Zhang Yuntao, Chen Haiping, Lv Jun, Huang Tao, Zhang Ruizhi, Zhang Dongjuan, Luo Linyun, Wei Sheng, Liu Xiaoqin, Zhang Shangxiao, Mu Qiuyue, Huang Rongdong, Huang Jiao, Xiao Yanhui, Yang Yunkai, Han Yuting, Gong Hao, Guan Qinghu, Xie Fangqin, Wang Hui, Li Liming, Yang Xiaoming
China National Biotech Group Co., Ltd., Beijing 100024, China.
Peking University Center for Public Health and Epidemic Preparedness & Response, Department of Epidemiology & Biostatistics, School of Public Health, Peking University, No. 38 Xueyuan Road, Haidian District, Beijing 100191, China.
Vaccines (Basel). 2022 Jun 25;10(7):1020. doi: 10.3390/vaccines10071020.
To evaluate the immunogenicity and safety of the COVID-19 vaccine (Vero cell), inactivated, in a population aged ≥60 years with hypertension or(/and) diabetes mellitus.
A total of 1440 participants were enrolled and divided into four groups, 330 in the hypertension group, 330 in the diabetes group, 300 in the hypertensive combined with diabetes group (combined disease group), and 480 in the healthy population group. Two doses of the COVID-19 vaccine (Vero cell), inactivated, were administered at a 21-day interval and blood samples were collected before vaccination and 28 days after the second dose to evaluate the immunogenicity. The adverse events and changes in blood pressure and blood glucose levels after vaccination were recorded.
The seroconversion rate of the COVID-19 neutralizing antibodies was 100% for all participants. The post-inoculation geometric mean titer (GMT) in the four groups of the hypertension, diabetes, combined disease, and healthy populations were 73.41, 69.93, 73.84, and 74.86, respectively. The seroconversion rates and post-vaccination GMT in the hypertension, diabetes, and combined disease groups were non-inferior to the healthy population group. The rates of vaccine-related adverse reactions were 11.93%, 14.29%, 12.50%, and 9.38%, respectively. No serious adverse events were reported during the study. No apparent abnormal fluctuations in blood pressure and blood glucose values were observed after vaccination in participants with hypertension or(/and) diabetes.
The COVID-19 vaccine (Vero cell), inactivated, showed good immunogenicity and safety in patients aged ≥60 years suffering from hypertension or(/and) diabetes mellitus.
评估新型冠状病毒灭活疫苗（Vero细胞）在≥60岁患有高血压或（和）糖尿病的人群中的免疫原性和安全性。
共纳入1440名参与者，分为四组，高血压组330人，糖尿病组330人，高血压合并糖尿病组（合并疾病组）300人，健康人群组480人。接种两剂新型冠状病毒灭活疫苗（Vero细胞），间隔21天，在接种前和第二剂接种后28天采集血样以评估免疫原性。记录接种疫苗后的不良事件以及血压和血糖水平的变化。
所有参与者新型冠状病毒中和抗体的血清转化率均为100%。高血压组、糖尿病组、合并疾病组和健康人群组接种后的几何平均滴度（GMT）分别为73.41、69.93、73.84和74.86。高血压组、糖尿病组和合并疾病组的血清转化率和接种后GMT不劣于健康人群组。疫苗相关不良反应发生率分别为11.93%、14.29%、12.50%和9.38%。研究期间未报告严重不良事件。高血压或（和）糖尿病患者接种疫苗后未观察到血压和血糖值明显异常波动。
新型冠状病毒灭活疫苗（Vero细胞）在≥60岁患有高血压或（和）糖尿病的患者中显示出良好的免疫原性和安全性。
