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.

J S Lambert, M Keefer, M J Mulligan, D Schwartz, J Mestecky, K Weinhold, C Smith, R Hsieh, Z Moldoveanu, P Fast, B Forrest, W Koff

Journal: Vaccine 2001;19(23-24):3033-42

PMID: 11311997

Full Text on Elsevier Science View on PubMed

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.

Address: Institute of Human Virology, University of Maryland, 725 West Lombard Street, Baltimore, MD21201, USA. [email protected]

DOI: 10.1016/s0264-410x(01)00051-2

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MeSH Terms: AIDS Vaccines, Adjuvants, Immunologic, Administration, Oral, Adult, Aluminum Hydroxide, Antibody-Producing Cells, Female, HIV Antibodies, HIV Envelope Protein gp120, HIV Seronegativity, HIV-1, Humans, Immunity, Cellular, Immunity, Mucosal, Immunization, Secondary, In Vitro Techniques, Lymphocyte Activation, Male, Microspheres, Middle Aged, Peptide Fragments, Safety, T-Lymphocytes, Cytotoxic