不同种类与剂量乙型肝炎疫苗在青年中的免疫效果及安全性

Immune effect and safety of various kinds of hepatitis B vaccine at various dosages in adolescents

目的 探讨不同种类与剂量乙型肝炎疫苗在青年中的免疫效果及安全性。方法 在江西省上饶市卫生学校抽取乙型肝炎表面抗原（hepatitis B surface antigen,HBsAg）阴性、健康状况良好的15～20岁学生910名,随机分为A、B、C 3组,按照0、1、6月免疫程序,分别经上臂外侧三角肌全程接种3针10μg/ml重组乙型肝炎疫苗（CHO细胞）、20μg/ml重组乙型肝炎疫苗（CHO细胞）和10μg/ml重组乙型肝炎疫苗（酵母）,全程免疫后1个月采集接种者静脉血,分离血清,采用放射免疫法检测抗-HBs水平,并进行安全性观察。结果 全程免疫后1个月,A组与C组抗体阳转率、抗-HBs GMC水平和分布相近,差异均无统计学意义（P〉0.05）;B组的抗体阳转率、抗-HBs GMC水平和逸500 mIU/ml的分布均明显高于A组和C组（P均〈0.01）,抗-HBs GMC﹤10和10～499 mIU/ml的分布显著低于A组和C组（P〈0.01或〈0.001）。有1名接种者在接种后0.5 h有局部疼痛症状,第2天疼痛消失,未见其他局部及全身不良反应。结论 接种高剂量乙肝疫苗的抗-HBs阳转率和抗-HBs GMC水平均高于低剂量乙肝疫苗,提示青年应接种高剂量乙肝疫苗,以建立有效的防御乙肝的免疫屏障。

Objective To investigate the immune effect and safety of various kinds of hepatitis B （HB） vaccine at vari- ous dosages in adolescents. Methods A total of 910 healthy students at ages of 15 - 20 years in Shangrao City, Jiangxi Province, China, negative for hepatitis B surface antigen （HBsAg）, were randomly divided into groups A, B and C, and injected with three doses of 10 μg / ml recombinant HB vaccine （ CHO cells）, 20μg / ml recombinant HB vaccine （CHO cells） and 10 μg/ml recombinant HB vaccine （yeast） according to the schedule of 0, 1 and 6 month, respectively. Venous blood samples were collected one month after the last dose, from which sera were separated and determined for anti- HBs by radioimmunosaasy. Meanwhile, the safeties of vaccines were observed. Results One month after the 3rd dose, no significant differences were observed between the antibody positive conversion rates as well as GMCs and distributions of anti-HBs in groups A and C （P 〉 0. 05）. However, the antibody positive conversion rate, GMC of anti-HBs and distri- bution rate of anti-HBs at GMCs of not less than 500 mIU/ml in group B were significantly higher （each P 〈 0. 01 ）, while the distribution rates of anti-HBs at GMCs of less than 10 mIU/ml and 10 - 499 mIU/ml were significantly lower, than those in groups A and C （P 〈 0. 01 or P 〈 0. 001 ）. Local pain was observed in one student 0. 5 h after injection, which disappeared one day later. No other local or systemic adverse reactions were observed. Conclusion Both anti-HBs positive conversion rate and GMC induced by HB vaccines at high dosages were higher than those at low dosages, indicating that adolescents should he immunized with HB vaccine at high dosage to establish an effective immune barrier against HB.