The Health Thread | Nepal Health News & IPAC

Abstract

Objective: To investigate the antibody persistence and influencing factors of the simplified two-dose and standard three-dose hepatitis B vaccine (HepB) among people aged 15-40 years after 20 years of primary immunization. Methods: In November 2003, a total of 1 994 healthy people aged 15-40 were randomly selected from 20 villages in Jiyang County, Jinan City, Shandong Province. Venous blood samples were collected from 3-5 ml of people who tested negative for hepatitis B surface antigen (HBsAg), anti-hepatitis B surface antibody (anti-HBs), and anti-hepatitis B core antibody (anti-HBc). A total of 850 people were included in the study. The study randomly assigned 428 people to the "0-1-6" immunization program group and 422 people to the "0-6" immunization program group, and administered primary immunization to people using 10 μg HepB according to the corresponding program. 629 people completed full immunization and underwent blood sampling and anti-HBs testing one month after immunization. Blood samples were collected at 1 month, 12 years (2015), and 20 years (2023) after primary immunization, and solid-phase radioimmunoassay (SPRIA) or chemiluminescence particle immunoassay (CMIA) were used to detect anti-HBs, HBsAg, and anti-HBc. Simultaneously, a questionnaire survey was conducted, and information on birth date, gender, vaccination time, HepB immunization history, smoking history, alcohol consumption history, chronic disease history, and family members' hepatitis B infection history were collected during the baseline survey and follow-up survey. The generalized estimation equation (GEE) was used to analyze the main effects, interaction effects, and influencing factors of anti-HBs seropositive rates and geometric mean concentration (GMC). Results: A total of 304 people were followed up at 1 month, 12 years (2015), and 20 years (2023) after primary immunization, with 50.99% (155 people) in the "0-1-6" immunization program group. In 2003, 2015, and 2023, the seropositive rates of anti-HBs in the "0-1-6" immunization program group were 94.19% (95%CI: 89.26%-97.31%), 74.19% (95%CI: 66.56%-80.88%), and 69.68% (95%CI: 61.79%-76.79%), respectively. The seropositive rates of anti-HBs in the "0-6" immunization program group were 87.25% (95%CI: 80.80%-92.14%), 55.03% (95%CI: 46.68%-63.18%), and 51.01% (95%CI: 42.70%-59.28%), respectively. In 2003, 2015, and 2023, the anti-HBs GMC of the "0-1-6" immunization program group were 268 (95%CI: 200-359) mIU/ml, 34 (95%CI: 26-46) mIU/ml, and 37 mIU/ml (95%CI: 27-51), respectively. The anti-HBs GMC of the "0-6" immunization program group were 121 (95%CI: 87-168) mIU/ml, 13 (95%CI: 9-18) mIU/ml, and 15 (95%CI: 11-20) mIU/ml, respectively. The main effects analysis of GEE showed that there were statistically significant differences in the anti-HBs seropositive rates and GMC between the "0-1-6" immunization program group and the "0-6" immunization program group (both P<0.001). Compared with 2003, the anti-HBs seropositive rate and GMC were lower in 2015 and 2023 (both P<0.001). There was no interaction effect between the seropositive rate of anti-HBs and the follow-up time of anti-HBs GMC and the immunization program (both P>0.05). The multivariate analysis of GEE showed that compared with the "0-1-6" immunization program group and the 2003 baseline, the "0-6" immunization program group (OR=0.45, 95%CI: 0.30-0.68, P<0.001) had lower anti-HBs seropositive rates in 2015 and 2023 (OR=0.17, 95%CI: 0.12-0.25, P<0.001; OR=0.14, 95%CI: 0.10-0.20, P<0.001). Compared with the "0-1-6" immunization program group, baseline in 2003, and without chronic disease history, people in the "0-6" immunization program group (β=-0.83, 95%CI:-1.19--0.47, P<0.001) had lower anti-HBs GMC in 2015 and 2023 (β=-2.15, 95%CI:-2.37--1.93, P<0.001; β=-2.04, 95%CI:-2.27--1.80, P<0.001), and those with chronic disease history (β=0.55, 95%CI: 0.02-1.08, P=0.043). Conclusion: Compared with those receiving three-dose HepB, people receiving two-dose HepB have lower anti-HBs seropositive rates and GMC. Seropositive rates are associated with immunization program and follow-up duration, while the anti-HBs GMCs are associated with immunization program, follow-up duration, and chronic disease history. 目的： 探讨15~40岁人群基础免疫乙型肝炎疫苗（HepB）简化2剂次和现行3剂次20年后的抗体持久性及其影响因素。 方法： 于2003年11月，在山东省济南市济阳区，采用单纯随机抽样方法抽取20个村庄的15~40岁健康人群共1 994名，采集静脉血3~5 ml，HBsAg、抗-HBs和抗-HBc检测均阴性者，共计850名研究对象纳入研究。将这些研究对象随机分配至“0-1-6”免疫程序组（428名）和“0-6”免疫程序组（422名），按照对应程序使用10 μg HepB对参与者进行基础免疫；629名完成全程免疫及免疫后一个月的采血和抗-HBs检测。分别于基础免疫后1个月、12年（2015年）和20年（2023年）采集血标本，采用固相放射免疫法或化学发光微粒子免疫分析法检测抗-HBs、HBsAg和抗-HBc；同时进行问卷调查，于基线调查和随访调查时分别收集出生日期、性别、接种时间、HepB免疫史、吸烟史、饮酒史、慢性病史、家庭成员乙肝感染史信息。采用广义估计方程分析抗-HBs阳性和抗-HBs 几何均值（GMC）的主效应、交互效应及其影响因素。 结果： 基础免疫后1月、12年（2015年）和20年（2023年）共304名研究对象接受了随访，“0-1-6”免疫程序组对象占50.99%（155名）。2003、2015和2023年，“0-1-6”免疫程序组的抗-HBs阳性率分别为94.19 %（95%CI：89.26%~97.31%）、74.19%（95%CI：66.56%~80.88%）和69.68%（95%CI：61.79%~76.79%）；“0-6”免疫程序组的抗-HBs阳性率分别为87.25%（95%CI：80.80%~92.14%）、55.03%（95%CI：46.68%~63.18%）和51.01%（95%CI：42.70%~59.28%）。2003、2015和2023年，“0-1-6”免疫程序组的抗-HBs GMC分别为268（95%CI：200~359）mIU/ml、34（95%CI：26~46）mIU/ml和37 mIU/ml（95%CI：27~51）；“0-6”免疫程序组的抗-HBs GMC分别为121（95%CI：87~168）mIU/ml、13（95%CI：9~18）mIU/ml和15（95%CI：11~20）mIU/ml。广义估计方程主效应分析结果显示，“0-1-6”程序组与“0-6”程序组的抗-HBs阳性率、抗-HBs GMC差异均有统计学差异（均P<0.001）；与2003年相比，2015年和2023年，抗-HBs 阳性率和GMC均较低（均P<0.001）。抗-HBs阳性率和抗-HBs GMC的随访时间与免疫程序不存在交互效应（均P>0.05）。广义估计方程多因素分析结果显示，与“0-1-6”程序、2003年基线相比，“0-6”程序组（OR=0.45，95%CI：0.30~0.68，P<0.001）、2015年和2023年（OR=0.17，95%CI：0.12~0.25，P<0.001；OR=0.14，95%CI：0.10~0.20，P<0.001）的抗-HBs 阳性率更低；与“0-1-6”程序、2003年基线、无慢性病史相比，“0-6”程序组（β=-0.83，95%CI：-1.19~-0.47，P<0.001）、2015年和2023年（β=-2.15，95%CI：-2.37~-1.93，P<0.001；β=-2.04，95%CI：-2.27~-1.80，P<0.001）、有慢性病史（β=0.55，95%CI：0.02~1.08，P=0.043）的参与者抗-HBs GMC更低。 结论： 与接种3剂次HepB疫苗者相比，接种2剂次者的抗体阳性率和GMC均较低；抗体阳性率与免疫程序和随访时间有关，抗体GMC与免疫程序、随访时间和慢性病史有关。.

[Comparison of antibody persistence after two-dose and three-dose hepatitis B vaccines for 20 years among people aged 15-40 years in Shandong Province].

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Abstract