Hepatitis B virus vaccine in lymphoproliferative disorders: a prospective randomized study evaluating the efficacy of granulocyte‐macrophage colony stimulating factor as a vaccine adjuvant

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Abstract
Objectives:  Hepatitis B virus (HBV) infection is effectively preventable by immunization with the commercially available recombinant HBV vaccines (HBVvac) in approximately 95% of healthy people. Immunosuppressive diseases like hematological malignancies are a risk factor for non‐response to HBVvac. 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 μg HBVvac intramuscularly or one course of 40 μg HBVvac after 5 μg/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 + HBVvac group (25.5% in GM‐CSF + HBVvac group vs. 17% in HBVvac group). The median anti‐HBs titer was also higher in GM‐CSF + HBVvac 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 μg HBVvac and they all achieved a seroprotective anti‐HBs titer > 100 mIU/mL.Conclusion:  In LPD, the response to HBVvac is impaired. GM‐CSF enhance to HBVvac in terms of the rate of response and average of antibody titers at the dose and schedule given.

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