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AIDSVAX Shows Continuing Safety Profile.(Brief Article)
2001 MAY 16 - (NewsRx.com & NewsRx.net) --
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 ...
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