"Be a superhero and fight HIV! You can help us find a vaccine now!" proclaims silver-haired Storm, aka Jennifer Sarche, a community educator for the San Francisco Department of Public Health's HIV research section. She and her costumed colleagues have taken to the street to recruit volunteers for a study of the most promising HIV vaccine yet. Researchers are quietly excited by the product, developed by the pharmaceutical giant Merck, as it has already shown excellent results in lab and animal studies. The next step is to give the vaccine to individuals who are at risk for infection, and see if it protects them. In San Francisco, that means researchers need nonmonogamous men who have wild nights out. If they participate in the study, they'll be clubbing for a cause and having sex for science.
The pitch appeals to the purest altruistic thoughts, as volunteers get only a small stipend to cover transit costs and expenses. The participants are essentially putting their bodies on the line for the benefit of all: Even in San Francisco, where safe-sex education is ubiquitous, 10 to 15 people are still infected by HIV each week. The ads for the vaccine study that decorate buses and billboards invite men to imagine a day when they can "love without fear of infection," and ask them to help make it happen. "We don't know if this vaccine will protect anybody, and half the volunteers will be getting the placebo," Sarche says. "The people who are volunteering really are heroes."
At first glance the so-called "Step Study" seems morally questionable, as researchers will get results only if the volunteers engage in unprotected sex and put themselves at risk for infection. But Sarche explains that the Department of Public Health actively discourages volunteers from taking risks. "We ask people to decrease their risky behavior in these studies," she says. "We do risk-reduction counseling, give them condoms and lube, anything we can do. But we know, unfortunately, that counseling and condoms are not enough, and that's why we still need a vaccine." Researchers say that in past vaccine trials, participants have usually been more careful after receiving counseling. But the fact remains that 2 percent of the participants in the Step Study are expected to be infected during the four-year course of the trial.
Tai Trang is one of the 96 volunteers who has already stepped forward in San Francisco. "They were looking for high-risk people, and I guess I qualify," says the petite 42-year-old. He and his family emigrated from Vietnam in 1980, and he moved to San Francisco in 1991. He came out two years later, and admits that since then he has lived a somewhat decadent and dangerous version of the gay life. "Being a gay man in San Francisco, I have lots of sexual encounters with lots of different people, a lot of time with strangers," he says. "And sometimes, whether it's the influence of alcohol or the heat of the moment, you let your guard down and do things that you regret in the morning."
Trang says he has done volunteer work relating to AIDS for many years, and has done the 585-mile AIDS bicycle ride since 2000. When he began to see the posters around town asking for volunteers for the vaccine trial, it didn't seem like a big sacrifice. "I thought, somebody's got to do it. Why not me?" he says. He received the third and final shot a few weeks ago, and says he wonders all the time if he received the vaccine or the placebo. He can't help yearning for that extra feeling of safety like having an invisible suit of armor on but says he is motivated more by the potential benefit to the broader gay community. "I have a lot of friends living with AIDS, and you can see it, you can see people deteriorating. Even with the drug cocktail, you can see their faces change," he says. "I think the vaccine is the place to put money, because you're never going to completely stop people from taking risks. It's human nature."
Over the past decade, there have been previous bursts of hope for an HIV vaccine, and well-publicized failures. A vaccine developed by the South San Francisco company VaxGen made it all the way to a massive study involving more than 5,000 volunteers at the beginning of the millennium, and was widely touted as the best chance yet to stop the disease's spread. VaxGen's product relied on antibodies, the proteins used by the immune system to identify and neutralize free-floating viruses in the bloodstream. The hope was that the vaccine would use pieces of the HIV virus to train antibodies to recognize and mount an attack against the virus, should it enter the body. But in 2003, the disappointing results were announced: The vaccine had failed to prevent infection.
The vaccine tested by the Step Study so named because it's seen as the next step forward on the long path to success takes a different approach. To make the vaccine, Merck's researchers replicated three individual genes from the HIV virus. Everyone involved with the study emphasizes repeatedly that the vaccine is not made of a weakened or killed form of the virus, which means there is no chance that a volunteer can be infected with HIV by the vaccine. The three HIV genes used could not recombine to form an intact virus, and could not replicate to spread through the body.
The genetically engineered HIV genes are inserted in a disabled form of the common cold virus, which delivers them to cells in the human body. Those cells then manifest signs that they contain foreign proteins, triggering a response in the body's "Killer T" cells, the white blood cells that patrol the body looking for infections and attacking infected cells. Researchers hypothesize that the Merck vaccine will train Killer T cells to recognize HIV-infected cells so that if a real infection occurs, the body can mount an immediate shock-and-awe attack. "This is a completely new approach," says Jonathan Fuchs, director of vaccine trials at the city's Department of Public Health. "We're very excited about this particular product."
A small preliminary trial showed very promising results. Volunteers were given the vaccine, and 75 percent of participants had what the doctors call a "robust immune response"; blood tests revealed that those participants' Killer T cells recognized and responded to the HIV virus. That rate of success is on par with the rate of immune response in tests of the smallpox vaccine (one of the great success stories of modern medicine). Now, in this "proof of concept" study, researchers will learn whether that robust immune response will be enough to protect men like Trang from acquiring the virus.
There's one other possibility that the Step Study will test if the vaccine doesn't prevent infection, it might still teach the body how to fight the virus, and slow its spread through the body's cells. That raises the possibility that infected people might delay the need for antiviral drugs, and that they might live better, longer lives, as the body fights back naturally against the virus. Researchers hope to have the first answers to these questions in late 2007 or early 2008.
San Francisco is just one of 25 sites that are testing the Merck vaccine; other trials are ongoing throughout North and South America, the Caribbean, and Australia. Researchers hope to enroll a total of 3,000 volunteers around the globe, with other sites using heterosexual men or women as study subjects. San Francisco, with its complement of gay male test subjects, is leading the pack in recruitment with almost 100 volunteers so far, and public health officials are hoping to recruit another 50 before the end of the year.
The team advertises everywhere from the Bay Area Reporter to Craigslist. But Eduardo Lucio Villalon, another volunteer, has proven to be one of the most valuable advocates for the vaccine research team. Lucio Villalon and his partner have a nonmonogamous relationship, but he says they're both very careful. "We don't take risks, we don't take drugs," he says. The virus could get to them only if there's an accident, and a condom breaks.
The odds are good that Lucio Villalon's diligent precautions will protect him, and he won't be infected regardless of whether or not he has received the vaccine. But he's helping the study in another way, by serving as a very informal recruiter. First, he convinced his partner to sign up. Now, he promotes the study when he goes out on Saturday nights. "I try to tell my sex partners about it beforehand. I say, just so you know, I'm participating in this HIV vaccine study, and if you're HIV-negative, you should think about enrolling, too." So far, two casual sex partners have joined in.
"Whether it's going to be the vaccine or not, we will be participants in the effort to find a vaccine for HIV," Lucio Villalon says. Like other volunteers, he's proud to do his part, and hopes to bring the story of AIDS to a full circle: The epidemic exploded in San Francisco's bathhouses 25 years ago, and the greatest hope to end its spread might be discovered by the fellows dancing the night away at the End Up.