GeoVax Labs, Inc. (OTCQB/OTCBB: GOVX), an Atlanta-based biopharmaceutical firm developing vaccines to prevent and fight Human Immunodeficiency Virus (HIV) infections, today announced that the NIH-funded HIV Vaccine Trials Network (HVTN) has opened enrollment for a Phase 1 trial for the company's second-generation HIV vaccine. The second-generation vaccine is identical to the first generation (currently in a Phase 2a clinical trial) except for the inclusion of granulocyte-macrophage colony-stimulating factor (GM-CSF) as an adjuvant (additive) to enhance vaccine responses. GM-CSF is a normal human protein that promotes the initiation of immune responses. GeoVax's 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 to evaluate the safety and immunogenicity of the GM-CSF adjuvanted vaccine. In the non-human primate model, co-expression of GM-CSF in the DNA prime achieved a 90% per exposure reduction in infection, a significant improvement over the unadjuvanated vaccine. This difference in vaccine efficacy translated into 70% of vaccinated animals being protected against 12 repeated rectal challenges. Assuming a successful outcome, the company expects the adjuvanted version of the vaccine to be carried forward into Phase 2a/2b efficacy testing.
The HVTN 094 trial will enroll a total of 40 vaccinated and 8 control/placebo subjects to be studied at four sites nationwide: 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 first inoculation was given at Brigham and Women's Hospital, Boston. Funding for HVTN's conduct of the trial will come from the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH).
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."
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