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A Clinical Trial on Anti-HBV-DC Vaccine Combined with Lamivudine and Thymosin-α1 in the HBeAg Positive Chronic Hepatitis B Virus Carriers
发布时间: 2013-12-01    人气指数:1132

The Liver Meeting 2013---The 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD)

Poster Sessions (Abstract 1022)

Hepatology. 2013, 58 (4): 700A-701A.


Bang-Fu Wu1, 2, Jiang-Ying Yang1


1. Gastroenterology and Hepatology Center, Southern Medical University Renkang HospitalDongguanGuangdong,China


2. Guangzhou Pubang Bio-Immunological Tech Research Institute, GuangzhouGuangdongChina.



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 virus(HBV) carriers.

Methods: 19 HBeAg positive chronic HBV carriers were recruited in the trial including 15 males and 4 females aged 14-54 years. 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 after therapy of 4, 12 and 24 weeks. At week 4, 12 and 24, HBeAg negative conversion rate were 21.05%(4/19), 15.79(3/19) and 15.79%(3/19) respectively, HBeAb positive conversion rate were 10.53%(2/19), 21.05%(4/19) and 15.79%(3/19), HBeAg seroconversion rate were 10.53%(2/19), 15.79%(3/19) and 15.79%(3/19), HBVDNA negative conversion rate were 21.05%(4/19), 21.05%(4/19), and 36.84%(7/19), ALT abnormal increased rate were 5.26%(1/19), 10.53%(2/19) and 15.79%(3/19).The rate of adverse effect was 3.07% 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 approach for HBeAg positive chronic HBV carriers, which may effectively inhibit the viral replication, lower HBsAg, HBeAg and HBVDNA, improve the production of HBeAb, and increase the HBeAg seroconversion rate.