摘要
目的分析浙江省8月龄儿童同时接种麻疹风疹联合减毒活疫苗和乙型脑炎减毒活疫苗的免疫原性和安全性。方法选定浙江省两市满8月龄健康儿童,将儿童采用随机分组方法分配至麻疹风疹联合减毒活疫苗和乙型脑炎减毒活疫苗联合接种组(试验组),麻疹风疹联合减毒活疫苗单独接种组(对照组)。分别在疫苗接种前和疫苗接种后的6周采集儿童的静脉血1 ml,检测麻疹、风疹的血清中抗体浓度,评价疫苗接种前后的麻疹、风疹抗体水平;同时对联合接种的安全性进行评价。采用酶联免疫试验方法(ELISA)测定麻疹、风疹IgG抗体,分析同时接种麻疹风疹联合减毒疫苗和乙型脑炎减毒活疫苗的免疫原性和安全性。结果共纳入符合方案的研究对象504名,其中试验组和对照组均为252名。试验组两种疫苗同时接种后麻疹抗体阳性率98.41%,阳转率96.43%,抗体几何平均浓度(GMC)为1539.94 mIU/ml,疫苗接种后风疹抗体阳性率89.29%,阳转率88.49%,GMC为47.65 mIU/ml;对照组疫苗接种麻疹抗体阳性率98.02%,阳转率97.62%,GMC为1428.96 mIU/ml,疫苗接种后风疹抗体阳性率86.51%,阳转率86.11%,GMC为45.66 mIU/ml,两组间GMC差异无统计学意义,试验组疫苗接种后麻疹、风疹抗体阳性率、阳转率非劣效于对照组。对研究对象接种疫苗后开展安全性观察,均具有较高的安全性,未发现相关严重不良反应事件,以一般反应为主,且预后良好。对试验组和对照组两组间的不良反应发生率进行比较,无统计学差异。结论8月龄联合接种麻疹风疹减毒活疫苗和乙型脑炎减毒活疫苗具有良好的安全性和免疫原性。
Objective To evaluate the immunogenicity and safety of concomitant inoculation of Measles and Rubella Combined Live-attenuated Japanese encephalitis vaccine.Methods Healthy children aged 8 months in selected cities in Zhejiang Province were randomly assigned to the MR and JVE-L combined vaccination group(the experimental group),and the MR single vaccination group(the control group)was taken before the exemption and 6 weeks after the exemption.Peripheral venous blood 1 ml was used as serum antibody test for measles and rubella,and the levels of measles and rubella antibodies before and after vaccination were evaluated.The safety of combined vaccination was evaluated.Measles and rubella IgG antibodies were detected by enzyme-linked immunosorbent assay(ELISA).Data were double-entry with Epidata and statistical analysis was performed using Epi Info epidemiological statistical analysis software.Results The results showed that no severe adverse event occurred in two groups,clinical reactions in each inoculation group were mild.The seroconversion rate of measles antibody and rubella antibody were 96.43%and 88.49%in the experimental group after vaccination,the geometrical mean concentrations(GMC)of measles antibody was 1526.45 mIU/ml and the GMC of rubella antibody was 47.70 mIU/ml after concomitant inoculation;the seroconversion rate of measles antibody and rubella antibody were 97.62%and 86.11%in the control group,the GMC of Measles antibody was 1392.28 mIU/ml and the GMC of Rubella antibody was 45.72 mIU/ml after MV inoculation.No difference were detected in two groups of seroconversion rate of measles antibody and rubella antibody and GMC after vaccination.Conclusion The immunogenicity and safety is equivalent when MR and JVE-L were simultaneous inoculation.
作者
唐学雯
严睿
周洋
邓璇
何寒青
Tang Xuewen;Yan Rui;Zhou Yang;Deng Xuan;He Hanqing(Expanded Program Immunization Department of Zhejiang Provincial Center for Diseases Control and Prevention,Hangzhou 310051,China)
出处
《中华预防医学杂志》
CAS
CSCD
北大核心
2021年第7期835-839,共5页
Chinese Journal of Preventive Medicine
基金
2019年浙江省医药卫生一般研究计划科研项目(2019KY052)
关键词
麻疹疫苗
风疹疫苗
疫苗
合成
免疫原性
安全性
Measles vaccine
Rubella vaccine
Vaccines,synthetic
Immunogenicity
Safety
