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 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.
Kundu-Raychaudhuri
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S
AIDS Clinical Trials Unit, Center for AIDS Research, Stanford University Medical Center, Stanford, California 94305-5107, USA. kundu@leland.stanford.edu
Sevin
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A
Kilgo
P
P
Nokta
M
M
Pollard
R B
RB
Merigan
T C
TC
D016915:AIDS Vaccines / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D000818:Animals; D018791:CD4 Lymphocyte Count; D015496:CD4-Positive T-Lymphocytes / Q000276:immunology; D002522:Chlorocebus aethiops; D003257:Consumer Product Safety; D004311:Double-Blind Method; D019302:HIV Envelope Protein gp160 / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D015658:HIV Infections / Q000517:prevention & control / Q000628:therapy*; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D011993:Recombinant Fusion Proteins / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use; D013602:T-Lymphocytes, Cytotoxic / Q000276:immunology; D014611:Vaccination; D014614:Vaccines, Synthetic / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D014709:Vero Cells
D016915:AIDS Vaccines; D019302:HIV Envelope Protein gp160; D011993:Recombinant Fusion Proteins; D014614:Vaccines, Synthetic