Evaluation of safety and immunogenicity of hepatitis E vaccine in maintenance hemodialysis patients

• Published in: Zhōnghuá yùfáng-yīxué zázhì Vol. 56; no. 4; p. 464
• Main Authors: Wang, X L, Li, Y T, Ma, X J, Ling, Y S, Wu, T, Niu, J J
• Format: Journal Article
• Language: Chinese
• Published: China 06-04-2022
• Subjects: Clinical Trials, Phase III as Topic; Female; Hepatitis E; Humans; Immunogenicity, Vaccine; Immunoglobulin G; Male; Renal Dialysis; Viral Hepatitis Vaccines - adverse effects
• ISSN: 0253-9624
• DOI: 10.3760/cma.j.cn112150-20220223-00168

To evaluate the safety and immunogenicity of hepatitis E vaccine(HEV)in Maintenance hemodialysis(MHD)patients.
Based on an open-labeled controlled trial, from May 2016 to March 2018, 35 eligible MHD patients were recruited in the Hemodialysis Center of Zhongshan Hospital Affiliated to Xiamen University as the experimental group, and 70 MHD patients with matched age, gender and underlying diseases as the control group. The experimental group received HEV at 0, 1 and 6 months according to the standard vaccination procedures, while the control group received routine diagnosis and treatment without vaccine and placebo injection to observe the safety and immunogenicity of the vaccine. The safety of vaccine in MHD population was evaluated by the incidence of adverse reactions/events in the experimental and control groups. The immunogenicity of HEV in MHD patients was evaluated by comparing the data from the phase Ⅲ clinical trial.
The overall incidence of adverse reactions/events was 17.1% (18/105), and there were