Immunization of ovarian cancer patients with a synthetic Lewis(y)-protein conjugate vaccine: a phase 1 trial

Int J Cancer. 2000 Jul 1;87(1):79-85.


As the initial step in developing carbohydrate-based vaccines for the treatment of ovarian cancer patients in an adjuvant setting, 25 patients were immunized with a Lewis(y) pentasaccharide (Le(y))-keyhole limpet hemocyanin (KLH)-conjugate vaccine together with the immunological adjuvant QS-21. Four different doses of the vaccine, containing 3, 10, 30, and 60 microg of carbohydrate were administered s.c. at 0, 1, 2, 3, 7, and 19 weeks to groups of 6 patients. Sera taken from the patients at regular intervals were assayed by ELISA for reactivity with naturally occurring forms of Le(y) (Le(y)-ceramide and Le(y) mucin) and by flow cytometry and a complement-dependent cytoxicity assay for reactivity with Le(y)-expressing tumor cells. The majority of the patients (16/24) produced anti-Le(y) antibodies as assessed by ELISA, and a proportion of these had strong anti-tumor cell reactivity as assessed by flow cytometry and complement-dependent cytotoxicity. One serum, analyzed in detail, was shown to react with glycolipids but not with glycoproteins or mucins expressed by ovarian cancer cell line OVCAR-3. The vaccine was well tolerated and no gastrointestinal, hematologic, renal, or hepatic toxicity related to the vaccine was observed. On the basis of this study, Le(y)-KLH should be a suitable component for a polyvalent vaccine under consideration for the therapy of epithelial cancers.

Publication types

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

MeSH terms

  • Adjuvants, Immunologic
  • Adult
  • Aged
  • Cancer Vaccines*
  • Carbohydrate Sequence
  • Carcinoma, Endometrioid / immunology
  • Carcinoma, Endometrioid / therapy
  • Chromatography, Thin Layer
  • Cystadenocarcinoma, Papillary / immunology
  • Cystadenocarcinoma, Papillary / therapy
  • Enzyme-Linked Immunosorbent Assay
  • Female
  • Flow Cytometry
  • Hemocyanins / therapeutic use
  • Humans
  • Lewis Blood Group Antigens / therapeutic use*
  • Middle Aged
  • Molecular Sequence Data
  • Ovarian Neoplasms / immunology*
  • Ovarian Neoplasms / therapy*
  • Saponins / therapeutic use
  • Time Factors
  • Treatment Outcome
  • Tumor Cells, Cultured
  • Vaccines, Conjugate*


  • Adjuvants, Immunologic
  • Cancer Vaccines
  • Lewis Blood Group Antigens
  • Lewis Y antigen
  • Saponins
  • Vaccines, Conjugate
  • saponin QA-21V1
  • Hemocyanins
  • keyhole-limpet hemocyanin