(The Root) — First do no harm. That’s the golden rule of medicine. But a new analysis of a trio of AIDS-vaccine trials shows that’s exactly what happened in two of the three studies.
In trials conducted across four continents with a combined total of more than 6,000 participants, vaccines using a flulike virus that were designed to protect men and women from contracting HIV actually made it 33 percent more likely that those men and women would get infected. The analysis was presented on Thursday at AIDS Vaccine 2013, an international conference in Barcelona, Spain. Though this data isn’t brand-new — and, in fact, each of these studies was stopped once scientists realized that the vaccines didn’t work — this was the first public glimpse of the unpublished data pooled from all three studies.
The news was particularly disappointing, since an AIDS vaccine would be a game changer. Worldwide, 2.3 million people become newly infected with the virus each year, and Africa continues to be the world’s most affected region. In the United States, blacks make up nearly half of all new HIV infections, and AIDS remains one of the top killers (pdf) of both black men and women.
Although new infections have dropped by one-third over the past decade because of improved prevention methods, even in the United States only 25 percent of people with HIV are receiving treatment to the point where the virus is “undetectable” in the bloodstream. This leaves them vulnerable to getting sick and spreading the disease to others.
There was some good news in the report: When teased out, one of those three trials — the one focused on the U.S. only — showed no increased risk to those who received the vaccine. The studies were looked at together because each used a form of adenovirus, a cousin of the common cold. If the U.S. trial is taken out of the mix, the elevated risk of infection in the other two studies combined soars to 41 percent.
The U.S. trial targeted gay men and transgender women, and only 16 percent of participants were African American. It is still difficult to recruit blacks — LGBT or straight — into any kind of medical research. Well-documented distrust of the health care system and a false belief that the government infected communities of color with HIV kept African Americans from mobilizing early in the AIDS epidemic. And it keeps many of us from taking part in AIDS-vaccine trials.
“It’s better than in the past, since so many of us now know someone with HIV and want to help,” says Steve Wakefield, director of community education for the HIV Trials Network. “There’s also a sense that people who participate in research are now heroes, whereas in the past they were seen as crazy. But it remains a challenge.”
Today’s announcement added a wrinkle to the quest to find a vaccine that stops HIV — a frustrating 30-year journey characterized by one step forward, two steps back. Those involved in the studies took pains to look for the silver lining. “There is no such thing as a failed trial,” said Dr. Glenda Gray, the chair of the research conducted in South Africa. She struggled to control her emotions as she discussed the results of her study at the press event today.
“These trials tell us very important things, and the findings help us move forward,” she added. “That said, every participant, whether on the placebo or the vaccine, is precious to us.”
Researchers stress that AIDS vaccines — including the ones analyzed in the new report — do not cause infection, a common misconception. Vaccine trials work this way: Scientists recruit participants to a trial and divide them into two groups. One set of people receives an experimental injection that may protect against HIV, while another group is given a placebo, or “mock,” vaccine.
Researchers then compare the two groups over time. Everyone in the trial receives a standard package of prevention — including safe-sex counseling, condoms and treatment for other sexually transmitted infections — to minimize the risk of contracting HIV.