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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.

AbstractOBJECTIVES: 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.
AuthorsMünci Yağci, Kadir Acar, Gülsan Türköz Sucak, Kadri Yamaç, Rauf Haznedar (Affiliation: Department of Hematology, Gazi University, Ankara, Turkey. ayagci at gazi.edu.tr)
JournalEuropean journal of haematology (Eur J Haematol) Vol. 79 Issue 4 Pg. 292-6 (Oct 2007) ISSN: 0902-4441 Denmark
PMID17655695 (Publication Type: Journal Article, Randomized Controlled Trial)
Chemical References
  • Adjuvants, Immunologic
  • Hepatitis B Antibodies
  • Hepatitis B Vaccines
  • Vaccines, Synthetic
  • Granulocyte-Macrophage Colony-Stimulating Factor
Topics
  • Adjuvants, Immunologic (administration & dosage)
  • Adolescent
  • Adult
  • Age Factors
  • Aged
  • Aged, 80 and over
  • Antibody Formation (drug effects, immunology)
  • Dose-Response Relationship, Immunologic
  • Female
  • Granulocyte-Macrophage Colony-Stimulating Factor (administration & dosage, immunology)
  • Hematologic Neoplasms (blood, complications, immunology)
  • Hepatitis B (etiology, immunology, prevention & control)
  • Hepatitis B Antibodies (blood, immunology)
  • Hepatitis B Vaccines (administration & dosage, immunology)
  • Humans
  • Immunocompromised Host (drug effects, immunology)
  • Lymphoproliferative Disorders (blood, complications, immunology)
  • Male
  • Middle Aged
  • Prospective Studies
  • Risk Factors
  • Time Factors
  • Vaccines, Synthetic (administration & dosage, immunology)