A multipeptide vaccine is safe and elicits T-cell responses in participants with advanced stage ovarian cancer

J Immunother. 2008 May;31(4):420-30. doi: 10.1097/CJI.0b013e31816dad10.

Abstract

Nine participants with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, who were human leukocyte antigen (HLA)-A1, HLA-A2, or HLA-A3, were eligible to enroll in a phase 1 study designed to assess the safety and immunogenicity of a peptide-based vaccine. Participants received 5 class I major histocompatibility complex-restricted synthetic peptides derived from multiple ovarian cancer-associated proteins plus a class II major histocompatibility complex-restricted synthetic helper peptide derived from tetanus toxoid protein. The vaccines were administered with granulocyte macrophage-colony stimulating factor in Montanide ISA-51 adjuvant over a 7-week period. All vaccine-related toxicities were grade 1 to 2, the most common being injection site reaction (grade 2, 100%), fatigue (grade 1, 78%), and headache (grade 1, 67%). Lymphocytes from the peripheral blood and a node draining a secondary vaccine site (sentinel immunized node) were harvested during the course of vaccination and T-cell responses to the peptides were evaluated using an enzyme-linked immunosorbent spot assay. CD8 T-cell responses were detected in 1 participant ex vivo and in 8 of 9 participants (89%) after in vitro stimulation. All 4 HLA-A2 and HLA-A3-restricted peptides were immunogenic. This includes 2 peptides, folate binding protein (FBP191-199) and Her-2/neu754-762, which had not previously been evaluated in vaccines in humans. Responding T cells required over 200 nM for half-maximal reactivity. These data support continued investigation of these peptides as immunogens for patients with ovarian cancer but, owing to low potency, also suggest a need for additional immunomodulation in combination with vaccines to increase the magnitude and to improve the quality of the T-cell responses.

Publication types

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

MeSH terms

  • Antigens, Neoplasm / administration & dosage
  • Antigens, Neoplasm / immunology
  • Cancer Vaccines* / administration & dosage
  • Cancer Vaccines* / adverse effects
  • DNA Helicases / administration & dosage
  • DNA-Binding Proteins / administration & dosage
  • Dose-Response Relationship, Immunologic
  • Female
  • Humans
  • Immunodominant Epitopes / administration & dosage
  • Immunodominant Epitopes / immunology
  • Interferon-gamma / immunology
  • Interferon-gamma / metabolism
  • Mannitol / administration & dosage
  • Mannitol / adverse effects
  • Mannitol / analogs & derivatives
  • Melanoma-Specific Antigens
  • Neoplasm Proteins / administration & dosage
  • Neoplasm Proteins / immunology
  • Neoplasm Staging
  • Neoplasms, Glandular and Epithelial / immunology
  • Neoplasms, Glandular and Epithelial / pathology
  • Neoplasms, Glandular and Epithelial / therapy*
  • Oleic Acids / administration & dosage
  • Oleic Acids / adverse effects
  • Ovarian Neoplasms / immunology
  • Ovarian Neoplasms / pathology
  • Ovarian Neoplasms / therapy*
  • Peptide Fragments / administration & dosage
  • Peptide Fragments / immunology
  • Peritoneal Neoplasms / immunology
  • Peritoneal Neoplasms / pathology
  • Peritoneal Neoplasms / therapy*
  • RNA-Binding Proteins
  • T-Lymphocytes / immunology*
  • T-Lymphocytes / metabolism
  • Treatment Outcome
  • Vaccination* / adverse effects
  • Vaccines, Subunit / administration & dosage
  • Vaccines, Subunit / adverse effects

Substances

  • Antigens, Neoplasm
  • Cancer Vaccines
  • DNA-Binding Proteins
  • FUBP1 protein, human
  • HER-2 peptide E75 (369-377), human
  • Immunodominant Epitopes
  • Melanoma-Specific Antigens
  • Neoplasm Proteins
  • Oleic Acids
  • Peptide Fragments
  • RNA-Binding Proteins
  • Vaccines, Subunit
  • montanide ISA 51
  • Mannitol
  • Interferon-gamma
  • DNA Helicases