Abstract
Thirty-three HIV-seronegative adults were recruited into a Phase I safety and immunogenicity HIV-1 vaccine trial. The immunogens were as follows: a synthetic, monovalent, octameric HIV-1 MN V3 peptide in aluminum hydroxide (alum) adjuvant administered by intramuscular delivery; and a similar product encapsulated in biodegradable micro-spheres composed of co-polymers of lactic and glycolic acids, administered by the oral route. These were administered in three sequential oral doses, followed by a parenteral boost. No serious adverse experiences were observed. Oral administration of this vaccine, alone or in combination with parenteral boosting, resulted in no significant humoral, cellular, or mucosal immune responses.
Publication types
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Clinical Trial
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Clinical Trial, Phase I
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Multicenter Study
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
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Research Support, U.S. Gov't, P.H.S.
MeSH terms
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AIDS Vaccines / administration & dosage*
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AIDS Vaccines / adverse effects
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AIDS Vaccines / immunology
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Adjuvants, Immunologic / administration & dosage
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Administration, Oral
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Adult
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Aluminum Hydroxide / administration & dosage
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Antibody-Producing Cells / immunology
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Female
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HIV Antibodies / biosynthesis
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HIV Envelope Protein gp120 / administration & dosage*
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HIV Envelope Protein gp120 / adverse effects
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HIV Envelope Protein gp120 / immunology
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HIV Seronegativity / immunology
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HIV-1 / immunology
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Humans
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Immunity, Cellular
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Immunity, Mucosal
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Immunization, Secondary
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In Vitro Techniques
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Lymphocyte Activation
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Male
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Microspheres
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Middle Aged
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Peptide Fragments / administration & dosage*
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Peptide Fragments / adverse effects
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Peptide Fragments / immunology
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Safety
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T-Lymphocytes, Cytotoxic / immunology
Substances
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AIDS Vaccines
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Adjuvants, Immunologic
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HIV Antibodies
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HIV Envelope Protein gp120
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HIV envelope protein gp120 (305-321)
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Peptide Fragments
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Aluminum Hydroxide