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).

Abstract

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.

• Authors: S Kundu-Raychaudhuri, A Sevin, P Kilgo, M Nokta, R B Pollard, T C Merigan
• Journal: AIDS research and human retroviruses (AIDS Res Hum Retroviruses) Vol. 17 Issue 15 Pg. 1371-8 (Oct 10 2001) ISSN: 0889-2229 [Print] United States
• PMID: 11679149 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, U.S. Gov't, P.H.S.)

Chemical References

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

Topics

• AIDS Vaccines (adverse effects, immunology, 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, immunology, therapeutic use)
• HIV Infections (prevention & control, therapy)
• HIV-1 (immunology)
• Humans
• Recombinant Fusion Proteins (adverse effects, immunology, therapeutic use)
• T-Lymphocytes, Cytotoxic (immunology)
• Vaccination
• Vaccines, Synthetic (adverse effects, immunology, therapeutic use)
• Vero Cells