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


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.


CONCLUSIONS
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.
Yağci
Münci
M
Department of Hematology, Gazi University, Ankara, Turkey. ayagci@gazi.edu.tr
Acar
Kadir
K
Sucak
Gülsan Türköz
GT
Yamaç
Kadri
K
Haznedar
Rauf
R
D000276:Adjuvants, Immunologic / Q000008:administration & dosage*; D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000917:Antibody Formation / Q000187:drug effects / Q000276:immunology; D004306:Dose-Response Relationship, Immunologic; D005260:Female; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000008:administration & dosage* / Q000276:immunology; D019337:Hematologic Neoplasms / Q000097:blood / Q000150:complications / Q000276:immunology*; D006509:Hepatitis B / Q000209:etiology / Q000276:immunology / Q000517:prevention & control; D006510:Hepatitis B Antibodies / Q000097:blood / Q000276:immunology*; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000276:immunology; D006801:Humans; D016867:Immunocompromised Host / Q000187:drug effects / Q000276:immunology; D008232:Lymphoproliferative Disorders / Q000097:blood / Q000150:complications / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012307:Risk Factors; D013997:Time Factors; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000276:immunology
D000276:Adjuvants, Immunologic; D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines; D014614:Vaccines, Synthetic; D016178:Granulocyte-Macrophage Colony-Stimulating Factor