A pilot study on the combined therapy of granulocyte-macrophage colony-stimulating factor and hepatitis B vaccine on chronic hepatitis B virus carrier children.
- Author:
Jianshe WANG
1
;
Qirong ZHU
;
Ting ZHANG
;
Hui YU
Author Information
- Publication Type:Clinical Trial
- MeSH: Carrier State; therapy; Child; Child, Preschool; Combined Modality Therapy; DNA, Viral; blood; Granulocyte-Macrophage Colony-Stimulating Factor; therapeutic use; Hepatitis B Vaccines; immunology; Hepatitis B, Chronic; therapy; Humans; Immunoglobulins; therapeutic use; Pilot Projects; Vaccines, Synthetic; immunology
- From: Chinese Medical Journal 2002;115(12):1824-1828
- CountryChina
- Language:English
-
Abstract:
OBJECTIVETo 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).
METHODSA 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.
RESULTSTwelve 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.
CONCLUSIONCombined GM-CSF and rHBvac therapy inhibit HBV replication in carrier children who were not protected after treatment with immunoprophylaxis.