| 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].Chinese journal of Epidemiology,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 |
| Received:August 07, 2021 |
| DOI：10.3760/cma.j.cn112338-20210807-00617 |
| KeyWord: 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 |
| English Key Word: Inactivated SARS-CoV-2 vaccine Randomized controlled trial Immunogenicity Safety Public security officer Immunization schedule |
| FundProject: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 |
| Author Name | Affiliation | E-mail | | Chen Jing | Shanxi Provincial Center for Disease Control and Prevention, Taiyuan 030012, China | | | Li Xiaoqing | Shanxi Provincial Center for Disease Control and Prevention, Taiyuan 030012, China | | | Lu Xiaoxiao | School of Public Health, Shanxi Medical University, Taiyuan 030001, China | | | Xing Rongqin | Shanxi Aviation Industry Group Co., LTD, Taiyuan 030031, China | | | Li Hong | Shanxi Provincial Center for Disease Control and Prevention, Taiyuan 030012, China | | | Zhang Xiaohong | Shanxi Provincial Center for Disease Control and Prevention, Taiyuan 030012, China | | | Wei Zhiyun | Shanxi Provincial Center for Disease Control and Prevention, Taiyuan 030012, China | | | Mu Shengcai | Shanxi Provincial Center for Disease Control and Prevention, Taiyuan 030012, China | | | Feng Lizhong | Shanxi Provincial Center for Disease Control and Prevention, Taiyuan 030012, China | 1508717672@qq.com | | Wang Suping | School of Public Health, Shanxi Medical University, Taiyuan 030001, China | supingwang@sxmu.edu.cn |
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| Abstract: |
| 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。 |
| English Abstract: |
| 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. |
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