2～59岁健康人群接种ACYW135群脑膜炎球菌多糖疫苗的免疫原性观察

Immunogenicity of Meningococcal groups ACYW135 polysaccharide vaccine inoculated in healthy population of age 2-59 years old

目的评价ACYW135群脑膜炎球菌多糖疫苗在2～59岁健康人群中的免疫原性。方法 2～59岁健康人群接种者随机抽样(n=60),接种一剂四价脑膜炎球菌多糖疫苗。采集接种前和接种后1个月血清,采用体外杀菌试验(Serum bactericidal assay,SBA)检测血清中抗A、C、Y、W135群脑膜炎球菌的血清杀菌滴度。结果免疫前、后血清抗A群脑膜炎球菌的血清杀菌滴度GMTs(95%CI)分别为1241(736,2091)和7559(5520,10351)(P<0.05);抗C群脑膜炎球菌的血清杀菌滴度GMTs(95%CI)分别为4(9,21)和4787(2947,7775)(P<0.05);抗W135群脑膜炎球菌的血清杀菌滴度GMTs(95%CI)分别为16(9,28)和368(162,883)(P<0.05);抗Y群脑膜炎球菌的血清杀菌滴度GMTs(95%CI)分别为120(58,246)和1373(687,2745)(P<0.05)。免疫前和免疫后血清抗A群脑膜炎球菌的杀菌滴度≥128的比例分别为87(77.4,95.1)%和100(83.2,100)%;抗C群脑膜炎球菌的比例分别为17(8.3,28.5)%和97(88.5,99.6)%;抗W135群脑膜炎球菌的比例分别为13(5.9,24.6)%和68(55.0,79.7)%;抗Y群脑膜炎球菌的比例分别为57(43.2,69.4)%和85(73.4,92.9)%。免疫后较免疫前抗A群、C群、W135群和Y群脑膜炎球菌杀菌抗体滴度≥4倍升高的比例分别为50(27.2,72.8)%、97(88.5,99.6)%、62(43.2,73.9)%和55(41.6,67.9)%。结论虽然免疫前人群由于地方和国家免疫计划的实施已具有较高水平的抗A群脑膜炎球菌的血清杀菌滴度,但接种ACYW135群脑膜炎球菌多糖疫苗后可以使其保护水平进一步提高,并使人群对C群、W135群和Y群脑膜炎球菌的低水平杀菌抗体滴度均显著升高达到保护水平,证明ACYW135群脑膜炎球菌多糖疫苗在2～59岁健康人群中具有比较好的免疫原性。

Objective To evaluate the immunogenicity of Meningococcal groups AC Y W135 polysacchafide vaccine among healthy population of age 2-59 years. Methods 60 healthy subjects randomly selected among residents of age 2-59 years in China were vaccinated one dose of Meningococcal groups ACYW135 polysaccharide vaccine. Sera were collected before and one month after the vaccination, respectively. Bactericidal titers against Meningococcal target bacteria for each serotype were generated by serum bactericidal assay （SBA）. Results GMTs （95% CI ） of pre and post vaccination were 1241 （ 736, 2091 ） and 7559 （ 5520,10351 ） for group A （ P〈0.05 ） ,4 （ 9, 21 ） and 4787 （ 2947, 7775 ） for group C （ P〈0. 05 ） ;16（9,28） and 368（162, 883） for group W135 （P〈0. 05）; 120 （ 58, 246 ） 和 1373 （ 687,2745 ） for group Y （ P〈0. 05 ）. Proportion of subjects with titer 〉I 128 of pre and post vaccination were 87 （ 77.4, 95.1 ） % and 100 （ 83.2,100 ） % for group A （P〈0.05）,17（8.3,28.5）% and 97（88.5,99.6） % for group C （P〈0.05）, 13（5.9,24.6）% and 68（55.0,79.7） % for group W135 （P〈0.05）,57 （43.2, 69.4） % and 85 （ 73.4, 92.9 ） % for group Y （ P〈0.05 ）. Proportion of subjects with four-fold increase of titer post vaccination for group ACW135Y was 50 127.2, 72.8 ） %, 97 （ 88.5, 99.6） %, 62 （ 43. 2, 73, 9 ） % and 55 （ 41.6, 67.9） %, respectively. Coneluslons It was by vaccination with Meningococcal groups ACYW135 polysaecharide vaccine that dramatically elicited immune response to group CI W135 and Y, as well as significantly enhanced pre-existing high level of GMTs against group A induced due to implementation of local and national immunization program for group A in childhood, which showed a high immunogenicity of Meningocoeeal groups ACYW135 polysaceharide vaccine in population of age 2 - 59 years.