Abstract
The safety and immunogenicity of plasmid pTHr DNA, modified vaccinia virus Ankara (MVA) human immunodeficiency virus type 1 (HIV-1) vaccine candidates were evaluated in four Phase I clinical trials in Kenya and Uganda. Both vaccines, expressing HIV-1 subtype A gag p24/p17 and a string of CD8 T-cell epitopes (HIVA), were generally safe and well-tolerated. At the dosage levels and intervals tested, the percentage of vaccine recipients with HIV-1-specific cell-mediated immune responses, assessed by a validated ex vivo interferon gamma (IFN-gamma) ELISPOT assay and Cytokine Flow Cytometry (CFC), did not significantly differ from placebo recipients. These trials demonstrated the feasibility of conducting high-quality Phase 1 trials in Africa.
Publication types
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Clinical Trial, Phase I
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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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Adult
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Epitopes, T-Lymphocyte / genetics
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Epitopes, T-Lymphocyte / immunology
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Female
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Flow Cytometry
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Genetic Vectors
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HIV-1 / immunology*
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Humans
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Interferon-gamma / biosynthesis
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Kenya
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Leukocytes, Mononuclear / immunology
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Male
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Placebos / administration & dosage
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Plasmids
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Uganda
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Vaccines, DNA / genetics
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Vaccines, DNA / immunology*
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Vaccinia virus / genetics
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gag Gene Products, Human Immunodeficiency Virus / genetics
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gag Gene Products, Human Immunodeficiency Virus / immunology
Substances
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AIDS Vaccines
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Epitopes, T-Lymphocyte
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Placebos
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Vaccines, DNA
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gag Gene Products, Human Immunodeficiency Virus
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Interferon-gamma