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Proc Natl Acad Sci U S A. 2004 Jul 20;101(29):10697-702. Epub 2004 Jul 13.

Recombinant NY-ESO-1 protein with ISCOMATRIX adjuvant induces broad integrated antibody and CD4(+) and CD8(+) T cell responses in humans.

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  • 1Ludwig Institute for Cancer Research, Melbourne 3084, Australia. ian.davis@ludwig.edu.au

Erratum in

  • Proc Natl Acad Sci U S A. 2005 Jul 5;102(27):9734.

Abstract

NY-ESO-1 is a "cancer-testis" antigen expressed in many cancers. ISCOMATRIX is a saponin-based adjuvant that induces antibody and T cell responses. We performed a placebo-controlled clinical trial evaluating the safety and immunogenicity of recombinant NY-ESO-1 protein with ISCOMATRIX adjuvant. Forty-six evaluable patients with resected NY-ESO-1-positive tumors received three doses of vaccine intramuscularly at monthly intervals. The vaccine was well tolerated. We observed high-titer antibody responses, strong delayed-type hypersensitivity reactions, and circulating CD8(+) and CD4(+) T cells specific for a broad range of NY-ESO-1 epitopes, including known and previously unknown epitopes. In an unplanned analysis, vaccinated patients appeared to have superior clinical outcomes to those treated with placebo or protein alone. The vaccine is safe and highly potent immunologically.

PMID:
15252201
PMCID:
PMC489997
DOI:
10.1073/pnas.0403572101
[PubMed - indexed for MEDLINE]
Free PMC Article
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