Effect of therapeutic immunization with HIV type 1 recombinant glycoprotein 160 ImmunoAG vaccine in HIV-infected individuals with CD4+ T cell counts of >or=500 and 200-400/mm3 (AIDS Clinical Trials Group Study 246/946)

AIDS Res Hum Retroviruses. 2001 Oct 10;17(15):1371-8. doi: 10.1089/088922201753197033.


AIDS Clinical Trials Group (ACTG) 246/946 was a double-blinded, randomized, controlled trial of HIV-1 MN rgp160 ImmunoAG vaccine in HIV-infected patients with CD4(+) T cell counts >or=500 and 200-400/mm(3). The main objectives were to study the safety and immunogenicity of this vaccine and to study the persistence of the immune responses after vaccination over a longer period of time. Fifteen patients with CD4(+) T cell counts of >or=500/mm(3) were enrolled in the ACTG 246 study. ACTG 246 patients received a monthly injection of vaccine or control for 6 months and then injections every 2 months. After completion of this study, seven new patients with CD4(+) T cell counts of 200-400/mm(3) entered into the ACTG 946 study. These study patients received highly active antiretroviral therapy (HAART) (ritonavir, didanosine, and stavudine) for 9 weeks to stabilize their viral load and then each patient received a monthly injection of vaccine or control substance for 6 months with HAART. The study of these two relatively small populations showed that the vaccine was safe without any adverse effect both in the patients with CD4(+) T cell counts of >or=500 and 200-400/mm(3). The vaccine was also immunogenic in patients with CD4(+) T cell counts of >or=500/mm(3) as measured by gp160-specific lymphocyte proliferative responses, and it persisted after they had received more than six vaccine injections, for a longer period of time.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • AIDS Vaccines / adverse effects
  • AIDS Vaccines / immunology
  • AIDS Vaccines / therapeutic use*
  • Animals
  • CD4 Lymphocyte Count
  • CD4-Positive T-Lymphocytes / immunology
  • Chlorocebus aethiops
  • Consumer Product Safety
  • Double-Blind Method
  • HIV Envelope Protein gp160 / adverse effects
  • HIV Envelope Protein gp160 / immunology
  • HIV Envelope Protein gp160 / therapeutic use*
  • HIV Infections / prevention & control
  • HIV Infections / therapy*
  • HIV-1 / immunology*
  • Humans
  • Recombinant Fusion Proteins / adverse effects
  • Recombinant Fusion Proteins / immunology
  • Recombinant Fusion Proteins / therapeutic use
  • T-Lymphocytes, Cytotoxic / immunology
  • Vaccination
  • Vaccines, Synthetic / adverse effects
  • Vaccines, Synthetic / immunology
  • Vaccines, Synthetic / therapeutic use*
  • Vero Cells


  • AIDS Vaccines
  • HIV Envelope Protein gp160
  • Recombinant Fusion Proteins
  • Vaccines, Synthetic