不同人群接种重组(汉逊酵母)乙肝疫苗后免疫效果观察

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。

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

Objective To discuss the efficacy of immunization of a recombinant(Hansenula Polymorpha) hepatitis B vaccine in different 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(Hansenula Polymorpha) hepatitis B Vaccine was effected to these subjects at beginning,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 three 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(χ2=0.757,P=0.384).The GMC of anti-HBs was 397.66 mIU/ml in the group under 15 years and 270.80mIU/m1 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.