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学科主题临床医学
A pilot randomized controlled trial of dual-plasmid HBV DNA vaccine mediated by in vivo electroporation in chronic hepatitis B patients under lamivudine chemotherapy
Yang, F. -Q.1; Yu, Y. -Y.2; Wang, G. -Q.2; Chen, J.3; Li, J. -H.4; Li, Y. -Q.5; Rao, G. -R.1; Mo, G. -Y.1; Luo, X. -R.1; Chen, G. -M.1
关键词Chronic Hepatitis b Dna Vaccine Hepatitis b Virus Lamivudine-resistant Mutants t Cell
刊名JOURNAL OF VIRAL HEPATITIS
2012-08-01
DOI10.1111/j.1365-2893.2012.01589.x
19期:8页:581-593
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Gastroenterology & Hepatology ; Infectious Diseases ; Virology
研究领域[WOS]Gastroenterology & Hepatology ; Infectious Diseases ; Virology
关键词[WOS]T-CELL RESPONSES ; VIRUS-INFECTION ; NATURAL-HISTORY ; IMMUNE-RESPONSE ; THERAPY ; COMBINATION ; IMMUNOLOGY ; INDUCTION ; ANTIBODY ; CARRIERS
英文摘要

. A DNA vaccine against the hepatitis B virus (HBV), enhanced by IL-2/IFN-? fusion protein expression from a plasmid construct and mediated by in vivo electroporation, was evaluated in a total of 39 HBeAg-positive patients with chronic hepatitis B (CHB). The six of 39 patients with a serum alanine aminotransferase (ALT) value of 12 times upper limit of normal (ULN) were assigned to the open-label arm (Group01) receiving vaccine monotherapy; the remaining 33 patients with an ALT of more than two times ULN were enroled to the randomized and controlled arm (Group02) receiving lamivudine (LAM) monotherapy (LAM+placebo) or combined therapy (LAM+DNA vaccine) in 1:2 ratio. In Group01, a significant elevation of HBV-specific IFN-?-secreting T-cell counts in comparison with baseline was observed. In Group02, the proportion of patients with HBV DNA suppression was higher with LAM+DNA vaccine than with LAM monotherapy at each visit time point after the final injection of DNA vaccine at week 36, revealing a significant difference between the two groups (P = 0.03) at week 60. The incidence of dual-site mutations of rtM204/I/S+rtL180M was significantly lower (P = 0.03) with an identified lower virological breakthrough (VBT) rate (P = 0.03) in patients receiving LAM+DNA vaccine than LAM monotherapy, accompanied with a significant higher positive T-cell response rate in patients receiving LAM+DNA vaccine (P = 0.03). In conclusion, this study provides evidence that HBV DNA vaccination is safe and immunologically effective, and that the HBV-specific T-cell responses induced by DNA vaccination under LAM chemotherapy showed a correlation with the suppression of viral replication in patients with CHB.

语种英语
WOS记录号WOS:000306006600008
项目编号2009B030801276 ; 2008ZX10002-003
资助机构Guangdong Provincial Sci. Tech. Project ; National Key Program Grant
引用统计
被引频次:32[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/55021
专题北京大学第一临床医学院_感染疾病科
作者单位1.Guangzhou 458 Hosp, Liver Dis Res Ctr, Guangzhou 510600, Guangdong, Peoples R China
2.Peking Univ, Dept Infect Dis, Hosp 1, Beijing 100871, Peoples R China
3.Ditan Hosp, Beijing, Peoples R China
4.Youan Hosp, Beijing, Peoples R China
5.Beijing 302 Hosp, Beijing, Peoples R China
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Yang, F. -Q.,Yu, Y. -Y.,Wang, G. -Q.,et al. A pilot randomized controlled trial of dual-plasmid HBV DNA vaccine mediated by in vivo electroporation in chronic hepatitis B patients under lamivudine chemotherapy[J]. JOURNAL OF VIRAL HEPATITIS,2012,19(8):581-593.
APA Yang, F. -Q..,Yu, Y. -Y..,Wang, G. -Q..,Chen, J..,Li, J. -H..,...&Chen, G. -M..(2012).A pilot randomized controlled trial of dual-plasmid HBV DNA vaccine mediated by in vivo electroporation in chronic hepatitis B patients under lamivudine chemotherapy.JOURNAL OF VIRAL HEPATITIS,19(8),581-593.
MLA Yang, F. -Q.,et al."A pilot randomized controlled trial of dual-plasmid HBV DNA vaccine mediated by in vivo electroporation in chronic hepatitis B patients under lamivudine chemotherapy".JOURNAL OF VIRAL HEPATITIS 19.8(2012):581-593.
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