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

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。

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.