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Granulocyte–macrophage colony‐stimulating factor enhances the efficacy of hepatitis B virus vaccine in previously unvaccinated haemodialysis patients

The response to vaccination with recombinant hepatitis B virus (HBV) vaccine is poor in haemodialysis patients. A defect in the antigen‐presenting cells may be responsible for this hyporesponsiveness. To overcome this and to improve the response to HBV vaccine in dialysis patients, we used granulocyte–macrophage colony‐stimulating factor (GM‐CSF) as a vaccine adjuvant. Fifteen consecutive patients with chronic renal failure (CRF), commenced on dialysis, were stratified to receive either 40μg HBV vaccine (Engerix‐B) at 0, 1, 2 and 6 months (group A, n=9) or 3μg kg–1 GM‐CSF (Leucomax) on day 1 followed by the vaccination schedule described above (group B, n=6). 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, 2, 6 and 7 months from the first dose of vaccination. Only 44% of the patients in group A developed protective antibody levels (mean HBsAb: 22 IU l–1) Fifty per cent of responders developed protective antibody levels (HBsAb >10 IU l–1) only after the fourth dose of vaccination. In contrast, all six patients (100%) in group B developed protective levels of HBsAb (mean HBsAb: 70 IU l–1) (P<0.02). Sixty‐seven per cent of the responders were protected after only the second dose of vaccination (P=0.046). No serious adverse effects of GM‐CSF were observed in group B. Hence, haemodialysis patients respond poorly to HBV vaccine. GM‐CSF is a safe vaccine adjuvant capable of stimulating an earlier and a stronger antibody response to HBV vaccine in haemodialysis patients.