Zagreb方案接种国产人二倍体细胞狂犬病疫苗的免疫原性观察

Immunogenicity of human diploid cell rabies vaccine vaccinated with Zagreb regimen

目的评价人二倍体细胞狂犬病疫苗(human diploid cell rabies vaccine,HDCV)在中国10~60岁健康人群中使用Zagreb(2-1-1或4针法)方案免疫的免疫原性。方法狂犬病疫苗接种按照《狂犬病暴露后预防处置工作规范(2009版)》操作,中国10~60岁常住健康人群600人,其中Zagreb组300人,Essen(1-1-1-1-1-1或5针法)组300人。Zagreb组受试者第0天左右上臂外侧三角肌各肌内(intramuscular,IM)注射1针次,第7、21天各IM注射1针次;Essen组受试者第0、3、7、14、28天于上臂外侧三角肌肌内各注射1针次。分析比较Zagreb组和Essen组首针免疫后第14天血清狂犬病病毒中和抗体(rabies virus neutralizing antibody,RVNA)阳转率和几何平均滴度(geometric mean titer,GMT),以评价Zagreb方案的免疫效果。结果首针免疫后第14天,Zagreb组和Essen组的GMT分别为19.29IU/mL(95%CI:17.27~21.71IU,mL)和22.94IU/mL(95%CI:20.53~25.63IU/mL),Zagreb组非劣效于Essen组(t=10.66,P<0.001)。首针免疫后第14天,Zagreb组和Essen组均100%获得免疫保护。结论Zagreb方案接种HDCV的免疫效果不劣于Essen方案接种的免疫效果。

Objective To evaluate the immunogenieity of human diploid cell rabies vaccine (HDCV)immunized with Zagreb regimen in healthy chinese population aged 10 to 60 year.Methods Vaccination of rabies vaccine was carried out in accordance with the Regulations on Rabies Post-exposure Prophylaxis (2009 Version).Total 600 healthy subjects aged 10 to 60year were involved,300 subjects in Zagreb group and 300 subjects in Essen group.Zagreb group was subjected to 2-1-1 immunization procedure.The first needle was injected on 0 day with each dose vaccinated in the bilateral deltoid muscle of upper arms,and one dose was injected on the 7 th and 21st day.Essen group was immunized with 1-1-1-1-1immunization procedure,vaccinated in the lateral deltoid muscle on the 0,3rd, 7th,14th,and 28th day with one dose,respectively.The serum conversion rate and geometric mean titer (GMT)of rabies virus neutralizing antibody (RVNA)on the 14th day after the initial injection were analyzed to evaluate the immunogenicity vaccinated with Zagreb regimen.Results On the 14th day after the first needle,GMT of RVNA in Zagreb group was 19.29(95%CI:17.27-21.71)and GMT of RVNA in Essen group was 22.94(95%CI:20.53-25.63). The result of Zagreb group was not inferior to that of Essen group (t =10.66,P <0.001).The serum conversion rates on the 14th day after initial injection were 100%in Zagreb and Essen groups.Conclusions The immunogenieity of Zagreb regimen is not inferior to that of Essen regimen for HDCV.