Abstract
Norwalk virus-like particles (VLPs), made from recombinant capsid protein, are a promising vaccine. Thirty-six healthy adult volunteers received 250 microg (n = 10), 500 microg (n = 10), or 2000 microg (n = 10) of orally administered VLP or placebo (n = 6). All vaccinees developed significant rises in IgA anti-VLP antibody-secreting cells. Ninety percent who received 250 microg developed rises in serum anti-VLP IgG; neither the rates of seroconversion nor geometric mean titers increased at the higher doses. About 30-40% of volunteers developed mucosal anti-VLP IgA. Lymphoproliferative responses and IFN-gamma production were observed transiently among those who received 250 microg or 500 microg but not 2000 microg of VLP. Studies to increase immunogenicity using a mucosal adjuvant are planned.
Publication types
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Clinical Trial
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Research Support, U.S. Gov't, P.H.S.
MeSH terms
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Administration, Oral
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Adolescent
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Adult
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Antibodies, Viral / blood*
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Caliciviridae Infections / blood
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Caliciviridae Infections / immunology*
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Capsid / immunology
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Dose-Response Relationship, Immunologic
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Female
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Humans
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Immunity, Cellular
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Immunity, Mucosal
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Immunization*
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Immunoglobulin A, Secretory / analysis
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Immunoglobulin G / blood
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Interferon-gamma / analysis
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Intestinal Mucosa / immunology
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Male
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Norwalk virus / immunology*
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Saliva / immunology
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Vaccination
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Vaccines, Synthetic / administration & dosage
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Vaccines, Synthetic / immunology
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Vagina / immunology
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Viral Vaccines / administration & dosage
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Viral Vaccines / immunology*
Substances
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Antibodies, Viral
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Immunoglobulin A, Secretory
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Immunoglobulin G
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Vaccines, Synthetic
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Viral Vaccines
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Interferon-gamma