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  • Title: A Phase I safety and immunogenicity trial of UBI microparticulate monovalent HIV-1 MN oral peptide immunogen with parenteral boost in HIV-1 seronegative human subjects.
    Author: Lambert JS, Keefer M, Mulligan MJ, Schwartz D, Mestecky J, Weinhold K, Smith C, Hsieh R, Moldoveanu Z, Fast P, Forrest B, Koff W.
    Journal: Vaccine; 2001 Apr 30; 19(23-24):3033-42. PubMed ID: 11311997.
    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.
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