Abstract
Needle-free delivery of a six-plasmid HIV-1 DNA vaccine encoding EnvA, EnvB, EnvC, and subtype B Gag, Pol, and Nef underwent open-label evaluation in 15 subjects; 14 completed the 0, 1, 2 month vaccination schedule. T cell responses to HIV-specific peptide pools were detected by intracellular cytokine staining of CD4(+) [13/14 (93%)] and CD8(+) [5/14 (36%)], and by ELISpot in 11/14 (79%). Ten of 14 (71%) had ELISA antibody responses to Env proteins. Compared to a four-plasmid product, Gag- and Nef-specific T cell responses were improved, while Env-specific responses were maintained. This candidate vaccine has now advanced to Phase II evaluation.
Publication types
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Clinical Trial, Phase I
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Research Support, N.I.H., Intramural
MeSH terms
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AIDS Vaccines / administration & dosage*
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AIDS Vaccines / adverse effects
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AIDS Vaccines / genetics
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AIDS Vaccines / immunology
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Adolescent
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Adult
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CD4-Positive T-Lymphocytes / immunology
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CD8-Positive T-Lymphocytes / immunology
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Female
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Gene Products, env / immunology
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Gene Products, gag / immunology
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Gene Products, nef / immunology
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HIV Antibodies / biosynthesis
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HIV Antibodies / immunology
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HIV Infections / immunology
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HIV Infections / prevention & control*
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HIV Infections / virology
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HIV-1 / genetics
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HIV-1 / immunology*
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Humans
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Immunity, Cellular / immunology
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Male
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Plasmids / genetics
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Plasmids / immunology
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Vaccines, Combined / administration & dosage
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Vaccines, Combined / adverse effects
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Vaccines, Combined / genetics
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Vaccines, Combined / immunology
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Vaccines, DNA / administration & dosage*
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Vaccines, DNA / adverse effects
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Vaccines, DNA / genetics
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Vaccines, DNA / immunology
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nef Gene Products, Human Immunodeficiency Virus
Substances
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AIDS Vaccines
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Gene Products, env
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Gene Products, gag
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Gene Products, nef
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HIV Antibodies
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Vaccines, Combined
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Vaccines, DNA
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nef Gene Products, Human Immunodeficiency Virus