GeoVax's preventative vaccine is currently in Phase 2a human trials, which began in February 2009. The trial is only the fifth Phase 2a trial to be conducted by the HIV Vaccine Trials Network, which has conducted more than eighty Phase 1 trials. The first injections took place at the University of Alabama, Birmingham and at Vanderbilt University in Nashville. The Phase 2a human trials will include a total of 225 volunteers, 150 of whom will receive the actual vaccine while the others receive placebo injections. There are 13 participating sites, 11 of which are in North America and two of which are in Peru.
GeoVax is currently in the process of submitting an Investigational New Drug (IND) application for the initial testing of the therapeutic use of its vaccine. If the FDA has no objections, the Company plans to start Phase I therapeutic clinical trials during the first quarter of 2010. The initial trial will be conducted in Atlanta and enroll individuals who began successful antiretroviral therapy within one year of documented infection. The simian prototype of the GeoVax vaccine has had excellent success in controlling established infections in the non human primate model.
Dr. McNally concluded, "Our HIV/AIDS vaccines are designed to elicit protective antibody and protective T cells. For the preventative application of our vaccine, the purpose of the antibody is to block virus before it infects cells and the goal for the T cells is to recognize and kill cells infected by virus that escaped the antibody. For the therapeutic application, the T cells will likely play the major role in protection because of their ability to kill (eliminate) alre
|SOURCE GeoVax Labs, Inc.|
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