成人乙型肝炎疫苗无应答者大剂量再免疫效果评价

摘要:目的　探讨2种大剂量乙型肝炎（乙肝）疫苗对无应答成人再免疫的效果，为60 μg/1.0 ml乙肝疫苗的临床应用提供依据。方法　将有乙肝疫苗全程接种史、乙肝表面抗原（HBsAg）及乙肝表面抗体（抗-HBs）阴性的健康成人，根据知情同意、随机原则分为2组，1组为20 μg组，即接种3针20 μg乙肝疫苗，按“0、1、6”程序；1组为60 μg组，即接种1针60 μg乙肝疫苗。完成免疫程序后3个月内检测乙肝5项指标。结果　无应答成人再免疫后，20 μg组和60 μg组2组抗-HBs阳转率约为88%，且正常应答者，2组抗-HBs几何平均滴度（GMT）水平相近，差异无统计学意义（P＞0.05），低应答者，60 μg组抗-HBs GMT高于20 μg组（P＜0.05）。男性抗-HBs阳转率较女性低（P＜0.05），不同年龄组间抗-HBs阳转率差异无统计学意义（P＞0.05）。结论　1针60 μg/1.0 ml乙肝疫苗和3针20 μg/ml乙肝疫苗疗效相当，可根据个体实际情况选择免疫方案。

Effect evaluation on non-response adults after revaccinated with megadose hepatitis B vaccine

Abstract: Objective This work was to investigate the effects of the revaccination with megadosage of hepatitis B vaccine on non-response adults, and to provide the basis for the clinical application of 60μg/1.0ml of hepatitis B vaccine. Methods According to the principle of informed consent and random grouping, the healthy adults negative both for hepatitis B surface antigen and hepatitis B surface antibody were randomly divided into two groups. One group were inoculated with 20 μg hepatitis B vaccine according to the schedule of 0, 1 and 6 month. The other group received one dose of 60μg hepatitis B vaccine. The five indexes of hepatitis B were tested within 3 months after revaccinated. Results After revaccination, the anti-HB positive rate of the 20 μg group and 60 μg group were all about 88%. Among those with positive conversion, the level of anti-HBs Geometric Mean Titer (GMT) of two groups were similar and there was no statistically significant difference (P>0.05). Among those with low level respondence, the level of anti-HB GMT of the 60 μg group was higher than that of the 20 μg group (P<0.05). Anti-HB positive rate of males was lower than that of females (P<0.05). Anti-HB positive rate of different age groups had no statistically significant difference (P>0.05). Conclusion The efficacy of one dose hepatitis B vaccine of 60 μg/ml and three doses of 20 μg/ml vaccine was equivalent. Immune scheme was should be chosen according to individual's personal situation.