论文部分内容阅读
为评价国产重组 (酵母 )乙型肝炎 (乙肝 )疫苗 (YDV)与国产血源乙肝疫苗 (PDV)的免疫效果和抗体持久性 ,从YDV上市后不久 ,即采用队列研究的方法 ,按照常规免疫的程序和剂量 ,建立了接种YDV和PDV两种疫苗的研究队列 ,并对两个队列进行了长达 8年的跟踪研究 ( 1994～ 2 0 0 2年 )。对两种疫苗的免疫效果、有效保护水平及抗体持久性进行了血清学研究和比较 ,结果表明 :在接种疫苗 8年后 ,两种疫苗的有效保护水平大致相近 ,平均抗体滴度都维持在保护水平以上。虽然PDV的平均抗体水平为 2 6mIU/ml,YDV的平均抗体水平为 19mIU/ml,差异有非常显著的统计学意义 (t=5 14 ,P <0 0 0 1)。但YDV的免疫剂量为 5 μg/ml/人 ,而PDV的免疫剂量却为10 μg/ml/人 ,是YDV的 2倍。提示YDV的免疫效果及抗体持久性至少可维持 8年 ,PDV至少可维持 9年。如能适当增加YDV的免疫剂量 ,可能会产生更为理想的效果。
To evaluate the immune effect and antibody durability of the domestic recombinant (yeast) Hepatitis B (hepatitis B) vaccine (YDV) and domestic blood-borne hepatitis B vaccine (PDV), a cohort study was conducted shortly after the listing of YDV, And established a study cohort to vaccinate both the YDV and PDV vaccines. The two cohorts were followed up for 8 years (1994 to 2002). Serological studies and comparisons of the immunization efficacy, the level of protection and the persistence of antibodies against the two vaccines showed that the effective levels of protection of the two vaccines were similar after 8 years of vaccination, with mean antibody titers maintained at Protection level above. Although the average antibody level of PDV was 26mIU / ml and the average antibody level of YDV was 19mIU / ml, the difference was statistically significant (t = 5 14, P <0.01). However, the immunization dose of YDV was 5 μg / ml / person, while the PDV dose was 10 μg / ml / person, which is twice of that of YDV. The results suggest that the immune effect and antibody persistence of YDV can be maintained for at least 8 years and PDV for at least 9 years. If appropriate to increase the YDV immunization dose, may produce more desirable results.