糖尿病患者接种重组CHO乙型肝炎疫苗的免疫原性和安全性

Immunogenicity and safety of recombinant CHO-based hepatitis B vaccine in diabetes patients

目的探讨糖尿病患者接种重组CHO乙型肝炎疫苗(Hepatitis B vaccine,HepB)的免疫原性和安全性。方法采用分层随机抽样在枣庄市3个社区选择10-69岁、无HepB接种史、乙肝表面抗原(Hepatitis B surface antigen,HBsAg)和乙肝表面抗体(Hepatitis B surface antibody,HBsAb)均阴性的糖尿病患者,按照0-1-6月免疫程序接种20μg重组CHO HepB,采用化学发光微粒子免疫分析法检测血清HBsAb,观察每剂次接种后0-28d不良反应,分析HBsAb阳转率、几何平均浓度(Geometric mean concentration,GMC)和不良反应发生率。结果共纳入212名受试者,HepB全程接种后HBsAb阳转率为88.21%,GMC为585.73mIU/mL;<30岁、30-39岁、40-49岁和≥50岁受试者HBsAb阳转率分别为84.09%、90.70%、87.50%和89.41%(χ^(2)=1.11,P=0.774),GMC分别为552.33、504.43、574.51和656.45mIU/mL(F=0.23,P=0.876)。接种后总不良反应发生率为10.69%(68/636),均为一般反应。结论糖尿病患者接种重组CHO HepB具有良好的免疫原性和安全性。

Objective To explore the immunogenicity and safety of recombinant CHO-based hepatitis B vaccine(HepB) in diabetes patients.Methods We used a stratified random sampling method to recruit 10-69-year-old diabetes patients without HepB vaccination history in three communities of Zaozhuang city who were negative to hepatitis B virus surface antigen(HBsAg) and hepatitis B virus surface antibody(HBsAb). Subjects received three doses of 20μg recombinant CHO-based HepB in a 0-1-6-month schedule. We tested sera for HBsAb using chemiluminescence microparticle immunoassays and observed vaccinees for adverse reactions for 28 days after each dose. We determined seroconversion rates, geometric mean concentrations(GMC) of HBsAb, and the incidence of adverse reactions.Results Among the 212 subjects enrolled, 88.21% seroconverted after full-series HepB vaccination, and the HBsAb GMC was 585.73 mIU/mL. Seroconversion rates for <30-, 30-39-, 40-49-, and ≥50-year-olds were 84.09%, 90.70%, 87.50%, and 89.41%(χ^(2)=1.11, P=0.774) with GMCs being 552.33, 504.43, 574.51, and 656.45 mIU/mL(F=0.23, P=0.876). The incidence of adverse reactions within 28 days after vaccination was 10.69%(68/636), and all reactions were common.Conclusions Recombinant CHO-based HepB was immunogenic and safe in diabetes patients.