OBJECTIVES: Hepatitis B virus (HBV) infection is effectively preventable by immunization with the commercially available recombinant HBV vaccines (HBV(vac)) in approximately 95% of healthy people. Immunosuppressive diseases like hematological malignancies are a risk factor for non-response to HBV(vac). The aim of this study was to determine the efficacy and safety of granulocyte-macrophage colony-stimulating factor (GM-CSF) as a vaccine adjuvant in lymphoproliferative disorders (LPD). PATIENTS AND METHODS: One- hundred and two patients with LPD were randomized to receive either a single dose of 40 mug HBV(vac) intramuscularly or one course of 40 mug HBV(vac) after 5 mug/kg recombinant GM-CSF injection. RESULTS: Of the 94 patients that could be evaluated at 1 month, the seroprotection rate was higher in GM-CSF + HBV(vac) group (25.5% in GM-CSF + HBV(vac) group vs. 17% in HBV(vac) group). The median anti-HBs titer was also higher in GM-CSF + HBV(vac) group. However the difference did not reach to a significant level in terms of response rate and median antibody titers (P > 0.05). Univariate analysis identified age and time to vaccination from the last chemotherapy course as significant predictors of seroprotection. In multivariate analysis, age was the only predictor of achieving a seroprotective response. Patients who lost the seroprotective response during monitoring were boosted with a 20 microg HBV(vac) and they all achieved a seroprotective anti-HBs titer > 100 mIU/mL. CONCLUSION: In LPD, the response to HBV(vac) is impaired. GM-CSF enhance to HBV(vac) in terms of the rate of response and average of antibody titers at the dose and schedule given.
RCT Entities:
OBJECTIVES:Hepatitis B virus (HBV) infection is effectively preventable by immunization with the commercially available recombinant HBV vaccines (HBV(vac)) in approximately 95% of healthy people. Immunosuppressive diseases like hematological malignancies are a risk factor for non-response to HBV(vac). The aim of this study was to determine the efficacy and safety of granulocyte-macrophage colony-stimulating factor (GM-CSF) as a vaccine adjuvant in lymphoproliferative disorders (LPD). PATIENTS AND METHODS: One- hundred and two patients with LPD were randomized to receive either a single dose of 40 mug HBV(vac) intramuscularly or one course of 40 mug HBV(vac) after 5 mug/kg recombinant GM-CSF injection. RESULTS: Of the 94 patients that could be evaluated at 1 month, the seroprotection rate was higher in GM-CSF + HBV(vac) group (25.5% in GM-CSF + HBV(vac) group vs. 17% in HBV(vac) group). The median anti-HBs titer was also higher in GM-CSF + HBV(vac) group. However the difference did not reach to a significant level in terms of response rate and median antibody titers (P > 0.05). Univariate analysis identified age and time to vaccination from the last chemotherapy course as significant predictors of seroprotection. In multivariate analysis, age was the only predictor of achieving a seroprotective response. Patients who lost the seroprotective response during monitoring were boosted with a 20 microg HBV(vac) and they all achieved a seroprotective anti-HBs titer > 100 mIU/mL. CONCLUSION: In LPD, the response to HBV(vac) is impaired. GM-CSF enhance to HBV(vac) in terms of the rate of response and average of antibody titers at the dose and schedule given.