their products are further along in development and differ significantly from those used in another trial that announced phase 2 clinical trial results last week (ALVAC canarypox prime, with SF-2 based gp120 boost).

The company

The other VaxGen news is that the company recently raised money for its research by a public offering of its stock, which raised in excess of $42 million for the company. The offering was well received, good news for VaxGen and for other vaccine developers; and its price has more than doubled with heavy trading since the initial offering. But, as a venture capitalist we know says, "Unfortunately not many HIV viruses follow the stock market, and so the probability of phase 3 success remains pretty much the same as it was a few weeks ago."

The future

So what's next for VaxGen? First, they hope to complete enrollment as soon as possible to get the clock ticking toward results day. Then retention of the volunteers over the three years of the study will be critical for the validity of their results. Lately, the Centers for Disease Control and Prevention announced that it will provide additional funding to some of the U.S. VaxGen sites to study social, behavioral, and epidemiological aspects of this groundbreaking trial. This is to learn as much as we can about conducting future vaccine efficacy trials, which will no doubt be necessary

VaxGen is also proposing that the government fund development of another version of their vaccine designed specifically for Africa, which may be safety tested in San Francisco. Having volunteers here test the safety of a vaccine for the hardest hit part of the developing world (sub-Saharan Africa) would demonstrate our commitment toward international cooperation between Northern and Southern Hemisphere countries in developing HIV vaccines for all.

Community

In light of these activities, the AIDS Vaccine Advocacy Coalition (AVAC) just issued this statement calling for individual and community participation in the HIV vaccine research and development effort. (The editorial additions in parenthesis are my clarifications.)

"Recent media coverage of the government's AIDS vaccine effort has highlighted the AIDS Vaccine Advocacy Coalition (AVAC's) reservations about the speed, coordination, and extent of those efforts. AVAC urged the government to be bolder in coordinating its agencies' agendas, and to establish clear interim goals that can be tracked for progress. Now AVAC issues a similar call to the general public and specifically to the HIV community asking for greater community participation in all aspects of AIDS vaccine research and development.

"This call encompasses becoming informed about HIV vaccine research, joining trials if eligible and willing, participating in Community Advisory Boards, working with AIDS prevention and treatment groups to incorporate vaccine awareness, and donating time or money to AIDS Vaccine groups or AIDS groups that contribute to vaccine research.

"AVAC wishes to emphasize here that it is impossible to develop and approve an HIV vaccine without Phase 3 clinical efficacy trials in at-risk populations, so we strongly support clinical testing of vaccine candidates. Phase 1 and 2 trials for safety and immune response, often in lower risk volunteers, are necessary prerequisites to discovery of a safe and effective vaccine, as is continued community monitoring of research and clinical programs. AVAC supports more active community participation that includes joining open trials and joining the community advisory boards (CABs) that monitor such trials. CABs in particular must be broadly based and strong in order to ensure substantive community input regarding the conduct of trials.

"Currently, VaxGen is the only company to have put a candidate AIDS vaccine into a Phase 3 trial, and it is notable they have accomplished this (largely) through private investment. AVAC considers the efforts of companies like VaxGen to be crucial to the development of an AIDS vaccine, and believes that in addition to government research and development private industry must become much more involved in the research and development effort. Clearly, AVAC's call for increased community participation is immediately relevant to the testing of VaxGen's AIDSVAX among thousands of volunteers for effectiveness as an AIDS vaccine.

"Throughout the history of AIDS activism one of the key principles has been that community based groups like AVAC have not used their credibility with the people who are qualified to participate in trials to recommend that they put their bodies on the line to participate in trials of experimental agents. These must be individual decisions, guided by as much open information, consultation, and discussion as possible. This is especially true when dealing with vaccines for healthy people who are at risk for acquiring HIV infection (outside the clinical trial).

"Trial participation involves a level of commitment and uncertainty that will not be right for everyone. Each individual must carefully consider the risks and benefits of volunteering before making his or her own informed decision to participate. In addition, the conduct of fruitful and ethical research must always be safeguarded by the involvement of informed community members at all levels and stages of the research process. For those who are willing to accept some risk, volunteering for trials is an altruistic and courageous act of support. Dr. Peter Piot, the director of UNAIDS, has called trial volunteers 'the anonymous heroes of AIDS vaccine research.'

"Regardless of any individual's decision to participate in a trial, and regardless of the product being tested, increased awareness and participation among the communities affected will always be necessary. Community based organizations and prevention planning groups should hold discussions on the impact of vaccine research on local educational efforts." (AVAC, July 16, 1999.)

ACTion UPdate:

The VaxGen website not surprisingly is http://www.VaxGen.com. Inquiries and enrollment locally are through the Department of Public Health and San Francisco General at (415) 514-4822, and toll free at (877) 682-9436 for other locations. For information on the VaxGen National Community Advisory Board contact Tom Porter at VaxGen, (650) 624-1034. For the full AIDS Vaccine Advocacy Coalition statement and information about other open trials, vaccine sites, CABs, and vaccine advocacy organizations, you can e-mail Scott@avac.org or check http://www.avac.org.
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