摘要
目的评价诺华公司生产的b型流感嗜血杆菌(Haemophilus influenzae type b,Hib)结合疫苗的安全性及免疫原性。方法采用随机、对照、双盲方法,将320名2～5月龄健康婴幼儿按照1∶1的比例分为实验组和对照组,实验组接种3剂诺华公司生产的Hib结合疫苗,对照组接种3剂某进口Hib结合疫苗,每剂间隔1个月,接种部位和途径均为上臂三角肌肌肉注射。每剂接种后30 min、6 h、24 h、48 h、72 h,对观察对象进行主动安全性观察;每剂接种后4～28 d,观察对象主动报告接种疫苗后的不良反应及不良事件发生情况。分别于接种前和全程免疫后28 d采集指血,ELISA法测定Hib-PRP抗体水平,评价疫苗的免疫原性。结果实验组3针总局部反应发生率为12.67%,对照组3针总局部反应发生率为14.69%,两组差异无统计学意义(P>0.05);实验组第1针局部反应发生率明显低于对照组,而第2、3针局部反应发生率高于对照组。实验组3针总全身反应发生率为19.33%,对照组3针总全身反应发生率为22.38%,两组差异无统计学意义(P>0.05);实验组与对照组各针次全身反应发生率差异均无统计学意义(P>0.05)。实验组和对照组接种疫苗后,Hib-PRP抗体水平≥1.0μg/ml的比例分别为97.33%和95.80%,二者差异无统计学意义(P>0.05);Hib-PRP抗体水平≥0.15μg/ml的比例均为100%。实验组和对照组接种疫苗后,Hib-PRP抗体水平分别为(3.82±39.76)和(5.22±43.22)μg/ml。结论未观察到诺华公司Hib结合疫苗与某进口Hib结合疫苗的安全性和免疫原性存在差别。
Objective To evaluate the safety and immunogenicity of Haemophilus influenzae type b（Hib） conjugate vaccine manufactured by Novartis International AG.Methods A total of 320 healthy infants at ages of 2 ~ 5 months were randomly divided into trial and control groups according to a ratio of 1 ∶ 1.The infants in trial group were injected i.m.with three doses of Hib conjugate vaccine manufactured by Novartis,while those in control group with an imported Hib conjugate vaccine,each at an interval of one month.Local and systemic adverse reactions were observed 30 min,6 h,24 h,48 h and 72 h after each dose.Adverse events following immunization（AEFIs） were collected 4 ~ 28 d after each dose.Hib-PRP antibody levels in sera were determined before the first dose and 28 d after the last dose by ELISA respectively,based on which the immunogenicity of vaccine was evaluated.Results The total local adverse reaction rates were 12.67% in trial groups and 14.69% in control group,which showed no significant difference（P 0.05）.The local adverse reaction rate in trial group after the first dose was significantly lower,while those after the second and third doses were significantly higher,than those in control group.The total systemic adverse reaction rates were 19.33% in trial group and 22.38% in control group,which showed no significant difference（P 0.05）.The systemic adverse reaction rates after each dose showed no significant difference in trial and control groups（P 0.05）.The proportions of subjects with Hib-PRP antibody levels of not less than 1.0 μg / ml were 97.33% and 95.80% in trial and control groups respectively,which showed no significant difference（P 0.05）.However,both the proportions of subjects with Hib-PRP antibody level of not less than 0.15 μg / ml in two groups were 100%.The Hib-PRP antibody levels in trial and control groups were（3.82 ± 39.76） and（5.22 ± 43.22） μg / ml in trial and control groups respectively.Conclusion No differences were observed between the safety and immunogenicity of Hib conjugate vaccine manufactured by Novartis and the Hib conjugate vaccine as control.
出处
《中国生物制品学杂志》
CAS
CSCD
2013年第7期991-993,996,共4页
Chinese Journal of Biologicals
关键词
B型流感嗜血杆菌结合疫苗
安全性
免疫原性
Haemophilus influenzae type b conjugate vaccine
Safety
Immunogenicity
