Abstract
The tolerability and immunogenicity of the hepatitis C virus E1 protein as a candidate vaccine was examined in a Phase I, single-arm study. Twenty healthy male volunteers were injected in the deltoid muscle at weeks 0, 3 and 6 with 20 microg recombinant E1 adsorbed on alum. A fourth (booster) dose was administered to 19 subjects at week 26. The candidate therapeutic vaccine was well tolerated. Three vaccine doses induced a clear humoral anti-E1 response that was boosted by a fourth dose. A strong, specific cellular immune response towards E1 was elicited in all vaccine recipients, which included a clear Th1 type response in all but one of the subjects.
Publication types
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Clinical Trial
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Clinical Trial, Phase I
MeSH terms
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Adolescent
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Adult
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Antibody Formation / immunology
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Hepatitis C / immunology*
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Hepatitis C / prevention & control*
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Hepatitis C Antibodies / analysis
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Hepatitis C Antibodies / biosynthesis
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Humans
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Immunity, Cellular / immunology
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Immunization, Secondary
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Injections, Intramuscular
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Interferon-gamma / analysis
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Interferon-gamma / biosynthesis
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Interleukin-5 / analysis
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Interleukin-5 / biosynthesis
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Lymphocyte Count
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Male
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Middle Aged
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T-Lymphocytes / immunology
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Vaccines, Synthetic / immunology
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Viral Envelope Proteins / adverse effects
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Viral Envelope Proteins / immunology*
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Viral Vaccines / administration & dosage
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Viral Vaccines / adverse effects
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Viral Vaccines / immunology*
Substances
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E1 protein, Hepatitis C virus
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Hepatitis C Antibodies
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Interleukin-5
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Vaccines, Synthetic
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Viral Envelope Proteins
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Viral Vaccines
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Interferon-gamma