A phase I study of vaccination with NY-ESO-1f peptide mixed with Picibanil OK-432 and Montanide ISA-51 in patients with cancers expressing the NY-ESO-1 antigen

Int J Cancer. 2011 Dec 15;129(12):2836-46. doi: 10.1002/ijc.25955. Epub 2011 Mar 29.


We conducted a phase I clinical trial of a cancer vaccine using a 20-mer NY-ESO-1f peptide (NY-ESO-1 91-110) that includes multiple epitopes recognized by antibodies, and CD4 and CD8 T cells. Ten patients were immunized with 600 μg of NY-ESO-1f peptide mixed with 0.2 KE Picibanil OK-432 and 1.25 ml Montanide ISA-51. Primary end points of the study were safety and immune response. Subcutaneous injection of the NY-ESO-1f peptide vaccine was well tolerated. Vaccine-related adverse events observed were fever (Grade 1), injection-site reaction (Grade 1 or 2) and induration (Grade 2). Vaccination with the NY-ESO-1f peptide resulted in an increase or induction of NY-ESO-1 antibody responses in nine of ten patients. The sera reacted with recombinant NY-ESO-1 whole protein as well as the NY-ESO-1f peptide. An increase in CD4 and CD8 T cell responses was observed in nine of ten patients. Vaccine-induced CD4 and CD8 T cells responded to NY-ESO-1 91-108 in all patients with various HLA types with a less frequent response to neighboring peptides. The findings indicate that the 20-mer NY-ESO-1f peptide includes multiple epitopes recognized by CD4 and CD8 T cells with distinct specificity. Of ten patients, two with lung cancer and one with esophageal cancer showed stable disease. Our study shows that the NY-ESO-1f peptide vaccine was well tolerated and elicited humoral, CD4 and CD8 T cell responses in immunized patients.

Publication types

  • Clinical Trial, Phase I
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antigens / biosynthesis
  • Antigens, Neoplasm / immunology*
  • CD4-Positive T-Lymphocytes / immunology
  • CD8-Positive T-Lymphocytes / immunology
  • Cancer Vaccines / adverse effects
  • Cancer Vaccines / immunology
  • Cancer Vaccines / therapeutic use*
  • Female
  • Humans
  • Immunity, Humoral
  • Male
  • Mannitol / analogs & derivatives*
  • Mannitol / immunology
  • Membrane Proteins / immunology*
  • Middle Aged
  • Neoplasms / immunology
  • Neoplasms / therapy*
  • Oleic Acids / immunology*
  • Peptide Fragments / immunology*
  • Picibanil / immunology
  • Treatment Outcome
  • Vaccines, Subunit / therapeutic use*


  • Antigens
  • Antigens, Neoplasm
  • CTAG1B protein, human
  • Cancer Vaccines
  • Membrane Proteins
  • NY-ESO-1 protein, human (91-110)
  • Oleic Acids
  • Peptide Fragments
  • Vaccines, Subunit
  • montanide ISA 51
  • Picibanil
  • Mannitol