Chicago Tribune - February 25, 2003
Jeremy Manier, Tribune staff reporter

Numerous AIDS researchers said Monday there were too few minorities in the 5,400-person study to draw any conclusions about the vaccine's effectiveness in those groups. The vaccine's developer, VaxGen, agreed that the product had no effect whatever in the 90 percent of participants who were white or Hispanic.

"Overall what we see is the trial failed," VaxGen President Don Francis said Monday of his company's AIDSVAX vaccine.

The dispute over whether the vaccine might protect blacks and Asians caps a vaccine trial that many AIDS experts viewed as flawed and unlikely to yield a positive result. While Francis and other vaccine supporters hailed the effort as the first concerted attempt to develop an AIDS vaccine, other researchers said the company pushed the product to advanced trials with little evidence it would work.

Positive spin

VaxGen focused Monday on the results in black and Asian vaccine recipients, who had slightly lower HIV infection rates than subjects who received a placebo. The most pronounced results were in the black subgroup, where four vaccinated people were infected, compared with nine in the group that received no vaccine.

But Dr. Steven Wolinsky, chief of infectious diseases at Northwestern University, said those numbers are too low to suggest blacks got protection.

"This is a statistical game," Wolinsky said.

"These numbers are very small and difficult to interpret."

Other independent experts called the results in minorities "intriguing" and said VaxGen's approach merits further study.

"It still falls short of what I would call conclusive evidence that this will work," said Dr. Donald Burke, director of the Center for Immunization Research at Johns Hopkins University. "But there's enough of interest that it deserves serious additional attention."

Because the trial was limited to North America and Europe, experts said it had little relevance for HIV strains found in Africa or Asia, where the virus is most prevalent and spreading quickly.

One cause for doubts among some researchers was a recent federal investigation of a VaxGen executive on a conflict of interest involving AIDSVAX, which spurred concerns the company had taken its vaccine farther than evidence warranted. In 2000 the Tribune reported that VaxGen Vice President William Heyward had helped approve federal funding for AIDSVAX trial centers just before joining the company, while he was head of the AIDS vaccine unit at the federal Centers for Disease Control and Prevention.

Conflict of interest

The U.S. attorney's office in Atlanta ruled last year that Heyward was negotiating for work with VaxGen even as he used his position at the CDC to help approve funds for the vaccine trial. Heyward agreed to a settlement in which he paid the government $32,500 and admitted he "had a financial interest" in the vaccine decision.

"This isn't about science; it's about corporate survival," said John Moore, an HIV researcher at the Weill Cornell Medical College in New York.

VaxGen stock fell by 47 percent on Monday's news to close at $6.86 per share.

In theory, AIDSVAX should protect patients by spurring production of antibodies that halt infection. The antibodies are supposed to plug up molecules that would normally attach the virus surface to a target cell. But a preliminary 1998 study by a team of virologists including Wolinsky found no sign that the vaccine produced the desired immune response. VaxGen set a low target for success, hoping that 30 percent effectiveness would be enough for approval by the U.S. Food and Drug Administration.

FDA approval

Although Monday's results showed no effect for the overall group of 5,400 subjects, VaxGen officials said they will look into the feasibility of getting the FDA to approve the vaccine for use by minorities only. The agency has never issued such a limited approval for one ethnic group.

"It's not likely the FDA is going to license this based on what we've seen so far," said Dr. Richard Novak, a professor of infectious diseases who led the trial at the University of Illinois at Chicago.

Novak and several other experts said one of the most surprising findings was VaxGen's preliminary claim that non-white people who escaped infection had more antibodies from the vaccine.

"If it pans out that antibody levels correlate with protection from infection, that is a huge finding," Novak said. VaxGen would not release the antibody data Monday, saying the analysis is ongoing.

Although some experts said the results in minorities warrant further study, Wolinsky said the numbers are too flimsy to offer hope.

"They're confusing doing something with doing the right thing," Wolinsky said.

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