AIDS vaccine to get large-scale human trial 7,500 healthy volunteers to take part in 3-year test


SOUTH SAN FRANCISCO, Calif. -- Scientists at a tiny biotechnology start-up company have engineered the first AIDS vaccine that looks promising enough to merit a large-scale human trial.

The VaxGen Inc. study, which will begin sometime this year, will involve 7,500 healthy volunteers, cost $20 million and take three years to complete. If it is successful, the vaccine would be available to the public in the early part of the next century.

The vaccine -- which AIDS activists say is a significant advance in the fight against the disease -- reintroduces a strategy that several years ago was widely thought to have failed. Its key ingredient is gp120, a protein that helps hold the AIDS virus together.

The mixed results of studies of an earlier version of the protein vaccine were initially not considered encouraging. Now, VaxGen researchers have come back with a similar vaccine that appears to be much more robust.

Donald Francis, VaxGen president and a veteran virologist who has helped eradicate smallpox and contain the Ebola virus, said preliminary studies are hopeful: All but a handful of the 1,000 people who were injected with an early form of the vaccine have shown a strong immune system response.

"There's nothing magic about this vaccine, but it's our best hope so far and it's time to take the next step," he said. "I am optimistic."

Like Francis, many AIDS researchers and activists say the development is a milestone -- but not a miracle. Because of the tremendous diversity of the virus, researchers increasingly agree that a single vaccine won't work on everyone. So even the success of the new vaccine would not mean the end of the epidemic that has haunted the world for almost 17 years, researchers say.

Even if the VaxGen study is not successful, however, researchers say the time and expense won't be wasted: The world would gain much-needed knowledge about how the virus operates.

Of the more than 40 other vaccine candidates developed by industry and academia, most performed disappointingly in small-scale human tests.

Only one other has looked promising enough to make it even to the second phase of clinical trials, which involve several hundred people and are designed to test the safety of a treatment.

The vaccine produced by VaxGen, a spinoff of biotechnology pioneer Genentech Inc., is the first to win U.S. Food and Drug Administration support to move to "phase III" testing designed to determine the effectiveness of the treatment.

Pub Date: 1/12/98

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