GeoVax Labs Inc.is a technology company that creates, develops and tests innovative HIV/AIDS vaccine. The company today announced that it is now allowed by the US Food and Drug Administration (FDA) to begin a Phase 1 clinical trial for Geovax’s therapeutic vaccine, which is intended as a treatment for HIV.
The company will begin a non-blinded study in HIV infected individuals who started drug treatment during their first year of infection. The protocol for the clinical trial was conceived in collaboration with the AIDS Research Consortium of Atlanta (ARCA). The Phase 1 trial will carefully monitor safety while evaluating the ability of the vaccine to elicit protective immune responses in vaccinated participants. The trial is based on the achievement of post-vaccine viral control in animal studies conducted in recently infected non-human primates at the Yerkes National Primate Research Center which is affiliated with Emory University.
This trial will enable GeoVax to gather crucial information toward the vaccine’s success on a more timely basis than the time required to perform a preventative trial. The very next step in the process for GeoVax will be a submission by ARCA to the IRB (Institutional Review Board) for local review of trial documentation, a standard requirement to protect human subjects.
An unmet need exists in the market for a HIV therapeutic vaccine which can reduce the need for expensive and poorly tolerated life-long oral medications currently available to infected individuals. The president and CEO of GeoVax, Robert McNally, Ph.D., commented on the start of Phase 1 trials, “Based upon pre-clinical animal data, we believe our therapeutic vaccine may improve treatment options for people infected with HIV.”