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作者在一项大规模临床试验中对医务人员皮内接种低剂量乙型肝炎疫苗或肌肉接种标准剂量疫苗以比较两者的免疫原性。受试者是来自North Arundel医院的成年雇员和社会上的卫生保健人员。所有受试者均无任何免疫抑制病或服用免疫抑制药物、怀孕、预先接种过乙型肝炎疫苗或乙型肝炎免疫球蛋白等情况。将受试者随机分成两组,Ⅰ组皮内接种2μg疫苗,Ⅱ组肌肉接种20μg疫苗。均在三角肌区接种,程序为0、1、6月,于第1针后3、8、12和24个月采血,检测抗-HBc和抗-HBs。研究期间,肌肉接种组的抗-HBs阳转率和抗体滴度高于皮内接种组。8个月时,肌肉组抗体阳转率为92.6%,皮内组为81.0%。肌肉组抗体几何平均滴度(3649mIU/ml)显著高于皮内组(1174mIU/ml)。
In a large-scale clinical trial, the authors vaccinated medical staff with intradermal low-dose hepatitis B vaccine or intramuscular doses of standard vaccines to compare the immunogenicity of both. Subjects were adult employees from North Arundel Hospital and community health workers. All subjects had no immunosuppressive disease or immunosuppressive drugs, pregnancy, pre-vaccination of hepatitis B vaccine or hepatitis B immunoglobulin situation. Subjects were randomly assigned to two groups, Group I received 2 μg of vaccine intradermally and Group II received 20 μg of vaccine intramuscularly. All rabbits were inoculated in the deltoid area for 0, 1, and 6 months. Blood samples were taken at 3, 8, 12 and 24 months after the first stitch to detect anti-HBc and anti-HBs. During the study period, the anti-HBs positive rate and antibody titers in the muscle inoculation group were higher than those in the intradermal vaccination group. At 8 months, muscle group antibody positive rate was 92.6%, intradermal group was 81.0%. The geometric mean antibody titer of muscle group (3649 mIU / ml) was significantly higher than that of intradermal group (1174 mIU / ml).