Abstract
This randomized double-blind study aimed to determine the safety and immunogenicity of a gp120/NefTat candidate human immunodeficiency virus type 1 (HIV-1) vaccine formulated with one of three different Adjuvant Systems (AS02(A), AS02(V) and AS01(B)) in healthy HIV-seronegative adults. All vaccine formulations induced strong HIV-specific CD4(+) T-cell responses characterized by high lymphoproliferative capacity and IL-2 production that were still detectable 18 months after last immunization, with strongest responses seen in the AS01(B) group. Broad coverage was demonstrated against gp120, and to a lesser extent Nef, derived from the most common circulating clades (B, C and circulating recombinant form [CRF]-01). All vaccine formulations exhibited acceptable safety and reactogenicity profiles. The demonstration of superior CD4(+) T-cell induction by AS01(B) provides important guidance for future HIV vaccine development.
Copyright © 2010. Published by Elsevier Ltd.
Publication types
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Comparative Study
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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AIDS Vaccines / adverse effects
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AIDS Vaccines / immunology*
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Adjuvants, Immunologic / pharmacology
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Adolescent
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Adult
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Antibodies, Neutralizing / blood
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CD4-Positive T-Lymphocytes / immunology*
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Cross Reactions
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Double-Blind Method
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Female
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HIV Antibodies / blood
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HIV Envelope Protein gp120 / immunology*
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HIV Infections / immunology
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HIV Infections / prevention & control*
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HIV-1 / immunology
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Humans
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Immunity, Cellular
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Interleukin-2 / immunology
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Male
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Middle Aged
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Young Adult
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nef Gene Products, Human Immunodeficiency Virus / immunology*
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tat Gene Products, Human Immunodeficiency Virus / immunology*
Substances
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AIDS Vaccines
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Adjuvants, Immunologic
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Antibodies, Neutralizing
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HIV Antibodies
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HIV Envelope Protein gp120
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IL2 protein, human
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Interleukin-2
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gp120 protein, Human immunodeficiency virus 1
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nef Gene Products, Human Immunodeficiency Virus
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nef protein, Human immunodeficiency virus 1
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tat Gene Products, Human Immunodeficiency Virus