Safety and Immunogenicity of a Randomized Phase 1 Prime-Boost Trial With ALVAC-HIV (vCP205) and Oligomeric Glycoprotein 160 From HIV-1 Strains MN and LAI-2 Adjuvanted in Alum or Polyphosphazene

The Journal of Infectious Diseases
Robert J O'ConnellJerome H Kim

Abstract

Prime-boost regimens comprising ALVAC-HIV (prime) and human immunodeficiency virus type 1 (HIV) Env (boost) induce HIV-specific neutralizing antibody and cell-mediated immune responses, but the impact of boost schedule and adjuvant requires further definition. A phase 1 trial was conducted. In part A (open label), 19 volunteers received oligomeric glycoprotein 160 from HIV strains MN and LAI-2 (ogp160 MN/LAI-2) with dose escalation (25, 50, 100 μg) and either polyphosphazene (pP) or alum adjuvant. In part B, 72 volunteers received either placebo (n=12) or recombinant canarypox virus expressing HIV antigens (ALVAC-HIV [vCP205]) with different doses and schedules of ogp160 MN/LAI-2 in pP or alum (n = 60). The vaccines were safe and well tolerated, with no vaccine-related serious adverse events. Anti-gp70 V1V2 antibody responses were detected in 17 of 19 part A volunteers (89%) and 10%-100% of part B volunteers. Use of a peripheral blood mononuclear cell-based assay revealed that US-1 primary isolate neutralization was induced in 2 of 19 recipients of ogp160 protein alone (10.5%) and 5 of 49 prime-boost volunteers (10.2%). Among ogp160 recipients, those who received pP were more likely than those who received alum to have serum th...Continue Reading

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Sep 9, 2016·Current Opinion in HIV and AIDS·Mangala Rao, Carl R Alving
Dec 8, 2020·Journal of Controlled Release : Official Journal of the Controlled Release Society·Alexander K Andrianov, Robert Langer
Jan 22, 2021·Nanomedicine : Nanotechnology, Biology, and Medicine·Alexander MarinAlexander K Andrianov
Nov 23, 2019·Materials Science & Engineering. C, Materials for Biological Applications·Alexander K AndrianovThomas R Fuerst
Jan 29, 2022·Current HIV/AIDS Reports·Brittany Ober ShepherdKayvon Modjarrad

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