文章摘要
陈靖,李晓清,卢晓晓,邢荣琴,李虹,张晓红,魏志云,穆生财,冯立忠,王素萍.新型冠状病毒灭活疫苗不同接种间隔的免疫原性和安全性研究[J].中华流行病学杂志,2021,42(12):2077-2081
新型冠状病毒灭活疫苗不同接种间隔的免疫原性和安全性研究
A randomized controlled trial study of immunogenicity and safety of an inactivated SARS-CoV-2 vaccine in different immunization schedules
收稿日期:2021-08-07  出版日期:2021-12-16
DOI:10.3760/cma.j.cn112338-20210807-00617
中文关键词: 新型冠状病毒灭活疫苗;随机对照试验;免疫效果;安全性;公安人员;接种方案
英文关键词: Inactivated SARS-CoV-2 vaccine;Randomized controlled trial;Immunogenicity;Safety;Public security officer;Immunization schedule
基金项目:山西省“新冠肺炎”财政资助专项;重大传染性疾病防控与诊治山西省重点实验室资助
作者单位E-mail
陈靖 山西省疾病预防控制中心, 太原 030012  
李晓清 山西省疾病预防控制中心, 太原 030012  
卢晓晓 山西医科大学公共卫生学院流行病学教研室, 太原 030001  
邢荣琴 山西航空产业集团有限公司, 太原 030031  
李虹 山西省疾病预防控制中心, 太原 030012  
张晓红 山西省疾病预防控制中心, 太原 030012  
魏志云 山西省疾病预防控制中心, 太原 030012  
穆生财 山西省疾病预防控制中心, 太原 030012  
冯立忠 山西省疾病预防控制中心, 太原 030012 1508717672@qq.com 
王素萍 山西医科大学公共卫生学院流行病学教研室, 太原 030001 supingwang@sxmu.edu.cn 
摘要点击次数: 2155
全文下载次数: 679
中文摘要:
      目的 比较公安人员按不同方案(0~14 d、0~21 d、0~28 d)接种新型冠状病毒(新冠病毒)灭活疫苗的免疫原性和安全性。方法 于2021年1-2月以山西省太原市405名公安人员为研究对象,通过随机分组将其分为3组,分别按照0~14 d、0~21 d和0~28 d方案接种2剂新冠病毒灭活疫苗,采用RT-PCR检测新冠病毒核酸,活病毒微量病变法检测新冠病毒中和抗体,分析3组的新冠病毒中和抗体GMT、血清阳转率和安全性。结果 0~14 d、0~21 d和0~28 d方案组新冠病毒中和抗体血清学阳转率均为100%,其中0~21 d组[166.70(95%CI:148.30~185.10)]和0~28 d组[179.50(95%CI:156.50~202.60)]新冠病毒中和抗体水平接近(P>0.05),均明显高于0~14 d组[86.08(95%CI:72.36~99.80)](P<0.001)。3个方案组不良反应发生率分别为1.48%(2/135)、0.74%(1/136)和1.49%(2/134)(P=0.750),均为轻度不良反应。结论 公安人员按不同方案(0~14 d、0~21 d、0~28 d)接种新冠病毒灭活疫苗后均表现出较好的血清阳转率和安全性,0~21 d和0~28 d接种方案组新冠病毒中和抗体GMT高于0~14 d方案组。
英文摘要:
      Objective To compare the immunogenicity and safety of an inactivated SARS-CoV-2 vaccine used for the vaccination in public security officers with different immunization schedules. Methods From January to February, 2021, 405 public security officers in Taiyuan were randomly divided into 3 groups. Two doses of SARS-CoV-2 inactivated vaccine were injected according to the immunization schedule of 0-14 days, 0-21 days or 0-28 days, respectively. The nucleic acid of SARS-CoV-2 was detected by reverse transcription polymerase chain reaction. The neutralizing antibodies to SARS-CoV-2 were tested by microdose cytopathogenic efficiency assay of live virus. The GMT, seroconversion rate of SARS-CoV-2 neutralizing antibody and safety of the vaccine were analyzed for the 3 groups.Results The seroconversion rate of SARS-CoV-2 neutralizing antibody was 100% in all the 3 groups. The SARS-CoV-2 neutralizing antibody level of 0-21 day group[166.70 (95%CI:148.30-185.10)] was similar to that of 0-28 day group[179.50 (95%CI:156.50-202.60)] (P>0.05), significantly higher than that of 0-14 day group[86.08 (95%CI:72.36-99.80)] (P<0.001). The incidence rates of adverse reaction in the 3 groups were 1.48% (2/135), 0.74% (1/136) and 1.49% (2/134) respectively (P=0.750), all the adverse reactions were mild.Conclusions The vaccination of inactivated SARS-CoV-2 vaccine with different immunization schedules in public security officers showed good safety and high seroconversion rate, and the GMTs of SARS-CoV-2 neutralizing antibody in 0-21 day group and 0-28 day group were higher than that in 0-14 day group.
查看全文   Html全文     查看/发表评论  下载PDF阅读器
关闭