Pushy guinea pigs

You’ve seen the posters around Church and Wellesley: Volunteers needed for an important vaccine research trial.

Actually, researchers don’t want just anybody – “sexually active gay men” are required, because of their relatively high risk of contracting HIV.

VaxGen of San Franscisco is conducting the first HIV vaccine trial to make it all the way to a Phase 3 clinical trial (which means a randomized test on humans, where some get the shot and some get a placebo).

And the trial raises all kinds of important issues for gay men. Issues like the experiment’s dependence on some participants getting infected with HIV. And like the false expectations that can be created by the word “vaccine” when it’s uncertain how effective the shot will be.

To join the VaxGen trial, participants must sign a 13-page informed consent form and agree to regular safer sex counselling. According to the principal investigator in Toronto Dr Ken Logue, even if HIV-negative gay men adhere to safer sex guidelines, they run an estimated 1.5 percent risk each year of becoming infected for reasons such as condom failure.

“So if the vaccine is, for example, 50 percent effective, that risk would go down to .75 percent,” he explains.

Toronto is one of 61 sites for this first-of-its-kind trial. Vaccine development for any disease is a slow process, taking on average 10 to 12 years. But for many political, economic and scientific reasons, HIV vaccine development has been even slower than usual.

In 1997, the late Jonathan Mann, former head of the World Health Organizations’ Global Program On AIDS, observed: “Very simply, if 40,000 college students were becoming HIV infected each year, it’s obvious that field trials of AIDS vaccine candidates would have been long underway.”

Lately, efforts have picked up. “The United States has revved up vaccine research in the past couple of years because there is finally some recognition that AIDS has the potential to destabilize whole parts of the world,” says Dr Kelly McDonald, a Toronto-based infectious diseases specialist and vaccine researcher.

McDonald was among those who pushed for Canadian sites to be included in the VaxGen trial. She doesn’t think the VaxGen effort is perfect, and certainly controversy rages in scientific circles about just how effective (or ineffective) it will prove to be.

“But,” says McDonald, “I’m excited because it will give us experience about how best to run these clinical trials.”

Meanwhile, the company and researchers stand to learn a great deal even if, as many predict, VaxGen won’t be highly effective in preventing infection.

But what do gay men have to gain and to learn from this trial and the prospect of others down the road?

Gay men were picked for the VaxGen trial mainly because they are at high risk and outreach is relatively easy. The gay community should use this leverage – its desirability as a testing pool, and the fact that the supply of volunteers is limited – to insist on certain conditions for participation, says David Thompson. He’s been examining the legal and ethical issues about vaccine trials for the Canadian HIV/AIDS legal network.

Further, he says the community should organize on a national level, so cities are not played off against each other by research companies and academics.

What kinds of conditions might be desirable?

Vaccine testing must be broader than the gay community. Other people at high risk – injection drug users, Aboriginals, prisoners, women – must be part of the process.

“Work on vaccines should reinforce community development in other populations. Gay men should insist that others are included in trials as a condition of themselves participating,” Thompson says.

The gay community, in consultation with interested groups, should spell out its own requirements for informed consent instead of accepting forms developed by research companies and ethical review boards, Thompson says. In Montreal, a community advisory board produced revisions to the standard VaxGen document, he said. But because of time constraints, this was done after initial forms were signed. The gay community should discuss these issues now, instead of dealing with situations on an ad hoc basis, he says.

There should be a feedback loop into the community from the trials. For example, VaxGen researchers should evaluate the effectiveness of the safer sex counselling they offered, and share findings with the gay community.

The gay community, and other affected communities, should be educated about and prepared for clinical trials of vaccines. For example, many people associate vaccines with the shots they got as children and expect 100 percent protection. But most vaccines are only partially effective. In the case of an HIV vaccine, success – at least in the short term – may well be an injection that doesn’t prevent infection but does ensure a lower viral load.

“We have to re-educate people from the ground up. That costs money and I think industry and government has to pay for it,” Thompson says.

Finally, Thompson says would-be trial participants need an impartial, independent source of advice about what he calls “the best predictive possibility of success” of a given vaccine. People need more information than they’re going to get from companies or researchers.