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Active Immunization of Asymptomatic, HIV-Infected Individuals With Recombinant GP160 HIV-1 Antigen: A Phase I/II Study of Immunogenicity and Toxicity

National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov · Datasets · License: Public Domain
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hiv-1hiv-infectionssyntheticvaccines
To determine the minimal effective (immunogenic) dose of vaccine in asymptomatic HIV-1 seropositive individuals with \> 400 cells/mm3 (CD4). To determine the dose-response to a 4 fold escalation of the immunizing dose. To describe both cellular and humoral immune responses to HIV-1 in the immunized individuals. To describe the effects of this immunization on general immunological, virological and clinical parameters. To evaluate the safety of injecting recombinant gp160 in this population. To evaluate the extent of variability between different lots of gp160 (arms C1 and C2). It might be possible to increase immune responses or to induce new types of immune responses to HIV in some infected individuals by means of a vaccine, which could result in an immunological, virological or clinical benefit.
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