吸附百白破乙肝(CHO)四联疫苗接种反应及血清学效果观察

Adverse Reaction and Serological Effect of Adsorbed DTP and HB (CHO) Combined Vaccine

目的 考察百日咳、白喉、破伤风、乙肝四联疫苗的接种反应及血清学效果。方法 选择足月分娩、母亲乙肝表面抗原阴性、身体健康的新生儿为接种对象。一期观察 6 0例 ,随机分为 3组 ,第 1组按 2、4、6月龄接种四联疫苗 ;第 2组按 3、4、5月龄接种四联疫苗 ;第 3组按 3、4、5月龄接种三联疫苗。二期观察 35 0人 ,随机分为3组 ,第 1组按 2、4、6月龄接种四联疫苗 ,118人 ;第 2组按 2、4、6月龄左臂接种乙肝疫苗 ,右臂接种三联疫苗 ,114人 ;第 3组按 0、1、6月龄接种乙肝疫苗 ,3、4、5月龄接种三联疫苗 ,118人。结果 一期观察 1组、2组和 3组体温弱反应分别为 5 0 %、10 %和 2 0 % ,无中强反应和局部反应。二期观察试验组体温弱反应为 4 2 4 % ,中反应 1 6 9% ,无强反应。局部弱反应为 0 85 % ,无中、强反应。血清学检测百日咳、白喉、破伤风、乙肝阳转率均大于 90 %。结论 吸附四联疫苗具有较好的安全性 ,采用 2、4、6月龄接种程序可有效诱导产生百日咳、白喉、破伤风。

Objective To explore the adverse reaction and serological effect of whole cell DTP and HB(CHO) combined vaccine (DTP-HB vaccine).Methods Select healthy and mature newborns from HBsAg-negative mothers as eligible.In a phase Ⅰ clinical trial, 60 newborns were divided into 3 groups, 20 per group. The newborns in group 1 were inoculated with DTP-HB vaccine at ages of 2,4 and 6 months,and those in group 2 with the combined vaccine at ages of 3,4 and 5 months.However, the newborns in group 3 were inoculated with adsorbed DTP as control at ages of 3,4 and 5 months.Observe the adverse reactions of the newborns in all the 3 groups. In a phase Ⅱ clinical trial,350 newborns were divided into 3 groups randomly.The 118 newborns in group 1 were inoculated with DTP-HB vaccine at ages of 2,4 and 6 months, and the 114 newborns in group 2 with HB and DTP vaccines in left and right arms respectively, at ages of 2,4 and 6 months. However, the 118 newborns in group 3 were inoculated with HB vaccine at ages of 0,1 and 6 months and DTP vaccine at 3,4 and 5 months.Observe the adverse reactions and serological effect in the newborns of the 3 groups.Results In the phase Ⅰ clinical trial, mild systemic reactions were observed in 5%,10% and 20% of newborns in groups 1, 2 and 3 respectively, but no local, moderate or strong systemic reactions. In the phase Ⅱ clinical trial,mild and moderate systemic reactions were observed in 4.24% and 1.69% of newborns in group 1(test group) respectively.Mild local reactions were observed in 0.85% of the newborns, but no moderate or strong local reactions. All the positive conversion rates of pertussis, diphtheria, tetanus and HB antibodies of newborns in test group were more than 90%.Conclusion The adsorbed whole cell DTP-HB vaccine was safe. The combined vaccine inoculated at ages of 2,4 and 6 months induced protective antibodies against pertussis, diphtheria, tetanus and HB.