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A clinical trial on anti-HBV-DC combined with lamivudine and thymosin-a1 in the HBeAg positive patients of chronic hepatitis B virus infection
发布时间: 2013-05-08    人气指数:1082

ILC 2013 ---48th annual meeting of the European Association for the Study of the Liver

Poster 781

Journal of Hepatology. 2013, 58 (suppl No.1):s318.


B.-F. Wu1,2*, J.-Y. Yang2, Y.-L. Zhang3, Y. Liu1, H.-H. Zhou3, X.-Q. Wang1, F.-Q. Li1, C.-Q. Hou3, X.-S. Li1, X.-H. Huang1, Z.-S. Xiao1, M. Yang1, F.-X. Lin3, Y.-P. Fu3, S. Zheng3, W. Chen3, Y. Zhou2, J. Yang2, X.-H. Wan1, H. Huang1


1Gastroenterology and Hepatology Center, Southern Medical University Renkang Hospital, Dongguan, 2Guangzhou Pubang Bio-Immunological Tech Research Institute, Guangzhou, 3Gastroenterology and Hepatology Center, Tongji Medical College Affiliated Dongguan Hospital, Huazhong University of Science and Technology, Dongguan, China. *bangfu.wu@163.com


Background and aims: To observe the clinical efficacy of anti-HBV-DC vaccine, the dendritic cells(DC) originating from peripheral blood mononuclear cells(PBMC) sensitized by HBsAg, in combination with lamivudine and thymosin-α1, in HBeAg positive patients of chronic hepatitis B virus(HBV) infection.

Methods: 55 HBeAg positive patients including 40 males and 15 females aged 15-54 years were recruited in the study including 19 chronic HBV carriers, 18 chronic hepatitis B(CHB) patients with ALT≤2ULN and 18 CHB patients 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. Quantitative HBVM(TRFIA) and HBVDNA and hepatic functions were evaluated at week 0, 4, 12, and 24.
Results: Mean of HBsAg, HBeAg and HBVDNA 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 36.36%(20/55), 40.00(22/55) and 45.46%(25/55) respectively in all patients, HBeAb positive conversion rate were 25.46%(14/55), 36.36%(20/55) and 38.18%(21/55), HBeAg seroconversion rate were 21.82%(12/55), 34.56%(19/55) and 38.18%(21/55), HBVDNA negative conversion rate were 32.73%(18/55), 36.36%(20/55), and 56.36%(31/55), ALT normalization rate were 19.44%(7/36), 55.56%(20/36) and 72.22%(26/36), and HBeAg seroconversion rate was 10.53%(2/19), 15.79%(3/19) and 15.79%(3/19) in chronic HBV carriers, 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 patients with ALT>2ULN.
The rate of adverse effect was 3.33% observed in re-infusion of anti-HBV-DC vaccine.
Conclusions: anti-HBV-DC vaccine in combination with lamivudine and thymosin-α1 can be considered as a safe and efficient approach for HBeAg positive 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); Hepatitis B virus carriers; Vaccine