AIDS Vaccine Trials Not Yet Approved

VaxGen Inc., a small biotechnology company, has not yet received approval from the Food and Drug Administration to begin human trials of an AIDS vaccine later this year, the company said Monday.

The $20-million VaxGen study would involve 7,500 healthy volunteers and would take about three years to complete, company spokeswoman Donna Walters said. If successful, the vaccine could be available to the public early in the next century.

There had been newspaper reports that the FDA already had approved so-called Phase III clinical studies for the vaccine known as AIDSVAX. But Walters said the company is still seeking approval.

“These reports are premature,” the company said in a statement released Monday, adding that it is in the process of reporting the results of its first two testing phases to the FDA. VaxGen is a spinoff of Genentech Inc.

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