title: Immunogenicity and safety of hepatitis E vaccine in healthy hepatitis B surface antigen positive adults.
abstract: A recombinant hepatitis E vaccine, Hecolin, 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 in this population should be assessed. The present study is an extending analysis of data from a large randomized controlled clinical trial of Hecolin. Healthy participants (n = 14,065) without current or previous evidence of chronic liver disease were randomized to receive Hecolin 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 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 for HBsAg (+) adults is very similar to that for the general population.
authors.affiliation: National Institute of Diagnostics and Vaccine Development in Infectious Diseases; School of Public Health; Xiamen University; Xiamen, P.R. China.
authors.forename: Ting
authors.initials: T
authors.lastname: Wu
authors.forename: Shou-Jie
authors.initials: SJ
authors.lastname: Huang
authors.forename: Feng-Cai
authors.initials: FC
authors.lastname: Zhu
authors.forename: Xue-Feng
authors.initials: XF
authors.lastname: Zhang
authors.forename: Xing
authors.initials: X
authors.lastname: Ai
authors.forename: Qiang
authors.initials: Q
authors.lastname: Yan
authors.forename: Zhong-Ze
authors.initials: ZZ
authors.lastname: Wang
authors.forename: Chang-Lin
authors.initials: CL
authors.lastname: Yang
authors.forename: Han-Min
authors.initials: HM
authors.lastname: Jiang
authors.forename: Xiao-Hui
authors.initials: XH
authors.lastname: Liu
authors.forename: Meng
authors.initials: M
authors.lastname: Guo
authors.forename: Hai-Lian
authors.initials: HL
authors.lastname: Du
authors.forename: Mun-Hon
authors.initials: MH
authors.lastname: Ng
authors.forename: Jun
authors.initials: J
authors.lastname: Zhang
authors.forename: Ning-Shao
authors.initials: NS
authors.lastname: Xia
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000914:Antibodies, Viral / Q000097:blood; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D006509:Hepatitis B / Q000150:complications*; D006514:Hepatitis B Surface Antigens / Q000097:blood*; D016751:Hepatitis E / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008875:Middle Aged; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D014761:Viral Hepatitis Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D055815:Young Adult
chemical_list: D000914:Antibodies, Viral; D006514:Hepatitis B Surface Antigens; D014614:Vaccines, Synthetic; D014761:Viral Hepatitis Vaccines; C577000:hecolin
keywords: HBsAg; HEV239; Hecolin®; hepatitis E; immunogenicity; safety; vaccine