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GeoVax Labs, an Atlanta-based biopharmaceutical firm developing vaccines to prevent and fight Human Immunodeficiency Virus (HIV) infections, announced that enrollment has opened for a Phase 1 trial for the company's second-generation HIV vaccine. The second-generation is identical to the first except for the addition of granulocyte-macrophage colony-stimulating factor (GM-CSF) to boost vaccine responses. GM-CSF is a naturally occurring human protein that encourages the initiation of immune responses. The second-generation vaccine co-expresses GM-CSF with HIV proteins in the DNA priming vaccinations. GM-CSF is not included in the MVA boost for the GeoVax DNA prime-MVA boost regimen.
The trial, designated HVTN 094, employs a dose-escalation technique to assess the safety and immunogenicity of the second-generation vaccine. The second-generation vaccine achieved a 90% per exposure reduction in infection in the non-human primate model. This represents a significant improvement over the first-generation. The difference in vaccine efficacy translates into 70% of vaccinated animals being protected against 12 repeated rectal challenges. GeoVax anticipates the second-generation vaccine to be moved through into Phase 2a/2b efficacy testing.
The HVTN 094 trial will include 40 vaccinated and 8 control/placebo subjects who will be examined at four sites across the U.S.: the University of Alabama at Birmingham; Brigham and Women's Hospital, Boston; the University of Rochester, and the San Francisco Department of Public Health. The initial inoculation was administered in Boston at Brigham and Women's Hospital. The National Institute of Allergy and Infectious Diseases will fund the trial through the HIV Vaccine Trials Network.
Robert McNally, Ph.D, President and Chief Executive Officer of GeoVax, said, "We are extremely pleased the HVTN is conducting the trial with the adjuvanted vaccine. They have substantial experience with our unadjuvanted vaccine and possess appropriate expertise for this first human trial of our GM-CSF co-expressing vaccine that has shown such good promise in preclinical studies."
For more information, please visit geovax.com
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