Chronic Hepatitis B Clinical Trial
Official title:
A Clinical Trial on Hepatitis B Vaccine Activated-Dendritic Cells Combined With Anti-HBV Drugs in Chronic Hepatitis B
The anti-virus effects is not satisfying in some of Chronic Hepatitis B（CHB) patients who have been on anti-Hepatitis B Virus (HBV) drugs therapy. Dendritic cell (DC) is critical in Hepatitis B Virus (HBV) specific immunity in the process of producing HBV promoter specific cytotoxic T cells (CTLs) and specific T helper cells (HTLs), however they are defective in CHB patients. Therefore, if it were going to remove HBV completely, it mainly depends if the body itself can produce enough HBV specific cytotoxic T cells (CTLs) and specific T helper cells (HTLs). Our research is to plus Hepatitis B Vaccine Activated-DCs therapy to CHB patients who have been on anti-HBV drugs but with poor effects, supposing to significantly improve anti-HBV efficacy, even to clean HBV from the patients.
Patients who have been on anti-HBV therapy Complying with the inclusion criteria will be
enrolled into our research, Nucleoside analogues (NAs,entecavir） treatment for more than 1
year or interferon（IFN)-a-2a (IFN-a-2a,Pegasys） treatment for more than 24 weeks. The
patients will be randomly assigned to experimental group and control group with the ratio of
2:1, one group (control group) will go on receive the anti-HBV drugs treatment solely;
another group (experimental group) after enrollment will immediately receive the Hepatitis B
Vaccine activated-DCs (HPDC-T cells) for 24 weeks (every 2 weeks once for 24 weeks, 12 times
in total), at the same time co-use anti-HBV drugs treatment, as for Pegasys, it will go on
to be used for 12 weeks after HPDC-T cells treatment completed.
The technical route of HBV-T cells prepared: First, investigators collect fresh blood of
CHB, mononuclear cells were isolated, and induced to HBsAg pulsed DCs in Hepatitis B vaccine
(Shenzhen kangtai, Shenzhen, China) and interleukin-4（IL-4)/granulocyte-macrophage
colony-stimulating factor(GM-CSF） (Perprotech, New Jersey, USA) (7 days), then co-culture of
DCs and Peripheral Blood Mononuclear Cell(PBMCs ）7days, obtain HBV specific T cells, return
to the patient finally.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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