FIRST HUMAN TRIAL OF A DNA-BASED VACCINE FOR TREATMENT OF HUMAN-IMMUNODEFICIENCY-VIRUS TYPE-1 INFECTION - SAFETY AND HOST RESPONSE

A DNA-based vaccine containing human immunodeficiency virus type 1 (HI V-1) env and rev genes was tested for safety and host immune response In 15 asymptomatic HIV-infected patients who were not using antiviral drugs and who had CD4(+) lymphocyte counts of greater than or equal to 500 per microliter of blood. Successive groups received three doses o f vaccine (30, 100, or 300 mu g) at 10-week intervals in a dose-escala tion trial. Vaccine administration induced no local or systemic reacti ons, and no laboratory abnormalities were detected. Specifically, no p atient developed anti-DNA antibody or muscle enzyme elevations. No con sistent change occurred in CD4 or CD8 lymphocyte counts or in plasma H IV concentration. Antibody against gp120 increased in individual patie nts in the 100- and 300-mu g groups. Some increases were noted in cyto toxic T lymphocyte activity against gp160-bearing targets and in lymph ocyte proliferative activity. The safety and potential immunogenicity of an HIV-directed DNA-based vaccine was demonstrated, a finding that should encourage further studies.