冻干人用狂犬疫苗接种后安全性和免疫原性结果分析
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摘要
目的评价冻干人用狂犬疫苗(人二倍体细胞)在健康人群中使用的安全性和免疫原性。方法采用盲法,随机,平行对照方法选取2组10～60岁健康志愿者人群共214人,按照0、3、7、14和28 d程序分别接受冻干人用狂犬疫苗和地鼠肾细胞人用狂犬疫苗接种,观察每针次接种后72 h内局部和全身反应并采用WHO认可的REFIT法检测0 d、7 d、14d和42 d的血清中和抗体,结果实验组104人,对照组110人,实验组全身和局部不良反应率分别为2. 30%和0. 63%,对照组全身和局部不良反应率分别为4. 18%和2. 85%。两组之间局部反应率差异有统计学意义(χ2=7. 06,P=0. 008),全身反应率差异无统计学意义(χ2=2. 81,P=0. 09),总体反应率差异有统计学意义(χ2=8. 80,P=0. 003)。194人接种5针疫苗,共采集有效标本175份,其中实验组85例,对照组90例,实验组与对照组各针次抗体阳转率之间差异无统计学意义。免疫后第7天、14天血清抗体滴度实验组高于对照组,免疫后第42天两组血清阳转率均为100%。结论两组疫苗未观察到严重反应和严重不良事件。两组不良反应多为轻微性,在48 h和内症状消失,免疫效果较好。人二倍体疫苗不良反应率更低,产生中和抗体时间更早。
Objective To evaluate the safety and immunogenicity of the freeze-dried rabies vaccine for human use( human diploid cells) in healthy people. Methods Chose blind method,random,parallel-group methods and selected 214 healthy volunteers,age from 10 to 60,according to 0,3,7,14 and 28 day immune procedure to accept freeze-dried rabies vaccine and rat renal cell rabies vaccine for human use,observed the local and systemic reaction of body after every dose vaccination within 72 h,and the REFIT method which was recognized by WHO was used to detect 0 d,7 d and 14 d,42 d of serum neutralizing antibody. Results There were 104 people in the experimental group,110 people in the control group,in the experimental group,systemic and local adverse reaction rate were 2. 3% and 0. 63% respectively,in the control group,systemic and local adverse reaction rate were 4. 18% and 2. 85%. The difference of local reaction rate between two groups was statistically significant( χ2= 7. 06,P = 0. 008),the difference of the whole body reaction rate was not statistical significant( χ2= 2. 81,P = 0. 09),the difference of the overall reaction rate was statistically significant( χ2= 8. 80,P = 0. 003).194 people were completed with 5 vaccinations,we got a total of 175 valid samples,85 samples were came from experimental group,and 90 samples were came from control group,the difference of the antibody positive seroconversion rate between two groups had no statistical significant. The day 7,day 14 after vaccination,serum antibody degrees in the experimental group was higher than that in the control group, 42 days after immunization,serum positive rate of the two groups was both 100%. Conclusion There was no severe reaction and serious adverse event observed in two groups. The adverse reactions of two groups were mild,symptoms disappeared within 48 hours. Compared with the rabies vaccine of the rat kidney cells,the human diploid rabies vaccine has lower adverse reaction and producing neutralizing antibody time earlier
Objective To evaluate the safety and immunogenicity of the freeze-dried rabies vaccine for human use( human diploid cells) in healthy people. Methods Chose blind method,random,parallel-group methods and selected 214 healthy volunteers,age from 10 to 60,according to 0,3,7,14 and 28 day immune procedure to accept freeze-dried rabies vaccine and rat renal cell rabies vaccine for human use,observed the local and systemic reaction of body after every dose vaccination within 72 h,and the REFIT method which was recognized by WHO was used to detect 0 d,7 d and 14 d,42 d of serum neutralizing antibody. Results There were 104 people in the experimental group,110 people in the control group,in the experimental group,systemic and local adverse reaction rate were 2. 3% and 0. 63% respectively,in the control group,systemic and local adverse reaction rate were 4. 18% and 2. 85%. The difference of local reaction rate between two groups was statistically significant( χ2= 7. 06,P = 0. 008),the difference of the whole body reaction rate was not statistical significant( χ2= 2. 81,P = 0. 09),the difference of the overall reaction rate was statistically significant( χ2= 8. 80,P = 0. 003).194 people were completed with 5 vaccinations,we got a total of 175 valid samples,85 samples were came from experimental group,and 90 samples were came from control group,the difference of the antibody positive seroconversion rate between two groups had no statistical significant. The day 7,day 14 after vaccination,serum antibody degrees in the experimental group was higher than that in the control group, 42 days after immunization,serum positive rate of the two groups was both 100%. Conclusion There was no severe reaction and serious adverse event observed in two groups. The adverse reactions of two groups were mild,symptoms disappeared within 48 hours. Compared with the rabies vaccine of the rat kidney cells,the human diploid rabies vaccine has lower adverse reaction and producing neutralizing antibody time earlier
引文
[1]彭文伟.传染病学[M].北京:人民卫生出版社,2004:692-695.
[2]Rabies WECO. WHO Expert Consultation on Rabies:first report[M].World Health Organization,2005.
[3]杨裕华,苏军英,崔嵩,等.狂犬病疫苗不同免疫方法的实验研究[J].现代预防医学,1996,23(3):149-151.
[4]钱瑞雨,速存芬,任桂琼,等. 1649例狂犬病疫苗免疫者的流行病学调查分析[J].中华医学与健康,2007(9):16-17.
[5]肖东楼.狂犬病防治手册[M].2版.北京:人民卫生出版社,2010.
[6]王余俊,王晓昱,石建方,等. 53例人用狂犬病无佐剂纯化疫苗接种后抗体检测结果分析[J].现代预防医学,2012,39(11):2826-2828.
[7]赵珍谊,余刚,郑艳微,等.不同年龄人群接种人用狂犬病疫苗的接种反应及免疫应答[J].中国生物制品学杂志,2012,25(10):1349-1351.
[8]WHO. WHO Technical Report Series 931,WHO expert consultation on rabies, First Report, 2005, Geneva,Switzerland.
[9]林平.狂犬疫苗免疫后血清抗体的检测结果[J].现代预防医学,2005,32(6):629-629.
[2]Rabies WECO. WHO Expert Consultation on Rabies:first report[M].World Health Organization,2005.
[3]杨裕华,苏军英,崔嵩,等.狂犬病疫苗不同免疫方法的实验研究[J].现代预防医学,1996,23(3):149-151.
[4]钱瑞雨,速存芬,任桂琼,等. 1649例狂犬病疫苗免疫者的流行病学调查分析[J].中华医学与健康,2007(9):16-17.
[5]肖东楼.狂犬病防治手册[M].2版.北京:人民卫生出版社,2010.
[6]王余俊,王晓昱,石建方,等. 53例人用狂犬病无佐剂纯化疫苗接种后抗体检测结果分析[J].现代预防医学,2012,39(11):2826-2828.
[7]赵珍谊,余刚,郑艳微,等.不同年龄人群接种人用狂犬病疫苗的接种反应及免疫应答[J].中国生物制品学杂志,2012,25(10):1349-1351.
[8]WHO. WHO Technical Report Series 931,WHO expert consultation on rabies, First Report, 2005, Geneva,Switzerland.
[9]林平.狂犬疫苗免疫后血清抗体的检测结果[J].现代预防医学,2005,32(6):629-629.