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• W2305782014 abstract "Background. 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. Methods. 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). Results. 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 that neutralized tier 2 viruses (12% vs 0%; P = .015). Conclusions. Administration of ogp160 with pP induces primary isolate tier 2 neutralizing antibody responses in a small percentage of volunteers, demonstrating proof of concept and underscoring the importance of further optimization of prime-boost strategies for HIV infection prevention. Clinical Trials Registration. NCT00004579." @default.
• W2305782014 created "2016-06-24" @default.
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• W2305782014 date "2016-02-11" @default.
• W2305782014 modified "2023-10-18" @default.
• W2305782014 title "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" @default.
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• W2305782014 doi "https://doi.org/10.1093/infdis/jiw059" @default.
• W2305782014 hasPubMedCentralId "https://www.ncbi.nlm.nih.gov/pmc/articles/4878724" @default.
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• W2305782014 hasPublicationYear "2016" @default.
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