In large scale preclinical vaccine trials conducted at the Emory University Yerkes National Primate Research Center in collaboration with NIAID and CDC, 22 of 23 non-human primates [monkeys] vaccinated with the GeoVax DNA (immunity priming) and rMVA (immunity boosting) vaccine have been protected against AIDS for over three years. Five out of six non-vaccinated primates died within eight months of exposure to the AIDS-inducing challenge virus.
We conduct vaccine manufacturing process development and test development in our laboratory facilities where we are developing and refining vaccine seed stock preparations, manufacturing processes and final product formulations for seamless transfer to contract laboratories. The manufacture of GeoVax vaccines for use in Phase I, II, and III human trials is conducted under GMP/GLP [USA regulatory] guidelines in FDA approved contract laboratories.
Human trials (Phases I, II, and III) are used to evaluate the safety and effectiveness of our AIDS vaccines. To date, human trials have been conducted by the HIV Vaccine Trials Network ("HVTN") a network of vaccine trial sites operated by the NIH. In the future, trials may be conducted by the HVTN and others in the United States as well as internationally. These trials are designed to assess both the safety and the protective efficacy or effectiveness of our AIDS vaccines in the human population.
Phase I human trials of the GeoVax DNA - AIDS vaccine began in early 2003 and were successfully concluded in late 2004 with no safety problems. Several two-stage human trials evaluating various combinations of our DNA and MVA AIDS vaccines began in 2006 and will continue through 2007-2008. In these trials, our AIDS vaccines will be administered to several groups of people in order to evaluate safety and immune responses to varying doses [amounts] of vaccine. These trials are anticipated to provide substantial vaccine safety data as well as indications of potential vaccine effectiveness.