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Hepatitis B virus vaccine in lymphoproliferative disorders: a prospective randomized study evaluating the efficacy of granulocyte‐macrophage colony stimulating factor as a vaccine adjuvant
Author(s) -
Yağcı Münci,
Acar Kadir,
Sucak Gülsan Türköz,
Yamaç Kadri,
Haznedar Rauf
Publication year - 2007
Publication title -
european journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.904
H-Index - 84
eISSN - 1600-0609
pISSN - 0902-4441
DOI - 10.1111/j.1600-0609.2007.00912.x
Subject(s) - medicine , hepatitis b virus , immunology , antibody titer , hepatitis b vaccine , adjuvant , gastroenterology , hepatitis b , vaccination , titer , antibody , virus , hbsag
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 μg HBV vac intramuscularly or one course of 40 μg HBV vac 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 + 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 μg 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.