2型糖尿病患者接种乙型肝炎疫苗后12个月的持续免疫原性及无应答者再次接种的免疫原性：一项开放标签随机对照试验
12 Months Persistent Immunogenicity after Hepatitis B Vaccination in Patients with Type 2 Diabetes and Immunogenicity of Revaccination in Non-Responders: An Open-Label Randomized Controlled Trial.
作者信息
Han Bingfeng, Liu Wu, Du Juan, Liu Hanyu, Zhao Tianshuo, Yang Shubo, Wang Shuai, Zhang Sihui, Liu Bei, Liu Yaqiong, Cui Fuqiang
机构信息
Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing 100191, China.
Jingyuan County Center for Disease Control and Prevention, Baiyin 730600, China.
出版信息
Vaccines (Basel). 2021 Nov 29;9(12):1407. doi: 10.3390/vaccines9121407.
BACKGROUND
In initial studies, the immunogenicity and safety of hepatitis B vaccines in patients with diabetes has been assessed in China.
METHODS
In six township health centers in Gansu Province, 232 diabetic patients and 77 healthy people were allocated to receive two 3-dose hepatitis B vaccines (Group D20SC 0-1-6; Group D20CHO 0-1-6; Group ND20SC 0-1-6). Participants were followed up at 12 months after being fully vaccinated. One dose of the vaccine was randomly administered to non-responders. Chi-square test was used to compare the differences in response rate between two groups.
RESULTS
The anti-HBs response rates of three groups decreased from 84.1%, 89.1% and 88.3% at one month to 64.6%, 79.8% and 71.4% at twelve months. There was no statistical difference in the immune response rates between Group D20SC 0-1-6 and Group ND20SC 0-1-6; however, that of Group D20CHO 0-1-6 was higher than that of Group D20SC 0-1-6. After revaccination, the geometric mean concentrations were 491.7 mIU/mL and 29.7 mIU/mL after using vaccines containing 60 μg and 20 μg HBsAg.
CONCLUSIONS
At 12 months, immune response in diabetic patients were not significantly different from that in healthy people. Revaccination with one dose of hepatitis B vaccine containing 60 μg HBsAg for non-responders was more satisfactory.
背景
在中国，已对糖尿病患者中乙型肝炎疫苗的免疫原性和安全性进行了初步研究。
方法
在甘肃省的6个乡镇卫生院，将232名糖尿病患者和77名健康人分配接受两剂3针次的乙型肝炎疫苗（D20SC 0-1-6组；D20CHO 0-1-6组；ND20SC 0-1-6组）。在全程接种疫苗后12个月对参与者进行随访。对无应答者随机接种一剂疫苗。采用卡方检验比较两组应答率的差异。
结果
三组的抗-HBs应答率从1个月时的84.1%、89.1%和88.3%降至12个月时的64.6%、79.8%和71.4%。D20SC 0-1-6组和ND20SC 0-1-6组的免疫应答率无统计学差异；然而，D20CHO 0-1-6组的免疫应答率高于D20SC 0-1-6组。再次接种后，使用含60μg和20μg HBsAg的疫苗后几何平均浓度分别为491.7 mIU/mL和29.7 mIU/mL。
结论
在12个月时，糖尿病患者的免疫应答与健康人无显著差异。对无应答者接种一剂含60μg HBsAg的乙型肝炎疫苗进行再次接种效果更佳。
Zotero 插件