Immunogenicity and safety of hepatitis E vaccine in healthy hepatitis B surface antigen positive adults

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	Immunogenicity and safety of hepatitis E vaccine in healthy hepatitis B surface antigen positive adults
	Wu, Ting ; Huang, Shou-Jie ; Zhu, Feng-Cai ; Zhang, Xue-Feng ; Ai, Xing ; Yan, Qiang ; Wang, Zhong-Ze ; Yang, Chang-Lin ; Jiang, Han-Min ; Liu, Xiao-Hui ; Guo, Meng ; Du, Hai-Lian ; Ng, Mun-Hon ; Zhang, Jun ; Xia, Ning-Shao ; Wu T(吴婷) ; Du HL(杜海莲) ; Zhang J(张军) ; Xia NS(夏宁邵)
刊名	http://dx.doi.org/10.4161/hv.25814
	2013
关键词	CHRONIC LIVER-DISEASE E VIRUS NATURAL-HISTORY INFECTION FULMINANT DECOMPENSATION FRANCE AREA
英文摘要	National Major Scientific and Technological Special Project for the "Prevention and Control of Important Infectious Diseases" [2012ZX10002001, 2011ZX10004-903]; National Major Scientific and Technological Special Project for "Significant New Drug Development" [2013ZX09101017]; A recombinant hepatitis E vaccine, Hecolin (R), has been proven safe and effective in healthy adults. As hepatitis B surface antigen (HBsAg) positive individuals have a higher risk of poor prognosis after super-infection with hepatitis E virus (HEV), the safety and immunogenicity of Hecolin (R) in this population should be assessed. The present study is an extending analysis of data from a large randomized controlled clinical trial of Hecolin (R). Healthy participants (n = 14 065) without current or previous evidence of chronic liver disease were randomized to receive Hecolin (R) or placebo (hepatitis B vaccine) and donated their blood samples before vaccination and subsequently over 31 mo. Most of the adverse events were mild and comparable between participants with and without baseline hepatitis B surface antigen (HBsAg). No vaccine-related serious adverse events were reported. Rates of serious adverse events in HBsAg (+) or HBsAg (-) participants were also comparable between both groups. Almost all participants in the Hecolin (R) group seroconverted to anti-HEV one month after full vaccination. The antibody response rates and levels were similar in HBsAg (+) and HBsAg (-) participants (98.38%, 19.32 Wu/mL vs. 98.69%, 19.00 Wu/mL). The two-year antibody dynamics of HBsAg (+) participants overlapped perfectly with those of HBsAg (-) participants. In conclusion, the safety and immunogenicity of Hecolin (R) for HBsAg (+) adults is very similar to that for the general population.
语种	英语
出版者	LANDES BIOSCIENCE
内容类型	期刊论文
源URL	[http://dspace.xmu.edu.cn/handle/2288/93453]
专题	医学院－已发表论文
推荐引用方式 GB/T 7714	Wu, Ting,Huang, Shou-Jie,Zhu, Feng-Cai,et al. Immunogenicity and safety of hepatitis E vaccine in healthy hepatitis B surface antigen positive adults[J]. http://dx.doi.org/10.4161/hv.25814,2013.
APA	Wu, Ting.,Huang, Shou-Jie.,Zhu, Feng-Cai.,Zhang, Xue-Feng.,Ai, Xing.,...&夏宁邵.(2013).Immunogenicity and safety of hepatitis E vaccine in healthy hepatitis B surface antigen positive adults.http://dx.doi.org/10.4161/hv.25814.
MLA	Wu, Ting,et al."Immunogenicity and safety of hepatitis E vaccine in healthy hepatitis B surface antigen positive adults".http://dx.doi.org/10.4161/hv.25814 (2013).