The purpose of this study is to investigate whether HB-Vac Activated-DCs Combined With Peg-IFN or NAs has more efficacy than Peg-IFN or NAs alone in the treatment of chronic hepatitis B patients
The 450 patients meeting the entry criteria are divided into 6 groups, the clinical trial procedure is divided into 3 parts, according to the following steps: Part1 (0-12W): 1. The research objects will be grouped according to the principle of a multicenter, randomized, open, parallel controlled clinical trial, 300 cases of cell therapy groups (100 cases with PEG-IFN treatment, LdT treatment for 100 cases, ETV treatment for 100 cases), 150 cases of control groups (PEG-IFN therapy in 50 cases, LdT therapy for 50 cases, ETV treatment for 50 cases). Part2 (12-36W): 2. Cell therapy groups: enter the HBsAg sensitized dendritic cells activated T cells (HBsAg Pulse DCs-T, HPDCs-T) immune therapy combined with interferon (IFN) or nucleoside analogues treatment (NAs), infusion of HPDC-T every 2 weeks for 1 time, total 12 times. 3. Control groups: antiviral therapy used only (IFN or NAs). Part3 (36-72W): 4. The observation stage: discontinuation of interferon in the treatment of 48 weeks; NAs cases will continue on treatment with NAs. HPDCs-T produced procedure: The first step: 1-7 days Monocytes will be isolated from peripheral blood of patients. The monocytes obtained will be then incubated in fresh serum-free AIM-V medium (Gibco) containing 800U/ml of GM-CSF and 400U/ml of IL-4 (Peprotech) for 5 days. After 5 days of culture in vitro, The DCs induced will be cultured with a commercially available hepatitis B vaccine containing 10 ug of HBsAg (GSK) for 2 days. The second step: 8-14 days The hepatitis B vaccine sensitized DCs (HPDCs) (from the first step) will be sub-cultured with patient's own PBMCs for 7 days: HBsAg can be efficiently presented to PBMCs by DCs, with producing HBV specific CTLs and HTLs (HPDCs-T). The third step: 15 days The PBMCs (the second step) containing enough HPDCs-T will be transfused back into the patient.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
HPDCs-T immune therapy:one time every 2 weeks during 12 weeks to 36 weeks, IV (in the vein), about 2\*105-1\*106 cells per time,total 12 times;
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
The second people's hospital of yunnan province
Kunming, Yunnan, China
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, China
HBV makers
HBV DNA loads,HBsAg/HBsAb titer,HBeAg/HBeAb titer
Time frame: 01/01/2014-31/12/2016, total 6 times (3 years)
Coagulation tests
PT,PTA,INR
Time frame: 01/01/2014-31/12/2016, total 6 times (3 years)
liver function
ALT,AST,Tbil,Alb
Time frame: 01/01/2014-31/12/2016, total 6 times (3 years)
alpha-fetal protein
AFP;Biomarkers of hepatocellular carcinoma,one time every 24 weeks
Time frame: 01/01/2014-31/12/2016, total 4 times (3 years)
B ultrasound or MRI examination of the liver
The examination is performed both at the end of the pre-experiment and the main experiment
Time frame: 01/01/2014-31/12/2016, total 2 times (3 years)
Liver biopsy
The examination is performed both before and during experiment.
Time frame: 01/01/2014-31/12/2016, total 2 times (3 years)
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