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学科主题: 临床医学
题名:
A pilot randomized controlled trial of dual-plasmid HBV DNA vaccine mediated by in vivo electroporation in chronic hepatitis B patients under lamivudine chemotherapy
作者: 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
发表日期: 2012-08-01
DOI: 10.1111/j.1365-2893.2012.01589.x
卷: 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
所属项目编号: 2009B030801276 ; 2008ZX10002-003
项目资助者: Guangdong Provincial Sci. Tech. Project ; National Key Program Grant
WOS记录号: WOS:000306006600008
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/55021
Appears in Collections:北京大学第一临床医学院_感染疾病科_期刊论文

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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

Recommended Citation:
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.
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