title: Granulocyte macrophage colony stimulating factor (GM-CSF) induced sero-protection in end stage renal failure patients to hepatitis B in vaccine non-responders.
abstract: Hepatitis B (HB) virus infection is a major health problem in dialysis dependent end stage renal failure (ESRF) patients. The sero-conversion rate after recombinant HB vaccine in ESRF patients is poor. Adjuvants like Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF) have been found to improve response rate to vaccines. This study was conducted to evaluate the efficacy of GM-CSF as an adjuvant to HB vaccine in ESRF patients who were non-responders to the usual three double dose vaccinations (primary non-responders). Fifty consecutive HBsAg negative and anti-HBs negative ESRF patients on hemodialysis over thirty months were prospectively included (Jan. 96-June 98). All received 40 microg of recombinant HB vaccine at 0, 1, 2 month interval. Anti-HBs titres were subsequently tested after four weeks of the third dose. There were 19 (38%) primary non-responders (antiHBs negative). Twelve (Group I) of primary non-responders were given an additional dose of HB vaccine with 300 microg (5-6 microg/kg) of GM-CSF (Leucomax) and the remaining seven (Group II) received only an additional dose of HB vaccine. Anti-HBs was determined by Abbott's ELISA kit, and titre above 10 mIU/mL was considered as protective. In Group I, sero-protective titres were obtained in 11 out of 12 (91.6%) patients, whereas in Group II none of the patients achieved sero-protection (p < 0.001). The sero-conversion rate improved from initial 62% (31/50) to overall 84% (42/150) after the use of GM-CSF. There were no adverse events noted with the use of GM-CSF. At one year, 24 out of 32 (75%) who were sero-protected earlier continued to remain sero-protected. This study indicates that GM-CSF is a potent HB vaccine adjuvant for sero-conversion in primary non-responders.
authors.affiliation: Department of Nephrology, Medwin Hospitals, Hyderabad, Andhra Pradesh, India. ratanjha@nettlinx.com
authors.forename: R
authors.initials: R
authors.lastname: Jha
authors.forename: S
authors.initials: S
authors.lastname: Lakhtakia
authors.forename: M A
authors.initials: MA
authors.lastname: Jaleel
authors.forename: G
authors.initials: G
authors.lastname: Narayan
authors.forename: K
authors.initials: K
authors.lastname: Hemlatha
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage*; D000328:Adult; D016009:Chi-Square Distribution; D003131:Combined Modality Therapy; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000008:administration & dosage*; D006509:Hepatitis B / Q000188:drug therapy* / Q000276:immunology / Q000517:prevention & control*; D006510:Hepatitis B Antibodies / Q000097:blood; D017325:Hepatitis B Vaccines / Q000008:administration & dosage*; D006801:Humans; D007194:India; D007676:Kidney Failure, Chronic / Q000175:diagnosis / Q000628:therapy; D008297:Male; D008875:Middle Aged; D011336:Probability; D011446:Prospective Studies; D006435:Renal Dialysis; D018570:Risk Assessment; D016896:Treatment Outcome
chemical_list: D000276:Adjuvants, Immunologic; D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines; D016178:Granulocyte-Macrophage Colony-Stimulating Factor