SARS-CoV-2灭活疫苗(Vero细胞)在≥60岁高血压和(/或)糖尿病人群中的安全性及免疫原性评价

Safety and immunogenicity of SARS-CoV-2 inactivated vaccine(Vero cells)in people aged 60 and above with hypertension and/or diabetes

目的评价≥60岁高血压和(/或)糖尿病人群接种严重急性呼吸综合征冠状病毒2(severe acute respiratory symptom coronavirus 2,SARS-CoV-2)灭活疫苗(Vero细胞)后的安全性和免疫原性。方法于贵州省松桃苗族自治县选择≥60岁高血压、糖尿病患者及健康人群为研究对象,分为高血压组、糖尿病组、合并疾病组(同时患高血压与糖尿病)、健康人群对照组,分别于0、21 d经上臂外侧三角肌肌内注射SARS-CoV-2灭活疫苗(Vero细胞),接种剂量为0.5 mL。记录免疫后≤30 min、0~7 d、8~21 d时间段的不良事件,并随访至接种后6个月。分别于疫苗接种前及接种后28 d,采集受试者静脉血5.0 mL,分离血清,采用细胞病变法检测中和抗体水平,并计算中和抗体几何平均滴度(geometric mean titers,GMT)及抗体阳转率。高血压组及疾病合并组患者分别于每剂接种前、接种后30 min及1~7 d固定时间测量血压;糖尿病组及疾病合并组患者分别于每剂接种前测量1次空腹血糖,接种后当天测量1次餐后2 h血糖,接种后1、3、5、7 d分别检测空腹和餐后2 h血糖。结果高血压组、糖尿病组、合并疾病组、健康人群对照组征集性不良事件发生率差异无统计学意义(χ^(2)=1.790,P=0.617);非征集性不良事件的发生率差异无统计学意义(P=0.412)。共发生5例严重不良事件,经判定均与疫苗无关。血压和血糖测定值未见异常波动。高血压组、糖尿病组和合并疾病组率差的95%CI的下限均>-10%,中和抗体GMT率比的95%CI下限均>0.67,均非劣效于健康人群对照组。结论≥60岁高血压和(/或)糖尿病人群接种SARS-CoV-2灭活疫苗(Vero细胞)后具有良好的安全性和免疫原性。

Objective To evaluate the safety and immunogenicity of SARS-CoV-2 inactivated vaccine(Vero cells)for people aged 60 and above with hypertension and/or diabetes.Methods In Songtao Miao Autonomous County,Guizhou Province,hypertensive and diabetic patients aged 60 and above and healthy people were selected as the research objects.They were divided into hypertension group,diabetes group,combined disease group(suffering from hypertension and diabetes simultaneously)and healthy people control group,and injected intramuscularly with SARS-CoV-2 inactivated vaccine(Vero cells)through the lateral deltoid muscle of upper arm at 0 and 21 d respectively,with a dose of 0.5 mL each time.Adverse events in≤30 min,0~7 d and 8~21 d after immunization were recorded and followed up to 6 months after vaccination.Venous blood samples of 5.0 mL were collected before vaccination and 28 d after vaccination.The sera were separated,detected for neutralizing antibody levels by cytopathic assay and calculated for the geometric mean titers(GMTs)of neutralizing antibody and antibody seroconversion rate.Blood pressure of patients was measured in fixed time before vaccination and 30 min and 1~7 d after vaccination in hypertension group and combined disease group respectively;The fasting blood glucose was measured before vaccination and 2 h postprandial blood glucose was measured once on the day of vaccination.The fasting blood glucose and 2 h postprandial blood glucose were measured on 1,3,5 and 7 d after vaccination respectively.Results There was no significant difference in the incidence of solicited adverse events among hypertension group,diabetes group,combined disease group and healthy control group(χ^(2)=1.790,P=0.617);There was no significant difference in the incidence of non-solicitation adverse events(P=0.412).A total of 5 serious adverse events occurred,all of which were judged to be unrelated to vaccines.No abnormal fluctuation of blood pressure and blood glucose was observed.The lower limits of 95%CI of the rate difference of hypertension,diabetes and combined disease groups were all greater than-10%,and the lower limits of 95%CI of the neutralizing antibody GMT ratio were greater than 0.67,all of which were not inferior to the healthy control group.Conclusion SARS-CoV-2 inactivated vaccine(Vero cells)has good safety and immunogenicity for people aged 60 and above with hypertension and/or diabetes.