The trials have two phases. The first phase will be a dose escalation to evaluate safety and immune responses. Initially, low doses of the two vaccine components will be given to 12 volunteers. If the vaccine proves safe, it will then be tested at a high dose in 36 volunteers.
If the vaccine proves safe and shows good immunogenicity in the dose escalation studies, a second phase of clinical testing will be initiated. In this phase, 72 volunteers will be used to conduct the initial studies on optimizing the dosing schedule.
The vaccine includes two inoculations of a DNA vaccine that primes the immune system to recognize HIV and two doses of subsequent booster vaccine based on a recombinant MVA poxvirus.
The vaccine produces the three major proteins expressed by HIV and is expected to induce the immune system to respond to these distinguishing features of HIV should the actual virus appear.
The trials include testing of both DNA and MVA components of the vaccine developed by a team of researchers at GeoVax, the Yerkes National Primate Research Center at Emory University and the Emory Vaccine Center, along with colleagues at the National Institutes of Health and the Centers for Disease Control and Prevention (CDC).