Development of a vaccine able to prevent HIV infection would play a major role in managing the spread of HIV. A recently developed class of vaccines that use DNA as the immunizing agent offers a promising approach because genetic vaccination in animal models results in a broader immune response, including the induction of cytotoxic T cell responses, than protein vaccines can achieve. Apollon, Inc. has developed a genetic vaccine encoding the envelope protein of HIV-1 that has been shown to be immunogenic in animal studies and has undergone early evaluation as an immunomodulating agent in HIV- infected patients. In collaboration with Apollon, Inc., we have undertaken a study in up to 25 individuals not infected with HIV. The study will involve administration of four doses of the genetic vaccine or a similarly constituted vehicle control over a 6-month period, with a followup of 6 additional months. The study will focus on evaluating the safety and immunogenicity of this candidate vaccine, including its ability to induce cytotoxic T cell responses.
