无细胞百白破b型流感嗜血杆菌联合疫苗不同部位接种安全性及免疫原性评价  

Immunogenicity and safety of DTaP/Hib combined vaccination at different inoculation sites among infants

作　　者：刘振江 吴春敏[1] 黄家梅 叶素贞 吴惠华 周翔[2] 李贵凡[3] 陈萍 张浩 胡凤清 LIU Zhen-jiang;WU Chun-min;HUANG Jia-mei(Teaching Base of Public Health School of Fujian Medical University,Nanping Municipal Center for Disease Control and Prevention,Nanping,Fujian Province 353001,China)

机构地区：[1]福建省南平市疾病预防控制中心福建医科大学公共卫生学院教学基地,福建南平353001 [2]南平市延平区疾病预防控制中心 [3]北京民海生物科技有限公司

出　　处：《中国公共卫生》2022年第2期177-180,共4页Chinese Journal of Public Health

摘　　要：目的评价无细胞百白破b型流感嗜血杆菌联合疫苗(DTaP/Hib)不同部位接种后的安全性和免疫原性。方法2015年9月—2016年3月在福建省南平市选择3月龄婴儿入组164名,于3、4、5月龄共接种3剂次针次DTaP/Hib疫苗。接种疫苗后对所有受试者进行不良反应的随访观察,并采集受试者免疫前和基础免疫后28 d的血清样本,进行免疫原性观察。结果不同接种部位接种DTaP/Hib疫苗后受试者不良反应发生率均较低,且无显著性差异。除白喉抗体的几何平均增长倍数(GMI)大腿组高于臀部组外,其余抗体的阳性率、阳转率、几何平均浓度(GMC)、GMI组间比较,差异均无统计学意义。结论上臂三角肌、大腿前外侧和臀部均可以作为接种部位,接种部位不同不影响DTaP/Hib疫苗的安全性和免疫原性。Objective To evaluate the immunogenicity and safety of a diphtheria-tetanus-acellular pertussis and Haemophilus influenzae type b(DTaP/Hib)combined vaccination at different inoculation sites.Methods From September 2015 to March 2016 in Nanping city of Fujian province,China,a total of 164 infants aged 3 months were enrolled and assigned into three groups randomly for inoculations with 3 doses of the DTaP/Hib combined vaccine at 3-,4-,and 5-month of age at three injection sites including deltoid muscle of upper arm,anterolateral thigh muscle and gluteal muscle.Follow-up observations on adverse effects after each dose of the vaccinations were conducted among all the infants and blood samples were collected before the first dose and 28 days after basic immunization for the detection on immunogenicity.Results The incidence of adverse reactions was low after inoculations of DTaP/Hib combined vaccine at the three different injection sites,and there was no significant difference in the incidence among the infants of the three groups;there were also no significant disparities in positive rate,seroconversion rate,geometric mean concentration and geometric mean increase(GMI)for antibodies among the three groups,except for an observed higher GMI of diphtheria antibody in the infants with the injections into anterolateral thigh muscle than that in the infants with the injections into gluteal muscle.Conclusion Deltoid muscle of upper arm,anterolateral thigh muscle and gluteal muscle all could be used as injection sites for the inoculation of DTaP/Hib combined vaccine and the injection sites do not affect the immunogenicity and safety of the vaccine.

关 键 词：DTaP/Hib 联合疫苗 注射部位 安全性 免疫原性 

分 类 号：R186[医药卫生—流行病学]