title: 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.
abstract: 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.
authors: Department of Immunotherapeutics, University of Tokyo Hospital, Tokyo, Japan.
authors: Kazuhiro
authors: K
authors: Kakimi
authors: Midori
authors: M
authors: Isobe
authors: Akiko
authors: A
authors: Uenaka
authors: Hisashi
authors: H
authors: Wada
authors: Eiichi
authors: E
authors: Sato
authors: Yuichiro
authors: Y
authors: Doki
authors: Jun
authors: J
authors: Nakajima
authors: Yasuyuki
authors: Y
authors: Seto
authors: Tomoki
authors: T
authors: Yamatsuji
authors: Yoshio
authors: Y
authors: Naomoto
authors: Kenshiro
authors: K
authors: Shiraishi
authors: Nagio
authors: N
authors: Takigawa
authors: Katsuyuki
authors: K
authors: Kiura
authors: Kazuhide
authors: K
authors: Tsuji
authors: Keiji
authors: K
authors: Iwatsuki
authors: Mikio
authors: M
authors: Oka
authors: Linda
authors: L
authors: Pan
authors: Eric W
authors: EW
authors: Hoffman
authors: Lloyd J
authors: LJ
authors: Old
authors: Eiichi
authors: E
authors: Nakayama
mesh_terms: D000328:Adult; D000368:Aged; D000941:Antigens / Q000096:biosynthesis; D000951:Antigens, Neoplasm / Q000276:immunology*; D015496:CD4-Positive T-Lymphocytes / Q000276:immunology; D018414:CD8-Positive T-Lymphocytes / Q000276:immunology; D019496:Cancer Vaccines / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D056724:Immunity, Humoral; D008297:Male; D008353:Mannitol / Q000031:analogs & derivatives* / Q000276:immunology; D008565:Membrane Proteins / Q000276:immunology*; D008875:Middle Aged; D009369:Neoplasms / Q000276:immunology / Q000628:therapy*; D009829:Oleic Acids / Q000276:immunology*; D010446:Peptide Fragments / Q000276:immunology*; D010844:Picibanil / Q000276:immunology; D016896:Treatment Outcome; D022223:Vaccines, Subunit / Q000627:therapeutic use*
chemical_list: D000941:Antigens; D000951:Antigens, Neoplasm; C104948:CTAG1B protein, human; D019496:Cancer Vaccines; D008565:Membrane Proteins; C568699:NY-ESO-1 protein, human (91-110); D009829:Oleic Acids; D010446:Peptide Fragments; D022223:Vaccines, Subunit; C477385:montanide ISA 51; D010844:Picibanil; D008353:Mannitol