By Erin Sherbert
By Howard Cole
By Erin Sherbert
By Erin Sherbert
By Leif Haven
By Erin Sherbert
By Chris Roberts
By Kate Conger
For Francis, entrepreneurship was the only logical step following his failure to coax funding from the government in 1994.
"We got into the conflict of, one, 'Will it work?' and the decision got turned over to a political committee that saw money being taken away from treatment research. The activist community represented HIV-infected people, and it wasn't going to go anywhere," Francis says. "We said, 'Is there enough interest in the financial community to try to go this alone?' We signed up with a brilliant entrepreneur in Seattle, went out and hit the road, begging people, and raised $27.5 million, and so we rented this space, and with the money we spend, 80-some percent goes to the clinics carrying out the trials, and we pay Genentech to make the vaccine that we design."
Of course, the situation is not that simple. With the crusades of Don Francis, things are never simple. The scientific cloud that formed over his vaccine in 1994 has since darkened, at least in the minds of many researchers.
A widely discussed report in the February 1998 issue of the Journal of Virology cast further doubt on whether VaxGen's vaccine actually protects against HIV. The study looked at 18 volunteers who participated in an early gp120 trial and were later infected with HIV, and found that the vaccine did not seem to reduce viral infection in the supposedly protected volunteers.
"Basically, the data that we had, and the data we published, were not encouraging with respect to efficacy," says Steven Wolinsky, a Northwestern University AIDS researcher who was the principal investigator for the group that conducted the journal study. "We just were not able to find any benefit from the vaccine that was given in the context of a Phase I or Phase II trial."
Northwestern University was asked to act as a test site for the VaxGen trials and declined, Wolinsky says. "We decided to see what other candidates for a vaccine became available," he says.
For Fauci, the director of the NIAID, the journal article served as proof that his decision in 1994 not to fund a gp120 study was based on scientific, rather than po-litical, grounds. The study "fortifies the decision I made 3 years ago," Fauci was quoted as saying in Science magazine. (Fauci didn't respond to an SF Weekly request for comment.)
Francis argues that the previous trials with gp120 vaccines, which researchers used as a point of departure for the Journal of Virology article, were safety trials, and weren't designed to test the actual efficacy in preventing HIV infection. The only true efficacy trial conducted so far has been in a group of chimpanzees, Francis says, and VaxGen's gp120 vaccine has a proven ability to protect chimpanzees against HIV, and to produce strong immune responses in humans.
"The fact that none of our chimps came down with an infection was a very good sign," Francis says. "What you have to do is take five chimps, and put millions of dollars on those results. Everyone who receives the vaccine has an antibody against it, and the antibody looks the same as the one that protected the chimpanzees."
Nobody could have predicted that it would take 20 years and millions of deaths worldwide before this moment would come. But it has arrived. A version of the vaccine gp120, the first attempt to prove an inoculation can wipe out AIDS, is being tested in the city that has been seen as the disease's ground zero.
But in San Francisco -- a city that musters tens of thousands for AIDS rides and walks, for gay pride parades, and for gay Halloween bashes -- this historic moment has gone largely unnoticed, despite a fairly aggressive gay-community advertising campaign. After two decades of successfully enlisting gay men to help wage battle against AIDS symptoms, by way of AIDS-treatment research and AIDS-remedy drug trials, San Francisco health care workers are having a harder-than-expected time recruiting volunteers to help fight against the epidemic itself.
According to Healthline magazine, this is true all over the country: A national study to test the effectiveness of the vaccine, dubbed AIDSVax, has been slowed by would-be volunteers' reluctance to participate. In Irvine, Orange County, and Cleveland, reports have come back to VaxGen that recruiters are meeting people who "don't want to hear about" the vaccine, according to a Cleveland AIDS counselor quoted in Healthline.
VaxGen's public relations department insists that enrollment is going well around the country, claiming that two-thirds of the needed volunteers have been signed up nationwide. But the company refuses to provide specific numbers.
"Those were my instructions," says VaxGen's Amy Shuba.
The dearth of volunteer vaccine subjects is especially troubling in San Francisco, a city presumably at the front lines of the battle to defeat AIDS. At a trials site run by UCSF -- which is co-administering San Francisco's portion of the study along with the city Department of Public Health -- workers have so far only been able to recruit 31 of their 75-volunteer target group.
"The community is not coming forward with great gusto," says James O. Kahn, associate director of San Francisco General Hospital's AIDS program. Kahn, a man careful with his words, blames his site's lack of ability to recruit volunteers on the traditional reluctance of San Franciscans to settle down. Volunteers have to return to his clinic for regular checkups for at least three years. "A lot of people have less-than-consistent living situations or financial situations, and we don't want them," Kahn says.