Miami Herald - Tuesday, February 25, 2003
Fred Tasker, ftasker@herald.com

After a three-year trial with 5,009 human volunteers in North America, Europe and Australia, the California research company VaxGen announced Monday that its vaccine did not reduce HIV infection in the study group as a whole, or among non-Latin whites or Latins. But it significantly reduced infection rates among blacks and Asians, although they represented a small percentage of the sample.

The study resonates particularly in South Florida, where the greatest number of new HIV cases are among blacks and where Miami, Fort Lauderdale and West Palm Beach are among the top 10 U.S. cities for new infections.

"We're disappointed that it didn't work better in all populations," said VaxGen CEO Lance Gordon. "But the results were quite striking in non-Caucasian groups. Blacks, Asians and other minorities showed a 67 percent rate of protection. Among just blacks there was 78 percent protection."

VaxGen vowed to seek approval from the federal Food and Drug Administration, the last hurdle before making the vaccine commercially available. It could not predict whether it could meet its goal of selling the drug by early 2005.

Reactions from the AIDS and medical communities were strongly mixed. "We have seen some light at the end of the tunnel," said Dr. Jos Esparza, a leading expert at the United Nations AIDS agency in Geneva. "For the first time humans, not just monkeys, have been protected by a vaccine. If these results are confirmed, it will be one of the major achievements in HIV research."

But Margaret Fischl, pioneering AIDS researcher at the University of Miami, expressed strong doubts.

"I think they've jumped the gun even bringing this to such a big trial," she said. "I don't think this is a very good vaccine. There are more promising vaccines than this."

She also criticized VaxGen for announcing results in such detail before they have been subjected to peer review and published in a major medical journal.

And the AIDS group Gay Men's Health Crisis criticized VaxGen for creating false hopes in Africa and Asia, where HIV rates are the highest in the world.

"With small numbers of African Americans and Asians in the trial . . . making any statements about efficacy in this subpopulation is grossly premature," spokesman Gregg Gonsalves said.

The study's 5,009 volunteers, who received three injections of either the vaccine or placebo, included 4,185 whites, 326 Hispanics, 314 blacks and 73 Asians.

The conflicting emotions reflect the importance of the struggle, with more than 40 million people infected with HIV worldwide and rates soaring among minority groups and in Africa.

HIGH INFECTION RATE

In Florida, blacks account for 56 percent of all reported HIV cases, yet they make up only 18 percent of the state's population, according to a December 2002 report by the Florida Department of Health.

Latins have lower overall HIV rates, the Centers for Disease Control and Prevention says, making up 17 percent of Florida's population but only 15 percent of its HIV cases. But the CDC said HIV is increasing twice as fast among Latins as among white non-Latins.

One striking finding was that black and Asian volunteers produced higher levels of antibodies against HIV than did white non-Latins or Latins after receiving the vaccine -- hinting that the reason might be genetic.

Phillip Berman, the company's head of research and the vaccine's inventor, defended the study, arguing that, while the numbers of blacks and Asians were small, scientific analysis concluded that they were statistically significant.

But he, too, cautioned against overstating the results: "It would be wrong to assume that this is a genetic racial difference until we analyze the data more closely."

He said VaxGen will do more analysis of its trial results before submitting the vaccine to the FDA for approval.

Gordon, VaxGen's CEO, said his company had hoped to submit its vaccine for FDA approval on a "fast-track" basis and to produce a commercial vaccine as soon as early 2005. He said manufacturing plants that can produce two million doses a year are under construction in South Korea.

"Whether this finding of a subgroup effect [among blacks] will alter that will depend on whether it means we need to do additional studies," Gordon said.

He said the study soon will be submitted for peer review and publication.

In Florida, VaxGen's trials were carried out in clinics in Jacksonville, Altamonte Springs, Tampa, Palm Beach and Coral Gables, where a clinic called Care Resource gave the vaccine or placebo to 80 volunteers over four years and sent blood samples to a central VaxGen lab, said executive director Rick Siclari.

VAXGEN'S WEAPON

VaxGen's vaccine, called Aidsvax, is made from a protein called gp120, the same protein that exists on the surface of the human immunodeficiency virus, modified so it cannot cause infection. It is intended to provoke the immune system to create antibodies that will fight off real HIV infection.

Some researchers, including Fischl, see other vaccines, notably those that fight HIV by spurring "killer T cells," as more promising.

"Given the history of this field, I wouldn't place my money on anything," said Dr. Tom Coates, director of the AIDS Research Institute at the University of California at San Francisco. "It's a really difficult virus to stop."

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