ABSTRACT
Background: chronic dialysis patients often fail to produce protective antibodies to hepatitis B virus surface antigen after vaccination towards hepatitis B virus [HBV]. The aim of this study was to evaluate efficacy and safety of GM-CSF as adjuvant to hepatitis B vaccine in patients with ESRD
Materials and Methods: 41 consecutive patients with chronic renal failure [CRF], commenced on dialysis, were stratified to receive either 40 mg HBV vaccine at 0, 1, 2 and 6 months [group A, n = 19] or 3 mg kg-1 GM-CSF on day 1 followed by the vaccination schedule described above [group B, n = 22]. All patients were negative for Hepatitis B surface antigen [HBsAg], antibodies to hepatitis C virus [anti-HCV] and human immunodeficiency virus [HIV] serology. Titres of antibody to HBsAg [HBsAb] were quantitatively assayed, using enzyme-linked immunosorbent assay [ELISA], at 1, and 7 months from the first dose of vaccination
Results: only 42.1% of the patients in group A developed protective antibody levels [mean HBsAb: 24.8 IU l-1] after first month and 63.2% of responders developed protective antibody levels [HBsAb >10 IU l-1] only after the senventh dose of vaccination. In contrast, 72.7% of patients in group B developed protective levels of HBsAb at the end of first month [mean HBsAb: 41.8 IU l-1] [P < 0.05]. 72.7% of the responders were protected after third dose of vaccination [P = 0.374]. No serious adverse effects of GM-CSF were observed in group B
Conclusion: our study showed improved seroprotection rates with HBV vaccine after GM-CSF administration