A bivalent conjugate vaccine in the treatment of biochemically relapsed prostate cancer: A study of glycosylated MUC-2-KLH and Globo H-KLH conjugate vaccines given with the new semi-synthetic saponin immunological adjuvant GPI-0100 or QS-21 Journal Article


Authors: Slovin, S. F.; Ragupathi, G.; Fernandez, C.; Jefferson, M. P.; Diani, M.; Wilton, A. S.; Powell, S.; Spassova, M.; Reis, C.; Clausen, H.; Danishefsky, S.; Livingston, P.; Scher, H. I.
Article Title: A bivalent conjugate vaccine in the treatment of biochemically relapsed prostate cancer: A study of glycosylated MUC-2-KLH and Globo H-KLH conjugate vaccines given with the new semi-synthetic saponin immunological adjuvant GPI-0100 or QS-21
Abstract: GPI-0100 is a semi-synthetic saponin with modifications designed to augment stability and diminish toxicity. Two batches of GPI-0100 (the second with higher purity) were tested with doses ranging between 100 and 5000 μg in groups of five treated prostate cancer patients who had no evidence of disease except for rising PSA levels. GPI-0100 was mixed with a bivalent vaccine containing the glycolipid Globo H and the glycosylated mucin MUC2 conjugated to keyhole limpet hemocyanin (KLH). All doses were well tolerated and antibody titers against Globo H and MUC-2 escalated with the increasing dose levels. At the 5000 μg dose level in this patient population, toxicity remained minimal with only occasional grade II local toxicity at vaccination sites and occasional sporadic grade I elevations in ALT. Compared with a subsequent trial with the same bivalent vaccine plus QS-21 at the maximal tolerated dose of 100 μg, the 5000 μg dose of GPI-0100 produced comparable antibody titers. © 2005 Elsevier Ltd. All rights reserved.
Keywords: adult; clinical article; controlled study; aged; middle aged; unclassified drug; drug tolerability; fatigue; side effect; flow cytometry; prostate specific antigen; recurrence; chill; drug fever; flushing; injection site reaction; prostate cancer; pruritus; prostate-specific antigen; prostatic neoplasms; alanine aminotransferase; immunotherapy; cancer vaccine; cancer vaccines; psa; glycosylation; immunological adjuvant; flu like syndrome; headache; maximum tolerated dose; enzyme-linked immunosorbent assay; vaccine production; adjuvants, immunologic; drug dose regimen; drug conjugation; antibody titer; keyhole limpet hemocyanin; gpi 0100; saponins; vaccines, conjugate; mucin; glycolipid; qs 21; mucin 2; saponin; saponin derivative; immunization schedule; dose-response relationship, immunologic; globo h; gpi-0100; muc-2; qs21; capillary resistance; injection pain
Journal Title: Vaccine
Volume: 23
Issue: 24
ISSN: 0264-410X
Publisher: Elsevier Inc.  
Date Published: 2005-05-02
Start Page: 3114
End Page: 3122
Language: English
DOI: 10.1016/j.vaccine.2005.01.072
PUBMED: 15837210
PROVIDER: scopus
DOI/URL:
Notes: --- - "Cited By (since 1996): 32" - "Export Date: 24 October 2012" - "CODEN: VACCD" - "Source: Scopus"
Altmetric Score
MSK Authors
  1. Andrew Wilton
    27 Wilton
  2. Susan Slovin
    186 Slovin
  3. Govindaswami Ragupathi
    133 Ragupathi
  4. Howard Scher
    835 Scher
  5. Shemeeakah K Powell
    4 Powell
  6. Meghan Diani
    5 Diani