重组酵母乙型肝炎疫苗血清学免疫效果观察

Studies on Immune Effect of Yeast-derived Recombinant Hepatitis B Vaccine

为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的安全性和血清学免疫效果 ,在五总乡和兴东镇对乙肝表面抗原 (HBsAg)阳性母亲和阴性母亲的新生儿 ,按第 1针分别接种 10 μg或 5 μg乙肝疫苗 ,1个月后接种第 2针 (0 5 μg) ,第 3针 (0 5 μg)与第 1针分别间隔 5、6、8个月 ,观察免疫效果。结果显示 ,所有接种对象均未发现严重副反应。完成 3针乙肝疫苗免疫后 ,HBsAg阴性母亲的新生儿第 1针接种 10 μg组抗 -HBs阳转率及抗体水平均高于 5 μg组 ,差别均有极显著的统计学意义。第 3针乙肝疫苗与第 3针百白破混合制剂 (DPT)联合免疫 ,乙肝疫苗的免疫效果良好 ,DPT的免疫应答率及水平与非联合免疫的差别无显著的统计学意义。这表明国产重组酵母乙肝疫苗的安全性好 ,第 1针 10 μg组免疫效果优于 5 μg组 ,与DPT的联合免疫是可行的。

The safety and immune effect of different dosages and intervals of domestic yeast derived recombinant hepatitis B (rHB) vaccine were studied during the time of Dec.1988～Feb. 2000.88 infants born to HBsAg negative mothers were divided into two groups and gave them 3 rHB vaccine doses of 10-5-5μg respectively with a 0,1,6 schedule. 40 infants born to HBsAg positive mothers were treated in the same way. After full course immunization, the anti-HBs positive seroconversion rate and the GMT of the infants born to HBsAg negative mothers given 10μg rHB vaccine at the first dose were significantly higher than that in infants given 5μg at the first dose. These two indexs in infants born to HBsAg positive mothers given 10μg and 5μg respectively at first dose showed no significant difference statistically, but the HBsAg positive rate in 10μg group was 5.56% and in 5μg group was 13.64%, this indicated infants born to HBsAg positive mothers could not be well protected by increasing rHB vaccine dosage, they may be benefitted by adding injection of immunoglobulin. 3 doses of rHB vaccine of 5-5-5μg with different immunizing schedules of 0,1,5,0,1,6 and 0,1,8 months given to another number of infants born to HBsAg negative mothers showed no significant difference in anti-HBs positive seroconversion rate. A combined immunization of the third dose of rHB vaccine to infants of 5 months old together with DPT were injected simutaneously at different body sites, either the immune effect of rHB vaccine or immune response of DPT were not affected. The infants in this study receiving rHB vaccine did not have severe adverse reactions.