免疫原性、抗体持久性和 60μg 乙肝疫苗在血液透析患者中的安全性：一项多中心、随机、双盲、平行对照试验。
Immunogenicity, antibody persistence, and safety of the 60 μg hepatitis B vaccine in hemodialysis patients: a multicenter, randomized, double-blind, parallel-controlled trial.
机构信息
a School of Public Health , Shanxi Medical University , Taiyuan , Shanxi , PR China.
b Clinical Laboratory , Heping Hospital of Changzhi Medical College , Changzhi , Shanxi , PR China.
出版信息
Expert Rev Vaccines. 2017 Oct;16(10):1045-1052. doi: 10.1080/14760584.2017.1367667. Epub 2017 Aug 21.
BACKGROUND
To evaluate the immunogenicity, antibody persistence, and safety of the 60 µg hepatitis B vaccine in hemodialysis patients in China.
METHODS
We conducted a multicenter, randomized, double-blind, parallel-controlled trial including 352 hemodialysis patients who were centrally randomized in a ratio of 1:1 to receive a 20 µg (IM20 group) or 60 µg (IM60 group) recombinant hepatitis B vaccine at months 0, 1, and 6.
RESULTS
The vaccine-elicited antibody responses peaked at month 7, and declined at month 12. At month 7, the IM60 group had stronger GMC of anti-HBs, and a higher proportion of seroconversion and high-level response than the IM20 group did (P < 0.05). Better immune responses were observed in the IM60 group, especially for those aged or in the high-frequency hemodialysis population.
CONCLUSION
The high dose 60 µg recombinant hepatitis B vaccines elicited stronger immune responses than the 20 µg hepatitis B vaccine did among hemodialysis patients.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, number NCT02963714.
背景
评估 60μg 乙型肝炎疫苗在中国血液透析患者中的免疫原性、抗体持久性和安全性。
方法
我们进行了一项多中心、随机、双盲、平行对照试验，纳入了 352 名血液透析患者，他们按 1:1 的比例进行中央随机分组，分别接受 20μg（IM20 组）或 60μg（IM60 组）重组乙型肝炎疫苗，在第 0、1 和 6 个月接种。
结果
疫苗诱导的抗体反应在第 7 个月达到峰值，然后在第 12 个月下降。在第 7 个月时，IM60 组的抗-HBsGMC 更高，血清转换率和高水平反应率也高于 IM20 组（P<0.05）。IM60 组观察到更好的免疫反应，特别是在年龄较大或高频血液透析人群中。
结论
高剂量 60μg 重组乙型肝炎疫苗在血液透析患者中比 20μg 乙型肝炎疫苗产生更强的免疫反应。
临床试验注册
ClinicalTrials.gov，编号 NCT02963714。
Zotero 插件