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) vaccin e is poor in haemodialysis patients. A defect in the antigen-presenting cel ls may be responsible for this hyporesponsiveness, To overcome this and to improve the response to HBV vaccine in dialysis patients, we used granulocy te-macrophage colony-stimulating factor (GM-CSF) as a vaccine adjuvant, Fif teen consecutive patients with chronic renal failure (CRF), commenced on di alysis, were stratified to receive either 40 mu g HBV vaccine (Engerix-B) a t 0, 1, 2 and 6 months (group A, n = 9) or 3 mu g 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 anti gen (HBsAg), a ntibodies to hepatitis C virus (anti-HCV) and human immunodeficiency virus (HIV) serology. Titres of antibody to HBsAg (HBsAb) were quantitatively ass ayed, using enzyme-linked immunosorbent assay (ELISA), at 1, 2, 6 and 7 mon ths 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 c ent 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 afte r only the second dose of vaccination (P = 0.046). No serious adverse effec ts of GM-CSF were observed in group B. Hence, haemodialysis patients respon d poorly to HBV vaccine. GM-CSF is a safe vaccine adjuvant capable of stimu lating an earlier and a stronger antibody response to HBV vaccine in haemod ialysis patients.