Safety and immunogenicity of SARS-CoV-2 inactivated vaccine(Vero cells)in people aged 60 and above with hypertension and/or diabetes
10.13200/j.cnki.cjb.003988
- VernacularTitle: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
- Author:
CHEN Xianhong
- Publication Type:Journal Article
- From:
Chinese Journal of Biologicals
2023;36(9):1105-1110+1116
- CountryChina
- Language:Chinese
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Abstract:
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（χ2= 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.
