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中华实验和临床感染病杂志(电子版)

中华实验和临床感染病杂志(电子版) ›› 2026, Vol. 20 ›› Issue (04) : 246 -251. doi: 10.3877/cma.j.issn.1674-1358.2026.04.007

短篇论著

60 μg重组乙肝疫苗（酿酒酵母）成人快速免疫后24个月免疫持久性分析
杨海涛1, 张皓明1, 郑景山2, 李华宇2, 张睿2, 刘晓强1,†()   
  1. 1 650034　昆明市，云南省疾病预防控制中心
    2 518106　深圳市，深圳康泰生物制品股份有限公司
  • 收稿日期:2025-07-07 出版日期:2026-08-15
  • 通信作者: 刘晓强
  • 基金资助:
    “十三五”国家科技重大专项(2018ZX10721202)

Immunological persistence for 24 months following rapid immunization with 60 μg recombinant hepatitis B vaccine (saccharomyces cerevisiae) in adults

Haitao Yang1, Haoming Zhang1, Jingshan Zheng2, Huayu Li2, Rui Zhang2, Xiaoqiang Liu1,†()   

  1. 1 Yunnan Provincial Center for Disease Control and Prevention, Kunming 650034, China
    2 Shenzhen Kangtai Biological Products Co., Ltd., Shenzhen 518106, China
  • Received:2025-07-07 Published:2026-08-15
  • Corresponding author: Xiaoqiang Liu
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杨海涛, 张皓明, 郑景山, 李华宇, 张睿, 刘晓强. 60 μg重组乙肝疫苗（酿酒酵母）成人快速免疫后24个月免疫持久性分析[J/OL]. 中华实验和临床感染病杂志(电子版), 2026, 20(04): 246-251.

Haitao Yang, Haoming Zhang, Jingshan Zheng, Huayu Li, Rui Zhang, Xiaoqiang Liu. Immunological persistence for 24 months following rapid immunization with 60 μg recombinant hepatitis B vaccine (saccharomyces cerevisiae) in adults[J/OL]. Chinese Journal of Experimental and Clinical Infectious Diseases(Electronic Edition), 2026, 20(04): 246-251.

目的

分析60 μg重组乙肝疫苗（酿酒酵母）（简称60 μg乙肝疫苗）用于成人快速免疫后24个月的免疫持久性。

方法

收集2021年3月至2022年4月于云南省大姚县疾病预防控制中心入组成人乙肝疫苗快速免疫程序研究项目并至少接种1剂60 μg乙肝疫苗的研究对象共305例，检测乙型肝炎病毒表面抗原（HBsAg）、乙型肝炎病毒表面抗体（HBsAb）及其几何平均抗体滴度（GMC），以评价60 μg乙肝疫苗用于成人快速免疫24个月后的免疫持久性。根据免疫后1个月HBsAb水平将研究对象分为4组：10～＜100 mIU/ml组、100～＜1 000 mIU/ml组、1 000～＜10 000 mIU/ml组和≥10 000 mIU/ml组。采用卡方检验分析不同组患者HBsAb阳性率；采用方差分析比较不同组研究对象HBsAb GMC。

结果

入组305例研究对象中全程免疫后24个月HBsAb≥10 mIU/ml者249例，阳性率为81.64%，HBsAb GMC为121.97 mIU/ml（95%CI：98.41～151.16）。24个月后HBsAb 10～＜100 mIU/ml组、100～＜1 000 mIU/ml组、1 000～＜10 000 mIU/ml组和≥10 000 mIU/ml组研究对象HBsAb阳性率分别为49.25%（33/67）、86.49%（128/148）、96.92%（63/65）和100.00%（25/25），GMC分别为39.26（95%CI：23.41～65.84） mIU/ml、75.71（95%CI：57.91～98.97） mIU/ml、214.80（95%CI：169.38～272.41） mIU/ml和1 503.74（95%CI：772.98～2 925.35） mIU/ml。

结论

60 μg乙肝疫苗用于成人快速免疫程序具有良好的免疫持久性。

关键词: 乙肝疫苗, 快速免疫程序, 免疫持久性
Objective

To investigate the 24 months immune persistence after rapid immunization with 60 μg recombinant hepatitis B vaccine (Saccharomyces cerevisiae) (abbreviated as 60 μg hepatitis B vaccine) in adult recipients.

Methods

This observational study included adults enrolled in the accelerated hepatitis B vaccination program in Dayao County Center for Disease Control and Prevention,Yunnan Province, from March 2021 to April 2022, who received at least one dose of the 60 μg hepatitis B vaccine. Hepatitis B virus surface antigen (HBsAg), hepatitis B virus surface antibody (HBsAb) and geometric mean concentration (GMC) were detected to evaluate the 24 months immunological persistence of the vaccine. The 305 recipients were divided into four groups based on their HBsAb levels at 1 month post-immunization: group with HBsAb 10-＜100 mIU/ml, group with HBsAb 100-＜1 000 mIU/ml, group with HBsAb 1 000-＜10 000 mIU/ml and group with HBsAb≥10 000 mIU/ml. HBsAb positivity rates and HBsAb GMC of patients among different groups were analyzed by Chi-square test and variance analysis (ANOVA), respectively.

Results

Among the 305 enrolled subjects, 249 had HBsAb≥ 10 mIU/ml at 24 months after full-course immunization, with a positive rate of 81.64%, and the HBsAb GMC was 121.97 mIU/ml (95%CI: 98.41-151.16). After 24-month follow-up, the positive rates of HBsAb subgroups 10-＜100 mIU/ml, 100-＜1 000 mIU/ml, 1 000-＜10 000 mIU/ml and≥10 000 mIU/ml were 49.25% (33/67), 86.49% (128/148), 96.92% (63/65) and 100.00% (25/25), respectively; their corresponding GMC values were 39.26 mIU/ml (95%CI: 23.41-65.84), 75.71 mIU/ml (95%CI: 57.91-98.97), 214.80 mIU/ml (95%CI: 169.38-272.41) and 1 503.74 mIU/ml (95%CI: 772.98-2 925.35).

Conclusions

The 60 μg hepatitis B vaccine demonstrates excellent immunogenicity persistence when administered in the adult rapid immunization program.

Key words: Hepatitis B vaccine, Rapid immunization program, Immune persistence
图1 研究对象筛选流程图
表1 400例成人乙肝疫苗快速免疫研究中全分析数据集对象和失访对象人口学特征 [例（%）]
人口学特征 全分析数据集对象（343例） 失访对象（57例） χ2值 P值
性别 0.359 0.549
男 153（44.61） 23（40.35）
女 190（55.39） 34（59.65）
免疫时年龄 3.827 0.281
16～29岁 40（11.67） 9（15.79）
30～39岁 66（19.24） 16（28.07）
40～49岁 110（32.07） 14（24.56）
≥ 50岁 127（37.03） 18（31.58）
表2 主要分析集研究对象免疫后1个月和24个月HBsAb阳性率及GMC
时间 例数 阳性率[例（%）] GMC [mIU/ml（95%CI）]
免疫后1个月 305 305（100.00） 483.65（387.19～604.14）
免疫后24个月 305 249（81.64） 121.97（98.41～151.16）
统计量 χ2 = 61.661a F = 8.653
P值 ＜ 0.001 ＜ 0.001
表3 主要分析集研究对象免疫后1个月不同抗体水平组24个月后HBsAb阳性率和GMC
HBsAb免疫1个月（mIU/ml） 例数 HBsAb阳性率[例（%）] HBsAb GMC[mIU/ml（95%CI）]
10～＜ 100 67 33（49.25） 39.26（23.41～65.84）
100～＜ 1 000 148 128（86.49） 75.71（57.91～98.97）
1 000～＜ 10 000 65 63（96.92） 214.80（169.38～272.41）
≥ 10 000 25 25（100.00） 1 503.74（772.98～2 925.35）
统计量 χ2 = 66.899 F = －42.120
P值 ＜ 0.001 ＜ 0.001
统计量1 χ2 = 33.994 F = －2.282
P1值 ＜ 0.001 0.115
统计量2 χ2 = 37.798 F = －6.063
P2值 ＜ 0.001 ＜ 0.001
统计量3 χ2 = 20.124 F = －8.884
P3值 ＜ 0.001 ＜ 0.001
统计量4 χ2 = 5.311 F = －3.764
P4值 0.021 ＜ 0.001
统计量5 χ2 = 3.820 F = －8.547
P5值 0.051 ＜ 0.001
统计量6 χ2 = 0.787 F = －5.663
P6值 0.375 ＜ 0.001
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