First human trial of a DNA-based vaccine for treatment of human immunodeficiency virus type 1 infection: safety and host response

J Infect Dis. 1998 Jul;178(1):92-100. doi: 10.1086/515613.


A DNA-based vaccine containing human immunodeficiency virus type 1 (HIV-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 > or = 500 per microliter of blood. Successive groups received three doses of vaccine (30, 100, or 300 microg) at 10-week intervals in a dose-escalation trial. Vaccine administration induced no local or systemic reactions, and no laboratory abnormalities were detected. Specifically, no patient developed anti-DNA antibody or muscle enzyme elevations. No consistent change occurred in CD4 or CD8 lymphocyte counts or in plasma HIV concentration. Antibody against gp120 increased in individual patients in the 100- and 300-/microg groups. Some increases were noted in cytotoxic T lymphocyte activity against gp160-bearing targets and in lymphocyte proliferative activity. The safety and potential immunogenicity of an HIV-directed DNA-based vaccine was demonstrated, a finding that should encourage further studies.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • AIDS Vaccines / administration & dosage
  • AIDS Vaccines / adverse effects
  • AIDS Vaccines / therapeutic use*
  • Adult
  • CD4 Lymphocyte Count
  • Female
  • Genes, env*
  • Genes, rev*
  • HIV Antibodies / blood
  • HIV Antibodies / immunology
  • HIV Envelope Protein gp120 / immunology
  • HIV Infections / immunology
  • HIV Infections / therapy*
  • HIV Infections / virology
  • HIV-1 / genetics
  • HIV-1 / immunology*
  • HIV-1 / physiology
  • Humans
  • Immunization Schedule
  • Lymphocyte Activation
  • Lymphocyte Count
  • Male
  • Middle Aged
  • RNA, Viral / blood
  • Semen / virology
  • T-Lymphocytes, Cytotoxic / immunology
  • Vaccines, DNA / administration & dosage
  • Vaccines, DNA / adverse effects
  • Vaccines, DNA / therapeutic use*


  • AIDS Vaccines
  • HIV Antibodies
  • HIV Envelope Protein gp120
  • RNA, Viral
  • Vaccines, DNA