GeoVax is developing both preventative and therapeutic vaccines for HIV/AIDS
Preventative vaccines are used in uninfected people to prevent disease and transmission should the person become infected. A classic example of a preventative vaccine is the polio vaccine. Therapeutic vaccines are used in already infected people who are on successful drug treatment. The goal of the therapeutic vaccine is to raise anti-viral immune responses that will reduce the need for continuing drug treatment.
Both preventative and therapeutic preclinical vaccine trials are conducted at the Emory University Yerkes National Primate Research Center in collaboration with researchers at NIAID and the CDC. In the preventative trials, simian immunodeficiency virus (SIV) prototypes of the GeoVax HIV-1 vaccine are being tested for safety, immune responses and the ability to protect against SIV/AIDS. These trials have shown excellent protection against highly virulent chimeras of simian and human immunodeficiency viruses (SHIVs) and good protection against even more virulent SIV challenges. The results of these trials have provided the rationale for the vaccine progressing to clinical trials testing for its ability to serve as a preventative vaccine.
Preclinical therapeutic studies are being conducted in non-human primates that have been infected, placed on drugs, vaccinated, and then taken off of drugs. These trials have shown that the vaccine can supplant the need for drugs in infected animals who are treated with drugs and vaccinated soon after infection. Studies are still in progress evaluating the efficacy of the vaccine for infected animals treated with drugs closer to the time they begin to develop SIV/AIDS.
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 1, 2 and 3) are used to evaluate the safety and effectiveness of our AIDS vaccines. To date, trials for the preventative application have been conducted by the HIV Vaccine Trials Network (HVTN), a network of vaccine trial sights supported by the US National Institutes of Health. The initial therapeutic trial is currently being planned and will be supported by GeoVax.
Phase 1 preventative trials of the DNA component for the GeoVax HIV-1 vaccine began in 2003 and were successfully comnpleted in late 2004 with no safety problems. Several two stage trials combining the DNA prime with the MVA boost for our HIV/AIDS vaccine began in 2006 and were completed in late 2008. In these trials, our AIDS vaccines were administered to four groups of people to evaluate safety and immune responses to varying doses (amounts) and vaccine regimens. The excellent safety and immune responses in these trials provided the foundations for our vaccine moving into a larger phase 2a trial which initiated in 2009. This trial, termed HVTN 205 is being conducted in both North and South America and will provide more safety and immune response data to support a proof of concept trial (initial assessment of efficacy) in high risk individuals. Since its inception, the NIH sponsored trials networks have conducted more than 80 phase 1 trials. From these trials, only 5 have progressed into phase 2 trials, with the GeoVax HIV/AIDS vaccine being the 5th.
The first therapeutic trial for the GeoVax HIV/AIDS vaccine will be a non-blinded study in infected individuals who started drug treatment during their first year of infection. The start of this phase 1 therapeutic trial is targeted for late 2009.