不同人群接种重组(汉逊酵母)乙肝疫苗后免疫效果观察

Observation of the immunization efficacy of Recombinant(Hansenula Polymorpha) Hepatitis B Vaccine in different populations

目的:探讨重组(汉逊酵母)乙型肝炎(乙肝)疫苗对不同人群的免疫效果。方法:在沈阳市选择未接种过乙肝疫苗、且经ELISA法检测HBsAg、抗-HBs、抗-HBc三项指标全部为阴性的109名健康人群作为本次的观察对象,按照0、1、6的免疫程序接种10 g/0.5 ml重组(汉逊酵母)乙肝疫苗,于全程免疫1个月后采血,测定血清中抗-HBs水平。结果:109名受试者全部完成了3针全程接种,未发现明显的局部和全身反应。总抗-HBs阳转率为97.25%,几何平均浓度(GMC)为324.34 mIU/ml。15岁以下和15岁以上两组人群的抗-HBs阳转率分别为95.65%和98.41%,差异无统计学(2=0.757,P=0.384)。两组人群抗-HBs几何平均浓度分别为397.66 mIU/ml和270.80 mIU/ml,经t检验,差异有统计学意义(t=2.854,P<0.005)。男女间抗-HBs阳转率和几何平均浓度差异均无统计学意义(P>0.05)。结论:重组(汉逊酵母)乙肝疫苗具有良好的安全性和免疫效果,低年龄人群产生的保护性抗体水平较高年龄组高。

Objective To discuss the efficacy of immunization of a recombinant （Hansenula Polymorpha） hepatitis B vaccine in differ- ent populations. Method We randomly selected 109 healthy subjects who had no history of hepatitis B vaccine immunization in Shenyang city. Their HBsAg,anti - HBs and anti - HBc were all negative which were detected by ELISA. An immunization at 10 g/0. 5 ml of （ Han- senula Polymorpha） hepatitis B Vaccine was effected to these subjects at beglnning,the 1st and 6th month. After a month in completing the 3rd vaccination,their serum samples were collected and the anti - HBs were detected. Results There were 109 cases which had completed all thn~ times injection. Any local or systematic severe adverse effects were not found. The total positive seroconversion rate of anti - HBs was 97.25%. The geometric mean concentration （GMC） of anti - HBs was 324. 34mIU/m1. The positive seroconversion rate of anti - HBs was 95. 65% in the group under 15 years and 98.41% in the group above 15 years,respectively. There was no statistical significance of differences between two groups in the positive seroconversion rate of anti - HBs （X2 = 0. 757, P = 0. 384 ）. The GMC of anti - HBs was 397. 66 mIU/ml in the group under 15 years and 270. 80mIU/ml in the above 15 years ,respectively. There was a statistical significance of differences between two groups in the GMC （ t = 2. 854, P = 0. 005 ）. The statistical significance of differences were not found in the positive seroconversion rates and the GMCs between male and female （ P 〉 0. 05 ）. Conclusion The recombinant （ Hansenula Polymorpha） hepatitis B vaccine is effective and safe. The protective antibodies produced from children are higher than those from adults.