The safety and efficacy of GM-CSF as an adjuvant in hepatitis B vaccination of chronic hemodialysis patients who have failed primary vaccination

T. G. Evans, M. Schiff, B. Graves, J. Agosti, M. L. Barritt, D. Garner, J. L. Holley

Research output: Contribution to journalArticlepeer-review

Abstract

Background: End-stage renal disease and the need for chronic hemodialysis is an indication for hepatitis B vaccination, but up to half of dialysis patients fail to respond to a 40 μg/dose i.m. three-dose primary series of recombinant hepatitis B vaccine. Only another 10 - 20% respond to additional boosting doses of vaccine. Patients and methods: Since GM-CSF has been shown to be an effective adjuvant for hepatitis B vaccine in healthy subjects and multiple animal vaccine models, we conducted a randomized, double-blind trial of GM-CSF with recombinant hepatitis B vaccine in chronic hemodialysis patients. Patients with negative hepatitis B surface antibody and antigen who had received at least three doses of recombinant hepatitis B vaccine without response (antibody titre < 10 mIU/ml) were randomized to placebo, 40 μg, or 80 μg of GM-CSF given with 40 μg recombinant hepatitis B vaccine i.m. at the same site. Clinical and laboratory studies for safety assessment were done on days 1 and 3, and hepatitis B surface antibody titres were measured at baseline and days 21 and 180 after the study injections. Results: No significant local or systemic toxicity was noted from the co-injections. The rates of response and geometric mean titre (GMT) were equivalent among all three study groups: placebo 6/10 developed antibodies, GMT 22.1 mIU/ml; 40 μg GM-CSF 3/10 developed antibodies, GMT 5.4 mIU; and 80 μg GM-CSF 3/8 developed antibodies, GMT 9.7 mIU/ml. Six months after vaccination, antibody titres were available for 11 of the 12 day 21 positive responders; only 4 of these 11 patients remained antibody positive at 6 months. Conclusion: GM-CSF given in a single 40 μg and 80 μg i.m. dose was not an effective adjuvant with hepatitis B vaccine in chronic hemodialysis patients who had previously failed to respond to hepatitis B immunization.

Original languageEnglish (US)
Pages (from-to)138-142
Number of pages5
JournalClinical Nephrology
Volume54
Issue number2
StatePublished - 2000
Externally publishedYes

Keywords

  • Dialysis
  • End-stage renal disease
  • Hepatitis B
  • Vaccination

ASJC Scopus subject areas

  • Nephrology

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