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

S. Kundu-Raychaudhuri, A. Sevin, P. Kilgo, M. Nokta, Richard B Pollard, T. C. Merigan

Research output: Contribution to journalArticle

8 Citations (Scopus)

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 ≥500 and 200-400/mm3. 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 ≥500/mm3 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/mm3 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 ≥500 and 200-400/mm3. The vaccine was also immunogenic in patients with CD4+ T cell counts of ≥500/mm3 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.

Original languageEnglish (US)
Pages (from-to)1371-1378
Number of pages8
JournalAIDS Research and Human Retroviruses
Volume17
Issue number15
DOIs
StatePublished - 2001
Externally publishedYes

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AIDS Vaccines
Therapeutic Uses
CD4 Lymphocyte Count
HIV-1
Immunization
Glycoproteins
Acquired Immunodeficiency Syndrome
Clinical Trials
T-Lymphocytes
Vaccines
Injections
Highly Active Antiretroviral Therapy
Stavudine
Didanosine
Ritonavir
Viral Load
Vaccination
Randomized Controlled Trials
Lymphocytes
Safety

ASJC Scopus subject areas

  • Immunology
  • Virology

Cite this

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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 ≥500 and 200-400/mm3. 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 ≥500/mm3 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/mm3 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 ≥500 and 200-400/mm3. The vaccine was also immunogenic in patients with CD4+ T cell counts of ≥500/mm3 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.",
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AU - Pollard, Richard B

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