关于狂犬疫苗三种不同免疫程序有效性及安全性的研究

Study on efficacy and safety of rabies vaccine by three different immunization programs

目的研究狂犬疫苗三种不同免疫程序对供血浆者抗体效价的影响,筛查可供生产用狂犬病人免疫球蛋白的最佳的免疫程序。方法根据628名献浆者所接受的免疫情况归纳为三组,第一组有215人接受WHO推荐的传统常规免疫程序,第二组有184人接受WHO推荐的211程序,第三组229人接受改良的221程序。观察每针次接种后72 h内局部和全身反应,采用ELISA方法检测抗体效价,记录接种后20,45 d的抗体效价,将效价>7 IU/ml的供血浆者作为采集高效价特免血浆的人员。结果所有接种对象均未出现严重局部及全身反应,三组程序出现局部不良反应分别为96.7%,96.2%,73.8%。全身不良反应分别为2.8%,2.2%,1.3%。抗体效价有明显差别,应用改良的221程序可产生较高的抗体。结论通过对三组的结果比较,三组免疫程序均具有安全性和有效性,应用改良的221程序产生高效价抗体的比例高,接种者痛苦小,易于接受,相对采浆过程更为有效合理。

Objective To study the effect of three immunization programs of rabies vaccine on antibody titers and to screen the best immunization program for production of the rabies vaccine.Methods According to the immunization programs,628 plasma donors were divided into three groups.The subjects received traditional WHO recommended routine immunization program（group A,n=215）,211 procedures recommended by WHO（group B,n=184）,the modified 221 program（group C,n=229）,respectively.The local and systemic reaction of plasma donors were observed within 72 h after every needle inoculation.The antibody titers were detected by ELISA.The immune responses were recorded at 20,45 d after inoculation titers.The plasma donors with titer7 IU/ml were chosen as the subjects of high titers.Results No serious local and systemic reactions occurred in all the donors.The rates of local adverse reaction were 96.7%,96.2%,73.8% in groups A,B and C,respectively.Rates of systemic adverse reactions were 2.8%,2.2%,1.3% in groups A,B and C,respectively.Antibody titers were significantly different,and the modified 221 program produced the higher antibody title.Conclusion The results suggest that the three programs are all safe and effective.The modified 221 program not only has the advantages of most highest ratio of titer antibody,the least inoculation pain,most effective and rational plasma collection process,but also it is easy to accept by inoculator.