AIDSWEEKLY Plus; Monday, May 14, 2001
Prepared by AIDS Weekly editors from staff and other reports

NewsRx - The independent organization that is overseeing the final-stage clinical trials VaxGen, Inc.'s preventive AIDSVAX vaccine indicated, once again, that the product appears safe and that the trials are being conducted appropriately.

VaxGen, Inc. (VXGN), made the announcement on April 12, 2001. VaxGen said that an average of 95% of volunteers continue to participate in the Phase III trials.

In its fifth review of VaxGen's trials, the Data and Safety Monitoring Board (DSMB) found that the vaccine continues to exhibit a high safety profile. More than 23,000 injections of AIDSVAX have been administered since it entered human clinical trials.

AIDSVAX is made from a synthetic protein and contains no genetic material, so it is incapable of causing HIV infection. Two formulations of the vaccine are being tested in separate trials - one in North America and Europe and a second in Thailand - involving nearly 8,000 volunteers. The double-blind trials provide a series of inoculations to volunteers during the course of 36 months. Some of the trial volunteers receive vaccine and the remaining receive placebo. The volunteers, the clinics that administer the injections, and VaxGen do not know who gets the vaccine or the placebo. At the end of the trials, the vaccine's effectiveness is calculated by comparing the rate of HIV infection between the two groups.

Those who volunteered for the trials continue to participate according to the company's expectations. On an annualized basis, 94.7% of the volunteers in the North American/European trial continued to participate in the trial as of March 18, 2001, VaxGen said. The annualized retention rate for the Thai trial was 97.4% as of the same date.

All of the DSMB's reviews to date have focused on safety and trial conduct. Looking ahead, the DSMB is scheduled to conduct its first review in November 2001 to examine how well AIDSVAX prevents HIV infection. If this interim efficacy analysis, which will examine data from VaxGen's trial in North America and Europe, shows that the vaccine is effective at a high level of statistical confidence, VaxGen expects that the trial would be halted early. The company would then begin the process of applying for regulatory approval. If the interim analysis is inconclusive, the trial will proceed to its scheduled conclusion in the fourth quarter of 2002. The additional 12 months of testing, if necessary, would generate additional statistical power with which to determine the vaccine's efficacy.

This article was prepared by AIDS Weekly editors from staff and other reports.

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