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(讨论)乙肝的病位真的在肝吗?
The following is the a more detailed report about the AIDA vaccine in Thailand.
November 12, 2003 – VaxGen, Inc. announced preliminary results from its randomized, double-blind, placebo-controlled Phase III clinical trial in Thailand to evaluate AIDSVAX B/E, an investigational vaccine (rgp 120) for the prevention of HIV infection.
The vaccine candidate did not show efficacy for either the primary or secondary endpoints. The primary endpoint for the trial was the prevention of infection by HIV, the virus that causes AIDS. The secondary endpoints concerned whether vaccination slowed the progression of disease among those who received the vaccine but later became infected with HIV. The vaccine candidate appeared to be well tolerated with no serious adverse events related to the vaccine. The vaccine cannot cause HIV infection.
The trial was well conducted in accordance with international good clinical practices. Extensive education and risk-reduction counseling were provided during the trial. Data indicate that study volunteers reported marked reductions in behaviors, including sharing of needles, associated with HIV infection.
The trial results were analyzed by scientists from the Bangkok Vaccine Evaluation Group (BVEG), the U.S. Centers for Disease Control and Prevention (CDC), the Statistical Center for HIV/AIDS Research and Prevention (SCHARP) of the Fred Hutchinson Cancer Research Center, and VaxGen.
About the Phase III Clinical Trial of AIDSVAX B/E
The trial was designed to evaluate the safety and efficacy of AIDSVAX B/E, primarily against the blood-borne transmission of HIV subtype E and one strain of HIV subtype B. The study volunteers were 2,546 injecting drug users in Bangkok, Thailand. During the 36-month trial, a total of seven injections were administered at months 0, 1, 6, 12, 18, 24 and 30. The ratio of vaccine to placebo recipients was 1:1.
During the trial, 105 volunteers who received placebo became infected with HIV; 106 volunteers who received at least one injection of AIDSVAX B/E became infected. The annualized infection rate in placebo and vaccine recipients was 3.1%.
The trial was conducted at 17 clinical sites in the greater Bangkok Metropolitan Area. Trial volunteers received education and counseling every six months to avoid behavior that could lead to HIV infection and were advised to assume that they may have received a placebo or that the vaccine might be ineffective.
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