Zhang Xiaowei, Li Yifei, Dai Chunqing, Chu Yaya, Luan Chaoqi, Wang Guihong
Anqing Medical Center, The Fifth School of Clinical Medicine of Anhui Medical University, Anhui Medical University, 352 Renmin Road, Anqing, Anhui, China.
Wannan Medical College, 22 Wenchang West Road, Wuhu, Anhui, China.
Rheumatol Ther. 2024 Feb;11(1):191-200. doi: 10.1007/s40744-023-00630-5. Epub 2024 Jan 4.
The purpose of this study was to investigate whether the inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine has a similar effectiveness and safety profile in patients with rheumatic and musculoskeletal diseases (RMDs) and healthy controls (HCs).
Between August 10, 2021 and September 30, 2021, 134 HCs and 269 patients with RMDs were recruited. All participants who tested negative for COVID-19 were vaccinated with SARS-CoV-2 inactivated vaccine. Next, 150 patients with RMDs and 30 HCs infected with the SARS-CoV-2 Omicron variant within the previous 12 weeks were recruited between February 20, 2023 and March 1, 2023. Serum samples were collected from each participant, and the serum immunoglobulin G (IgG) and immunoglobulin M (IgM) antibody titers against SARS-CoV-2 were determined using a chemiluminescence assay.
No statistically significant difference was found in the titer of anti-SARS-CoV-2 IgG and IgM antibodies, or in the incidence of vaccination-related adverse events between the RMD and HC groups (P = 0.183, P = 0.903, and P = 0.27, respectively). Serum IgG titers of SARS-CoV-2 neutralizing antibodies were significantly higher in patients who received two or more doses of inactivated vaccine than in patients who were unvaccinated or had received one dose of vaccine (244.36 ± 109.79 vs. 66.20 ± 82.50; P < 0.001).
SARS-CoV-2 inactivated vaccines have similar protective effects in HCs and patients with RMDs, with an appreciable safety profile. Fully vaccinated patients with RMDs infected with the Omicron variant were able to produce effective neutralizing antibody concentrations.
本研究旨在调查灭活严重急性呼吸综合征冠状病毒2（SARS-CoV-2）疫苗在风湿性和肌肉骨骼疾病（RMD）患者和健康对照（HC）中是否具有相似的有效性和安全性。
在2021年8月10日至2021年9月30日期间，招募了134名HC和269名RMD患者。所有COVID-19检测呈阴性的参与者均接种了SARS-CoV-2灭活疫苗。接下来，在2023年2月20日至2023年3月1日期间，招募了150名在过去12周内感染了SARS-CoV-2奥密克戎变种的RMD患者和30名HC。从每位参与者采集血清样本，并使用化学发光法测定针对SARS-CoV-2的血清免疫球蛋白G（IgG）和免疫球蛋白M（IgM）抗体滴度。
RMD组和HC组之间抗SARS-CoV-2 IgG和IgM抗体滴度或疫苗接种相关不良事件的发生率没有统计学上的显著差异（分别为P = 0.183、P = 0.903和P = 0.27）。接受两剂或更多剂灭活疫苗的患者中SARS-CoV-2中和抗体的血清IgG滴度显著高于未接种疫苗或接种一剂疫苗的患者（244.36±109.79 vs. 66.20±82.50；P < 0.001）。
SARS-CoV-2灭活疫苗在HC和RMD患者中具有相似的保护作用，安全性良好。完全接种疫苗的感染奥密克戎变种的RMD患者能够产生有效的中和抗体浓度。
