口服轮状病毒活疫苗和麻疹-流行性腮腺炎-风疹联合减毒活疫苗同时免疫的安全性和免疫原性观察  

Safety and immunogenicity of combined immunization with live rotavirus vaccine(oral)and measles,mumps and rubella vaccine

作　　者：刘小琴 漆琪[2] 刘宇[2] 杨渊 张岷 陈海平 肖艳慧 罗林云 Liu Xiaoqin;Qi Qi;Liu Yu;Yang Yuan;Zhang Min;Chen Haiping;Xiao Yanhui;Luo Linyun(Marketing Center,China National Biotec Group Company Limited,Beijing 100029,China;Immunization Planning Department,Sichuan Provincial Center for Disease Control and Prevention,Chengdu 610044,China)

机构地区：[1]中国生物技术股份有限公司营销中心,北京100029 [2]四川省疾病预防控制中心免疫规划所,成都610044

出　　处：《中华微生物学和免疫学杂志》2022年第4期317-322,共6页Chinese Journal of Microbiology and Immunology

摘　　要：目的:评价口服轮状病毒活疫苗(轮状疫苗)和麻疹-流行性腮腺炎-风疹联合减毒活疫苗(measles, mumps and rubella vaccine, MMR)同时免疫与单独免疫其安全性和免疫原性的差异。方法:选择出生后未接种过轮状疫苗和MMR疫苗的8~9月龄儿童共1 752人,分为研究组(轮状疫苗和MMR疫苗)652人、对照组1(轮状疫苗)723人、对照组2(MMR疫苗)377人。观察接种后30 d内局部及全身不良反应;在免疫前及免疫后35~42 d采血并分离血清,检测抗体浓度。结果:研究组与对照组1、对照组2间的轮状、麻疹、风疹病毒抗体阳性率和抗体浓度差异无统计学意义( P>0.05),且免疫后的轮状、麻疹、风疹病毒抗体阳性率和抗体浓度均高于免疫前。研究组腮腺炎病毒抗体浓度高于对照组2( P<0.05),组间抗体阳性率差异无统计学意义( P>0.05),两组免疫后的腮腺炎病毒抗体阳性率和抗体浓度均高于免疫前。1 752名婴幼儿受试者中,发热不良事件总发生率为1.54%(27/1 752),腹泻不良事件总发生率为0.63%(11/1 752),同时未观察到其他异常反应、偶合反应和任何有临床意义的不良反应。 结论:单独接种及同时接种口服轮状病毒活疫苗和MMR疫苗均具有良好的免疫原性和安全性。Objective To evaluate the difference in safety and immunogenicity of live rotavirus vaccine(oral)and measles,mumps and rubella(MMR)vaccine immunized alone or in combination.Methods This study recruited 1752 children aged 8-9 months who had not been vaccinated with live rotavirus vaccine(oral)or MMR vaccine after birth.The subjects were divided into three groups:study group(652 subjects,immunized with live rotavirus vaccine and MMR vaccine),control group 1(723 subjects,immunized with live rotavirus vaccine)and control group 2(377 subjects,immunized with MMR vaccine).Local and systemic adverse reactions within 30 d after vaccination were recorded.Serum samples were collected before and 35-42 d after immunization for analyzing the changes in antibodies.Results Immunization alone or in combination with live rotavirus vaccine(oral)and MMR vaccine achieved similar results in the positive rates and concentrations of antibodies against rotavirus,measles and rubella viruses(P>0.05).Moreover,the positive rates and the concentrations of the three antibodies were increased after vaccination.Compared with the control group 2,the concentration of antibody against mumps virus in the study group was increased(P<0.05),but no significant difference in the positive rate of antibody against mumps virus was found between the two groups(P>0.05).The positive rate and the concentration of antibody against mumps virus were increased after combined immunization or immunization with MMR vaccine alone.The overall incidence of fever and diarrhea was 1.54%(27/1752)and 0.63%(11/1752).No other abnormal reactions,incidental reactions or adverse reactions of any clinical significance were observed.Conclusions Live rotavirus vaccine(oral)and MMR vaccine immunized alone or in combination showed good immunogenicity and safety.

关 键 词：轮状疫苗 麻腮风疫苗 安全性 免疫原性 

分 类 号：R186[医药卫生—流行病学]