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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
Objective To investigate the safety and immunogenicity of the whole cell pertussis, diphtheria, tetanus and hepatitis B vaccine developed by Wuhan Institute of Biological Products, and to explore the immunization procedure of the combined vaccine. Methods 2 clinical observation. The subjects were randomly divided into three groups, the first group in accordance with 2, 4, 6 months of age vaccination baitai broken hepatitis B (CHO) vaccine; group 2 in accordance with 3, 4, 5 months of age vaccination baibai broken hepatitis B CH0) combination vaccine; group 3 in accordance with 3, 4, 5 months of age vaccination baibai joint vaccine. The second phase of the study was also randomly divided into three groups, the first group in accordance with 2, 4, 6 months of age vaccinated “baibab the hepatitis B combination vaccine”; the second group in accordance with 2, 4, 6 months old left arm inoculation hepatitis B control vaccine, On the right arm inoculation diphtheria triple triple control vaccine. Results In the first phase of the safety trial, 91 subjects were observed, of which one in each of the two groups vaccinated with the quadruple vaccine had a weaker increase, accounting for 33% of the inoculation cases respectively. A total of 365 cases were inoculated in Phase II, and 319 cases were completed with full immunization. Among 4, 4, and 6 months vaccine groups, 4 cases had side effects with the incidence rate of 31%. According to 2, 4, and 6 months, the left arm vaccinated with hepatitis B vaccine and the right arm vaccinated with dipyridamole vaccine 5 cases of side effects occurred, the incidence of 42%; group 3 0,1,6 months of age vaccination of hepatitis B vaccine, 3, 4, 5 months of age vaccination diphtheria triple controlled vaccine, a total of 14 cases of side effects, The incidence was 12 2%. No clinical observations of stage 1 and 2 found serious side effects. Inoculation quadruple vaccine, vaccination of serum diphtheria, tetanus, hepatitis B antibody positive rate of 100%, whooping cough antibody positive rate of more than 85%, before and after immunization