Immunization of colorectal cancer patients with recombinant baculovirus-derived KSA (Ep-CAM) formulated with monophosphoryl lipid A in liposomal emulsion, with and without granulocyte-macrophage colony-stimulating factor

Vaccine. 2004 Jan 26;22(5-6):773-80. doi: 10.1016/j.vaccine.2003.08.021.


KSA (Ep-CAM) is highly expressed by colorectal cancers. The safety and immunologic effects of a vaccine consisting of recombinant baculovirus-derived KSA formulated with monophosphoryl lipid A (MPL) in liposomes and emulsified in mineral oil were evaluated, with and without co-administration of granulocyte-macrophage colony-stimulating factor (GM-CSF). Eleven patients with metastatic colorectal cancer received three subcutaneous (s.c.) injections of the vaccine at 4-week intervals. Six patients were randomized to also receive human recombinant GM-CSF (rGM-CSF) by subcutaneous injection daily for 4 days with each vaccination. Immunizations with and without rGM-CSF were well tolerated. Seven of the 11 patients developed significant KSA-specific cellular immune responses as assessed by lymphoproliferation and interferon-gamma (IFN-gamma) ELISPOT assays. All nine tested patients developed positive delayed type hypersensitivity reactions. Eight of the 11 patients developed KSA-specific antibody responses. The highest levels of cellular immune responses were observed in patients who received GM-CSF. Immunization with baculovirus-derived KSA formulated with monophosphoryl lipid A in liposomal emulsion is safe and can elicit KSA-specific immune responses. Co-administration of GM-CSF with this formulation is an effective method of generating KSA-specific T-helper (Th) 1-associated cellular immune responses.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Adjuvants, Immunologic / pharmacology*
  • Adult
  • Aged
  • Antibodies, Neoplasm / analysis
  • Antibodies, Neoplasm / biosynthesis
  • Antibody Formation / immunology
  • Antigen-Antibody Reactions
  • Antigens, Neoplasm / immunology*
  • Baculoviridae / immunology*
  • Cancer Vaccines / adverse effects
  • Cancer Vaccines / immunology*
  • Cell Adhesion Molecules / immunology*
  • Cell Division
  • Chemistry, Pharmaceutical
  • Colorectal Neoplasms / immunology*
  • Emulsions
  • Enzyme-Linked Immunosorbent Assay
  • Epithelial Cell Adhesion Molecule
  • Escherichia coli / immunology
  • Female
  • Granulocyte Colony-Stimulating Factor / pharmacology*
  • Humans
  • Immunity, Cellular / immunology
  • Immunization
  • Interferon-gamma / biosynthesis
  • Lipid A / chemistry*
  • Liposomes
  • Lymphocyte Count
  • Male
  • Middle Aged
  • Mineral Oil
  • Pilot Projects
  • Recombinant Proteins
  • Skin Tests
  • Vaccines, Synthetic / immunology


  • Adjuvants, Immunologic
  • Antibodies, Neoplasm
  • Antigens, Neoplasm
  • Cancer Vaccines
  • Cell Adhesion Molecules
  • Emulsions
  • Epithelial Cell Adhesion Molecule
  • Lipid A
  • Liposomes
  • Recombinant Proteins
  • Vaccines, Synthetic
  • Granulocyte Colony-Stimulating Factor
  • Mineral Oil
  • Interferon-gamma