title: A pilot study on the combined therapy of granulocyte-macrophage colony-stimulating factor and hepatitis B vaccine on chronic hepatitis B virus carrier children.
abstract: OBJECTIVE
  To observe the efficacy of treating intrauterine infected chronic hepatitis B virus (HBV) carrier children with a combination of granulocyte-macrophage colony-stimulating factor (GM-CSF) or hepatitis B immunoglobulin (HBIG) plus recombinant hepatitis B vaccine (rHBvac).
  
  
  METHODS
  A total of 27 chronic HBV infected children, who were born to HBV carrier mothers and received hepatitis B immunoprophylaxis at birth, were randomized into 2 groups: one receiving a combined therapy of 50 micro g of GM-CSF plus 10 micro g of rHBvac injected intramuscularly at the same location (GM-CSF group, 14 children) or 200 IU HBIG and 10 micro g rHBvac in different muscles (HBIG group, 13 children) on a monthly four-dose schedule. HBV-DNA quantification and other HBV serological markers were tested before and after the four-dose therapy.
  
  
  RESULTS
  Twelve children in each group completed the study. Of them, 3 children in the GM-CSF group and 4 in the HBIG group had elevated serum alanine transaminase (ALT) before the trial, and then 2 in each group became ALT normal after the treatment. Before the therapy, hepatitis B e antigen (HBeAg) positivity was found in nine children in the GM-CSF group and 10 in the HBIG group. One from each group had an HBeAg/anti-HBe seroconversion after the treatment. The quantity of HBV-DNA was significantly lower after the treatment (P = 0.023) in GM-CSF group, but was not significantly reduced in HBIG group. No subjects were found to be negative for hepatitis B surface antigen (HBsAg) after the treatment, and no serious adverse events occurred in either group.
  
  
  CONCLUSIONS
  Combined GM-CSF and rHBvac therapy inhibit HBV replication in carrier children who were not protected after treatment with immunoprophylaxis.
authors.affiliation: Department of Infectious Disease, Children's Hospital, Fudan University, Shanghai 200032, China. jianshewang@sina.com
authors.forename: Jianshe
authors.initials: J
authors.lastname: Wang
authors.forename: Qirong
authors.initials: Q
authors.lastname: Zhu
authors.forename: Ting
authors.initials: T
authors.lastname: Zhang
authors.forename: Hui
authors.initials: H
authors.lastname: Yu
mesh_terms: D002353:Carrier State / Q000628:therapy*; D002648:Child; D002675:Child, Preschool; D003131:Combined Modality Therapy; D004279:DNA, Viral / Q000097:blood; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000627:therapeutic use*; D017325:Hepatitis B Vaccines / Q000276:immunology*; D019694:Hepatitis B, Chronic / Q000628:therapy*; D006801:Humans; D007136:Immunoglobulins / Q000627:therapeutic use*; D010865:Pilot Projects; D014614:Vaccines, Synthetic / Q000276:immunology*
chemical_list: D004279:DNA, Viral; D017325:Hepatitis B Vaccines; D007136:Immunoglobulins; D014614:Vaccines, Synthetic; D016178:Granulocyte-Macrophage Colony-Stimulating Factor; C045213:hepatitis B hyperimmune globulin