A Phase I safety and immunogenicity trial of UBI (R) microparticulate monovalent HIV-1 MN oral peptide immunogen with parenteral boost in HIV-1 seronegative human subjects

Thirty-three HIV-seronegative adults were recruited into a Phase I safety a nd immunogenicity HIV-1 vaccine trial. The immunogens were as follows: a sy nthetic, monovalent, octameric HIV-1 MN V3 peptide in aluminum hydroxide (a lum) adjuvant administered by intramuscular delivery: and a similar product encapsulated in biodegradable micro-spheres composed of co-polymers of lac tic and glycolic acids, administered by the oral route. These were administ ered in three sequential oral doses, followed by a parenteral boost. No ser ious adverse experiences were observed. Oral administration of this vaccine , alone or in combination with parenteral boosting, resulted in no signific ant humoral, cellular, or mucosal immune responses. (C) 2001 Elsevier Scien ce Ltd. All rights reserved.