戊型肝炎疫苗诱导的抗体反应在不同剂量方案和基线血清状态下的持久性。
Persistence of hepatitis E vaccine-induced antibody response across different dosage schedules and baseline serostatus.
作者信息
Zhu Kongxin, Liao Mengjun, Chen Lu, Lu Jiaoxi, Huang Xingcheng, Zhuang Chunlan, Su Yingying, Huang Shoujie, Wu Ting, Zhang Jun, Xia Ningshao
机构信息
State Key Laboratory of Vaccines for Infectious Diseases, Xiang An Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen, China.
National Institute of Diagnostics and Vaccine Development in Infectious Diseases, State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Innovation Platform for Industry-Education Integration in Vaccine Research, NMPA Key Laboratory for Research and Evaluation of Infectious Disease Diagnostic Technology, Xiamen University, Xiamen, China.
出版信息
NPJ Vaccines. 2024 Dec 19;9(1):245. doi: 10.1038/s41541-024-01041-5.
Hepatitis E virus (HEV) infection is a major cause of acute viral hepatitis worldwide. The efficacy and safety of the HEV239 vaccine have been validated, with protection lasting at least 10 years. This study extended the phase 3 trial of HEV239 (NCT01014845), presenting data on the durability of the anti-HEV IgG response elicited by one or two doses in the participants with different baseline serostatus. Over half of baseline seronegative individuals retained detectable antibodies at month 91 after two doses, with geometric mean concentration levels above the detection limit at month 67 (no available data for month 91). Seropositive individuals exhibited more prolonged and higher anti-HEV IgG response. After a single dose, individuals with pre-existing immunity achieved high and sustained antibody levels for over 103 months, comparable to the two-dose regimen. Both single-dose and two-dose HEV239 regimens demonstrated notable immunogenicity and persistence, potentially offering substantial protective benefits.
戊型肝炎病毒（HEV）感染是全球急性病毒性肝炎的主要病因。HEV239疫苗的有效性和安全性已得到验证，其保护作用至少持续10年。本研究扩展了HEV239的3期试验（NCT01014845），提供了不同基线血清学状态参与者中一剂或两剂疫苗引发的抗HEV IgG反应持久性的数据。超过半数的基线血清学阴性个体在两剂疫苗接种后第91个月仍可检测到抗体，在第67个月时几何平均浓度水平高于检测限（第91个月无可用数据）。血清学阳性个体表现出更持久、更高的抗HEV IgG反应。单剂接种后，已有免疫力的个体在超过103个月的时间里达到了高且持续的抗体水平，与两剂接种方案相当。单剂和两剂HEV239接种方案均显示出显著的免疫原性和持久性，可能提供实质性的保护益处。
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