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不同剂量和免疫程序乙型肝炎疫苗在中国健康青年人中的免疫原性比较:一项 2 年随访研究。

Comparison of immunogenicity between hepatitis B vaccines with different dosages and schedules among healthy young adults in China: A 2-year follow-up study.

机构信息

a Department of Microbiology and Center of Infectious Diseases , School of Basic Medical Sciences, Peking University Health Science Center , Beijing , China.

b Clinical Laboratory Center, Beijing Friendship Hospital, Capital Medical University , Beijing , China.

出版信息

Hum Vaccin Immunother. 2018 Jun 3;14(6):1475-1482. doi: 10.1080/21645515.2018.1438090. Epub 2018 Feb 26.

Abstract

Immunogenicity of hepatitis B vaccine between 20 μg with 3-dose schedule and 60 μg with 2-dose regimens was compared 2 years after primary immunization. A total of 353 healthy adults aged 18-25 years were enrolled in the study and randomly assigned (1: 1: 1) into 3 vaccine groups: A (20 μg, 0-1-6 month), B (60 μg, 0-1 month) and C (60 μg, 0-2 month). Serum samples were collected at 1 month after a series vaccination and 12 months, 24 months after the first-dose. The GMC level of anti-HBs antibody was measured using Chemiluminescent Microparticle ImmunoAssay (CMIA). There were 59, 45 and 55 vaccinees available to follow-up with 2 year later in vaccine groups A, B and C, respectively. No significant differences existed in sex ratio, age and body mass index (BMI) among vaccinees at month 24 and the corresponding participants at baseline in each group (P > 0.05). The seroprotection rates in group A, B and C were 98.31%, 88.37% and 85.19%, respectively (P = 0.014), reflecting the fact that the rate of group A was significantly higher than that in group C (P = 0.026). Also, the GMC level of anti-HBs antibody in group A was significantly higher than those of other two groups (427.46 mIU/ml vs. 89.74 mIU/ml, 89.80 mIU/ml, respectively; all P < 0.01). This data suggested that the standard 20 μg (0-1-6 month) regimen of hepatitis B vaccine should be recommended as a priority on the premise of complete compliance in adults.

摘要

本研究比较了 20μg 三剂方案和 60μg 两剂方案的乙型肝炎疫苗在初次免疫后 2 年的免疫原性。共纳入 353 名 18-25 岁的健康成年人,按 1:1:1 随机分为 3 组疫苗:A 组(20μg,0-1-6 月)、B 组(60μg,0-1 月)和 C 组(60μg,0-2 月)。在系列接种后 1 个月和第 1、12、24 个月采集血清样本。采用化学发光微粒子免疫分析(CMIA)检测抗-HBs 抗体的几何平均浓度(GMC)水平。A、B、C 组分别有 59、45 和 55 名接种者在接种后 2 年时进行随访。在第 24 个月时,各组间接种者的性别比例、年龄和体重指数(BMI)差异无统计学意义(P >0.05)。A、B、C 组的血清保护率分别为 98.31%、88.37%和 85.19%(P =0.014),表明 A 组的血清保护率显著高于 C 组(P =0.026)。此外,A 组的抗-HBs 抗体 GMC 水平显著高于其他两组(427.46 mIU/ml 比 89.74 mIU/ml 和 89.80 mIU/ml,均 P <0.01)。这些数据表明,在完全遵守的前提下,成人应优先推荐使用标准的 20μg(0-1-6 月)乙型肝炎疫苗方案。

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