Granulocyte Colony Stimulating Factor Adjuvant Role on the Immunological Response to Hepatitis B Vaccine in Patients With Cirrhosis: A Double Blind Randomized Placebo Controlled Trial

BACKGROUND Patients with liver cirrhosis have usually poor antibody response to hepatitis B virus (HBV) vaccination. OBJECTIVES This study aimed to investigate the effect of granulocyte colony stimulating factor (G-CSF) on increasing antibody titers, after HBV vaccination, in patients with liver cirrhosis waiting for transplantation. PATIENTS AND METHODS From 56 patients with cirrhosis, 28 patients were allocated to receive double dose HBV vaccine (40 μgr) plus G-CSF and 28 patients were allocated to receive double dose HBV vaccine (40 μgr) plus placebo. Injections were performed on weeks 0, 4 and 8 and the blood samples were obtained one month after each vaccination session. RESULTS There was no statistically significant difference between anti-HBV antibody titers in patients receiving double dose HBV vaccination plus G-CSF and patients receiving double dose HBV vaccination plus placebo, after first, second or third vaccination rounds (P > 0.05). Although the adjuvant G-CSF injection did not cause significant increased antibody titers in our patients compared to the placebo group, the increase in antibody titers following vaccination, happened faster in this group, compared to the placebo group. CONCLUSIONS The present study showed that G-CSF is not superior to placebo in production of protective antibody titers after HBV vaccination but could result in a more rapid antibody response, compared to the placebo.