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Clinical study of anti-HBV-DC vaccine combine Drugs treat the HBeAg positive chronic hepatitis B Patients
发布时间: 2013-06-20    人气指数:1083

APASL 2013---The 23th Conference of the Asian Pacific Association for the Study of the Liver

Poster Presentation(Abstract NO 744)

Hepatology International. 2013, 7(Suppl 1):s202.


Bang-Fu Wu1,2, Jiang-Ying Yang2, Ya-Lin Zhang3, Yong Liu1, Hui-Hua Zhou3, Xuan-Qin Wang1, Fang-Qin Li1, Chun-Qiong Hou3, Xue-Song Li1, Xiang-Hua Huang1, Zheng-Sheng Xiao1, Ming Yang1, Fu-Xin Lin3, Yan-Ping Fu3, Shuo Zheng3, Wei Chen3, Yun Zhou2, Jun Yang2, Xin-He Wan1, Hui Huang1

1.Gastroenterology and Hepatology Center, Southern Medical University Renkang Hospital, Houjie Dongxi Road, No.88, Dongguan 523952, China

2 Guangzhou Pubang Bio-Immunological Tech Research Institute, Kezhu Road, No.232-2, Room 205, Guangzhou Science City, Luogang District, Guangzhou 510663, China

3 Gastroenterology and Hepatology Center, Tongji Medical College Affiliated Dongguan Hospital, Huazhong University of Science and Technology, Liaobu Southwest Road, No.171-175, Dongguan 523416, China



Background/Aims: To observe the clinical efficacy of anti-HBV-DC vaccine, the dendritic cells originating from peripheral blood mononuclear cells(PBMC) sensitized by HBsAg, in combination with lamivudine and thymosin-α1, in HBeAg positive chronic hepatitis B(CHB) patients.
Methods: 36 patients were recruited in the trial including 18 with ALT≤2ULN and 18 with ALT>2ULN. PBMCs obtained from 50ml of heparinized peripheral blood through density gradient centrifuge and adherence method were proliferated under the induction by GM-CSF and IL-4, and sensitized with the stock of hepatitis B vaccine containing 30µg HBsAg on day 5 and with hepatitis B vaccine commercially available containing 20µg HBsAg on day 6. anti-HBV-DC vaccine was harvested on day 7 and injected, half hypodermically and half intravenously, to the patient once every two weeks for 12 practices applications totally. Lamivudine was taken 100mg daily, and thymosin-α1 1.6mg was injected hypodermically twice a week. HBVM(TRFIA) and HBVDNA and ALT were evaluated at week 0, 4, 12, and 24.
Results: Mean of HBsAg, HBeAg, HBVDNA and ATL decreased significantly, while mean of HBeAb increased obviously after therapy of 4, 12 and 24 weeks. At week 4, 12 and 24, HBeAg negative conversion rate were 44.44%(16/36), 52.78(19/39) and 61.11%(22/36) respectively, HBeAb positive conversion rate were 33.33%(12/36), 44.44%(16/36) and 50.00%(18/36), HBeAg seroconversion rate were 27.78%(10/36), 44.44%(16/36) and 50.00%(18/36), HBVDNA negative conversion rate were 38.89%(14/36), 44.44%(16/36), and 66.67%(24/36), ALT normalization rate were 19.44%(7/36), 55.56%(20/36) and 72.22%(26/36), and HBeAg seroconversion rate was 22.22%(4/18), 33.33%(6/18) and 33.33%(6/18) in patients with ALT≤2ULN, and 33.33%(6/18), 55.56%(10/18) and 66.67%(12/18) in those with ALT>2ULN.
Conclusions: anti-HBV-DC vaccine in combination with lamivudine and thymosin-α1 can be considered as a safe approach with high efficacy for HBeAg positive CHB patients, which may effectively inhibit the viral replication, lower rapidly HBsAg, HBeAg and HBVDNA, improve the production of HBeAb, and increase the HBeAg seroconversion rate.


Author Keywords: Dendritic cells (DC); Hepatitis B virus (HBV); Chronic hepatitis B (CHB); Vaccine