重组酵母乙型肝炎疫苗血清学免疫效果的观察

OBSERVATION ON IMMUNE EFFECT OF YEAST-DERIVED RECOMBINANT HEPATITIS B VACCINE.

目的 :探讨国产重组酵母乙型肝炎 (乙肝 )疫苗不同剂量、不同间隔时间免疫后 4年的血清学免疫效果。方法 :对乙肝表面抗原 (HBs Ag)阳性母亲和阴性母亲的新生儿 ,按第 1针分别接种 10μg或 5μg乙肝疫苗 ,4年后观察免疫效果 ;同时对 HBs Ag阴性母亲的新生儿选择第 3针与第 1针的不同间隔时间进行接种 ,全程免疫后 4年观察免疫效果。结果 :乙肝疫苗全程免疫 4年后 ,HBs Ag阳性母亲的新生儿第 1针接种 10μg组抗 - HBs阳性率高于 5μg组 ,差别有显著性。对 HB-s Ag阴性母亲的新生儿进行免疫时 ,乙肝疫苗第 3针与第 1针间隔 5、 6、 8个月 ,其抗 - HBs阳性率及抗体水平 ,差别均无显著性。所有接种对象 ,全程免疫 4年后抗 - HBs阳性率及抗体水平均较低。结论 :HBs Ag阳性母亲的新生儿国产重组酵母乙肝疫苗第 1针 10μg组全程免疫效果优于 5μg组 ,HBs Ag阴性母亲的新生儿乙肝疫苗第 3针与第 1针间隔 5、 6、 8个月都是可行的 ,4周岁儿童乙肝疫苗加强接种是必要的。

Objective:To explore the immune effect of different dosages and intervals of domestic yeast-derived recombinant hepatitis B(rHB) vaccine 4 years after full course immunization.Methods:The infants born to HBsAg positive mothers were divided into two groups and give them 3 rHB vaccine doses of 10-5-5μg or 5-5-5μg.Simultaneity,the infants born to HBsAg negative mothers were treated in the same way but with different intervals.Results:4 years after full course immunization,the anti-HBs positive rate of the infants born to HBsAg positive mothers given 10μg at the first dose were significantly higher than that in infants given 5μg at the first dose.The anti-HBs positive rate and the GMT of the infants born to HBsAg negative mothers with 3 doses of rHB vaccine of 0,1,5,0,1,6 or 0,1,8 schedules showed no significant difference and those of all infants were all relatively low 4 years after full course immunization.Conclusion:For the infants born to HBsAg positive mothers,the immune effect of these ones given 10μg at the first dose was well than those given 5μg at the first dose.For the infants born to HBsAg negative mothers,the 0,1,5,0,1,6 or 0,1,8 immunizing schedules were all feasible and it was very necessary to booster inoculate enfant four years old with rHB vaccine.