【摘要】 目的　考察武汉生物制品研究所研制的全细胞百日咳、白喉、破伤风、乙肝联合疫苗的安全性和免疫原性 ,探讨联合疫苗的免疫程序。方法　进行 2期临床观察。将研究对象随机分为 3组 ,第 1组按照 2、4、6月龄接种吸附百白破乙肝 (CHO)联合疫苗 ;第 2组按照 3、4、5月龄接种吸附百白破乙肝 (CH0 )联合疫苗 ;第 3组按照 3、4、5月龄接种吸附百白破联合疫苗。 2期研究也随机分为 3组 ,第 1组按照 2、4、6月龄接种“百白破乙肝联合疫苗” ;第 2组按照 2、4、6月龄左侧上臂接种乙肝对照疫苗 ,右侧上臂接种百白破三联对照疫苗。结果　一期安全性试验观察对象 91名 ,其中接种四联疫苗的两组各有 1名体温有较弱升高 ,分别占接种例数的 3 3%。二期共接种 36 5例 ,完成全程免疫共 319例。其中四联疫苗 2 ,4 ,6月龄接种组有 4例出现副反应 ,发生率为 3 1%;按 2 ,4 ,6月龄左臂接种乙肝疫苗、右臂接种白百破三联疫苗组有 5例发生副反应 ,发生率 4 2 %;第 3组 0、1、6月龄接种乙肝对照疫苗 ,3、4、5月龄接种百白破三联对照疫苗 ,共有 14例发生副反应 ,发生率为 12 2 %。 1、2期临床观察均未发现严重副反应。接种四联疫苗后 ,接种对象血清白喉、破伤风、乙肝抗体阳转率均达 10 0 %,百日咳抗体阳转率大于 85 %,免疫前后抗更多还原

【Abstract】 Objective To investigate the safety,efficacy and immunization schedule of whole cell DTP combined with hepatitis B vaccine (CHO) produced by Wu Han National Biological Institute.Methods Two phases were included in this trial.Three groups were included in the first phase.Group 1(30) was immunized with wDTP-HBV(CHO) according to 2,4,6 month schedule;group 2(30) was immunized wDTP-HBV(CHO) according to 3,4,5 month;group 3(31) was immunized wDTP vaccine according to 3,4,5 month.Phase 2 was also divided into 3 groups.Group 1(113) was immunized with wDTP-HBV according to 2,4,6 schedule;Group 2(113) was immunized with wDTP control vaccine in upper left arm,and HBV control vaccine on the upper right arm;Group 3(101) immunized with control HBV vaccine according to 0,1,6 month and DTP control vaccine according to 3,4,5 month.Results The body temperature of 1 child in group 1 and group 2 increased weakly,the rate was 3.3% among the whole group in phase 1 trial.In phase 2 trial,there were 4 and 5 children had mild side reaction in group 1(3.1%),2(4.2%) respectively;14 children had weak side reaction in group 3,the rate was 12.2%.No serious side reaction was found in phase 1 and 2.The antibody titer of all samples collected before the first dose and after the last dose were measured,the result showed that the sero-conversion of anti-diphtheria,anti-tetanus and anti-HBV antibody were 100%,>85% for anti-pertusis antibody.The statistics analysis showed that all the antibody level of the samples before and after immunization had significant difference.The comparison of the antibody level among 3 groups showed that the new wDTP-HBV vaccine had good ability to induce effective antibody.Conclusion This study result certified that the new adsorbed whole cell DTP and HBV(CHO) combined vaccine had good safety and efficacy,and can be used for the immunization.The new 2,4,6 immunization schedule was also able to induce enough antibody level for diphtheria,pertusis,tetanus and hepatitis B virus.更多还原