Safety and immunogenicity of thiomersal-free recombinant hepatitis E vaccine: A randomized, double-blind, active-controlled study

IF 4.5 3区医学 Q2 IMMUNOLOGY

Vaccine Pub Date : 2025-07-20 DOI:10.1016/j.vaccine.2025.127510

Junrong Li , Xiujuan Wang , Dengxiang Zhang , Fangqin Xie , Sumei Zhong , Xiaoshan Yu , Shasha Chen , Qinbiao Huang , Rui Wang , Qiufen Zhang , Dongjuan Zhang

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引用次数: 0

Abstract

Introduction

The first recombinant hepatitis E vaccine (Escherichia Coli), Hecolin® (Xiamen Innovax, China), was approved for people aged ≥16 years. Innovax has developed a thiomersal-free formulation process change according to the requirement of 2020 Chinese Pharmacopoeia. This study aimed to evaluate the safety and immunogenicity of the thiomersal-free hepatitis E vaccine compared with the licensed hepatitis E vaccine in people aged ≥16 years. Clinical Trial Registration: NCT06564116.

Methods

This was a single-center, randomized, double-blind, active-controlled study conducted in China. Eligible participants were randomly assigned in a 1:1 ratio to the thiomersal-free hepatitis E vaccine group (HEV-TF group) or the hepatitis E vaccine group (HEV group) stratified by sex and age. Each participant received three doses of the vaccine intramuscularly at 0, 1 and 6 months. Safety was evaluated based on adverse events (AEs) occurred within 30 days following each dose, serious adverse events (SAEs) and pregnancy events occurred during the study period. Immunogenicity was evaluated through quantification of anti-HEV IgG in serum samples collected at 0 and 7 months.

Results

A total of 612 eligible participants were enrolled and received at least 1 dose of vaccine. 558 participants were included in the per protocol set for immunogenicity. All participants seroconverted in both groups by month 7. The seroconversion rate difference was 0.00 % (95 % confidence interval [CI] -1.38 to 1.34). The geometric mean concentrations (GMCs) in HEV-TF group and HEV group were 16.57 U/mL and 18.47 U/mL, respectively. The GMC ratio was 0.90 (95 % CI 0.79 to 1.01). The overall AEs rates were similar between the groups (16.88 % vs. 12.50 %). Most of AEs were grade 1 or 2. No vaccine-related SAE occurred during the study period.

Conclusions

The thiomersal-free hepatitis E vaccine demonstrated non-inferior immunogenicity compared with the licensed hepatitis E vaccine Hecolin® and showed an acceptable safety profile.

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无硫柳汞重组戊型肝炎疫苗的安全性和免疫原性：一项随机、双盲、主动对照研究

首个重组戊型肝炎疫苗（大肠杆菌）Hecolin®（厦门Innovax，中国）被批准用于年龄≥16岁的人群。Innovax根据2020年中国药典要求，开发了无硫柳汞配方工艺变更。本研究旨在评价无硫柳汞戊型肝炎疫苗与许可戊型肝炎疫苗在≥16岁人群中的安全性和免疫原性。临床试验注册：NCT06564116。方法在中国进行的单中心、随机、双盲、主动对照研究。符合条件的参与者按性别和年龄按1:1的比例随机分配到无硫柳汞戊型肝炎疫苗组（HEV- tf组）或戊型肝炎疫苗组（HEV组）。每位参与者在0、1和6个月时接受了三剂肌肉注射疫苗。安全性评估基于每次给药后30天内发生的不良事件（ae）、研究期间发生的严重不良事件（sae）和妊娠事件。免疫原性通过在0和7个月时采集的血清样本中定量检测抗hev IgG来评估。结果共有612名符合条件的受试者接受了至少1剂疫苗接种。558名参与者被纳入免疫原性方案集。在第7个月，两组的所有参与者都转化为血清。血清转换率差异为0.00 %（95%置信区间[CI] -1.38 ~ 1.34）。HEV- tf组和HEV组的几何平均浓度分别为16.57 U/mL和18.47 U/mL。GMC比值为0.90 （95% CI 0.79 ~ 1.01）。两组间总体ae发生率相似（16.88% vs 12.50%）。大多数ae为1级或2级。在研究期间未发生与疫苗相关的SAE。结论无硫柳汞戊型肝炎疫苗的免疫原性优于已获批的戊型肝炎疫苗Hecolin®，且具有可接受的安全性。

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来源期刊

Vaccine 医学-免疫学

CiteScore

8.70

自引率

5.50%

发文量

992

审稿时长

131 days

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