麻疹—风疹联合疫苗、麻疹—腮腺炎—风疹联合疫苗儿童初免安全性及免疫学效果观察

发布时间：2019-06-03 04:50

【摘要】：背景 2007年,我国实施扩大的免疫规划,在原有的“6种疫苗预防7种传染病”的基础上,新增加了麻疹-风疹联合减毒活疫苗(Measles-rubella Combined Attenualed Live Vaccine, MR)、麻疹-流行性腮腺炎-风疹联合减毒活疫苗(Measles, Mumps and Rubella Combined Attenualed Live Vaccine, MMR)等,预防传染病的种类也随之增加。其中,MR联合减毒活疫苗在儿童8月龄接种,MMR联合减毒活疫苗在儿童18-24月龄接种。为了进一步了解MR联合减毒活疫苗和MMR联合减毒活疫苗在儿童8月龄起初始免疫安全性及免疫学效果,对该两种疫苗做进一步观察。目的观察MR联合减毒活疫苗、MMR联合减毒活疫苗儿童初始免疫安全性及免疫学效果,为国家免疫规划疫苗免疫程序的应用提供直接的基础数据。方法根据研究需要,选择8-18月龄未接种过含麻疹、风疹和腮腺炎成分疫苗,并未患过出疹性疾病和腮腺炎的儿童,分为MR联合减毒活疫苗组、MMR联合减毒活疫苗组,对儿童进行个案调查,同时利用常规免疫接种的机会,在上臂三角肌皮下接种MR联合减毒活疫苗组或MMR联合减毒活疫苗组,分别在接种疫苗前和接种疫苗一个月后采集儿童免疫前、后血标本。在接种疫苗后30分钟内、3天、7天和第二次采血时观察不良反应发生情况。采集的血标本经过离心后,对免疫前、后血清采用酶联免疫吸附试验(Enzyme Linked Immunosorbent Assays, ELISA)方法检测麻疹、风疹、腮腺炎IgG抗体,分析两种疫苗接种后疫苗相应成分抗体阳转情况。同时,在接种疫苗后对儿童进行随访,观察疫苗接种后不良反应发生情况。麻疹、风疹、腮腺炎抗体分别选用德国“维润赛润”麻疹、风疹和腮腺炎IgG抗体检测试剂盒。结果判断标准：麻疹IgG抗体≥150mIU/ml(毫国际单位/毫升)为阳性、＜150mIU/ml为阴性；风疹IgG抗体≥10IU/ml(国际单位/毫升)为阳性、10IU/ml为阴性；腮腺炎IgG抗体≥70U/ml(单位/毫升)为阳性、70U/ml为阴性。不良反应观察观察标准见附录5。结果 MR联合减毒活疫苗组：接种疫苗前采集血标本儿童140名,接种疫苗前麻疹抗体阳性率1.43%、风疹抗体阳性率17.14%；疫苗接种后采集血标本儿童118名,麻疹抗体阳性率94.92%、风疹抗体阳性率72.03%；麻疹抗体阳转率94.83%、风疹抗体阳转率73.47%；该组不良反应发生率7.14%。 MMR组：疫苗接种前采集血标本儿童143名,疫苗接种前麻疹抗体阳性率13.29%、风疹抗体阳性率14.68%、腮腺炎抗体阳转率17.48%；疫苗接种后采集血标本儿童139名,麻疹抗体阳性率99.28%、风疹抗体阳性率84.89%、腮腺炎抗体阳性率67.62%；麻疹抗体阳转率99.18%、风疹抗体阳转率84.03%、腮腺炎抗体阳转率68.96%；该组不良反应发生率6.63%。结论 MR联合减毒活疫苗麻疹成分具有良好的免疫原性。风疹成分抗体阳转率较低,尚需进一步研究。接种MR联合减毒活疫苗未发现严重不良反应,相对安全。 MMR联合减毒活疫苗麻疹成分具有良好的免疫原性。风疹、腮腺炎成分阳转率较低,尚需进一步研究。接种MMR联合减毒活疫苗未发现严重不良反应,相对安全。
[Abstract]:background In 2007, our country implemented the expanded immunization program, on the basis of the original "Six vaccines for the prevention of 7 infectious diseases", a new combination of measles-rubella combined and attenuated live vaccine (MR), measles-mumps-rubella combined and attenuated live vaccine (Measles, Mumps and Rubella combined attached Live Vaccin) was added. e, MMR) and the like, and the types of prevention of infectious diseases also increase wherein, the MR combined attenuated live vaccine is inoculated at the age of 8 months, and the MMR and the attenuated live vaccine are taken at the age of 18 to 24 months of the child in ord to further understand that initial immunization safety and the immunological effect of the combined attenuated live vaccine and the MMR vaccine in the age of 8 months of the child, the two vaccines are further A. Objective To observe the initial immunization safety and immunological effect of the combined attenuated live attenuated live vaccine (MMR) and the attenuated live attenuated live vaccine (MMR) in children, and provide a direct and direct method for the application of the vaccine to the national immunization program. basis The method comprises the following steps of: selecting a vaccine containing measles, rubella and mumps in 8-18 months of age according to the needs of the research, and is not affected by the measles, rubella and mumps, and is divided into a combination of the MR and the attenuated live vaccine, the MMR and the attenuated live vaccine group, A case-by-case study was conducted on children, with the opportunity to use conventional immunizations, and a combination of a combination of an attenuated live vaccine or a combination of MMR and an attenuated live vaccine was administered subcutaneously in the upper arm's deltoid muscle, which was collected one month before and after the vaccination. Blood samples before and after immunization,3 days,7 days, and second time of blood collection within 30 minutes of the administration of the vaccine An enzyme-linked immunosorbent assay (ELISA) was used to detect the measles, rubella and mumps IgG antibody, and the vaccine phase after vaccination was analyzed by enzyme-linked immunosorbent assay (ELISA). In addition, after vaccination, the child will be followed up to observe the vaccination The following adverse reactions occurred: Measles, rubella, and mumps were selected from German "Wei Runrun" measles, rubella and parotid. The test kit for the detection of the anti-inflammatory IgG antibody. The result is as follows: the measles IgG antibody is positive for 150 mIU/ ml (mIU/ ml), less than 150 mIU/ ml is negative, the rubella IgG antibody is 10 IU/ ml (the international unit/ ml) is positive,10 IU/ ml is negative, and the mumps IgG antibody is 70U/ ml (unit/ ml) as the male. Sex,70 U/ ml is negative. Adverse reaction view of view Results: The positive rate of measles antibody was 1.43%, the positive rate of rubella antibody was 17.14%, and the positive rate of measles antibody was 94.92. The positive rate of rubella antibody was 72.03%, the positive rate of measles antibody was 94.83%, and the positive rate of rubella antibody was 73.47%. The incidence of the group was 7.14%. MMR group:143 children were collected before the vaccination, the positive rate of the measles antibody was 13.29%, the positive rate of the rubella antibody was 14.68%, the positive rate of the mumps antibody was 17.48%, and the positive rate of the measles antibody was 99. The positive rate of the rubella antibody was 84.89%, the positive rate of the mumps antibody was 67.62%, the positive rate of the measles antibody was 99.18%, the positive rate of the rubella antibody was 84.03%, and the seroconversion rate of the mumps antibody was 68.9%. 6% ; the incidence of adverse reactions in the group was 6.63%. Conclusion M the measles component of the R joint attenuated live vaccine has good immunogen, The positive rate of the antibody of rubella is lower, and it is necessary to further study. The combined attenuated live vaccine did not find serious adverse reactions and was relatively safe. The measles component of the MMR vaccine combined with the attenuated live vaccine has good immunogen Sex. Rubella and mumps are low in positive rate and need to be further studied. Inoculated M
【学位授予单位】：中国疾病预防控制中心
【学位级别】：硕士
【学位授予年份】：2010
【分类号】：R186

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