CoronaVac, an inactivated SARS-CoV-2 vaccine, has been approved for emergency use in several countries. However, its immunogenicity in immunocompromised individuals has not been well established. We initiated a prospective phase 4 controlled trial (no. NCT04754698, CoronavRheum) in 910 adults with autoimmune rheumatic diseases (ARD) and 182 age- and sex-frequency-matched healthy adults (control group, CG), who received two doses of CoronaVac. The primary outcomes were reduction of ≥15% in both anti-SARS-CoV-2 IgG seroconversion (SC) and neutralizing antibody (NAb) positivity 6 weeks (day 69 (D69)) after the second dose in the ARD group compared with that in the CG. Secondary outcomes were IgG SC and NAb positivity at D28, IgG titers and neutralizing activity at D28 and D69 and vaccine safety. Prespecified endpoints were met, with lower anti-SARS-Cov-2 IgG SC (70.4 versus 95.5%, P < 0.001) and NAb positivity (56.3 versus 79.3%, P < 0.001) at D69 in the ARD group than in the CG. Moreover, IgG titers (12.1 versus 29.7, P < 0.001) and median neutralization activity (58.7 versus 64.5%, P = 0.013) were also lower at D69 in patients with ARD. At D28, patients with ARD presented with lower IgG frequency (18.7 versus 34.6%, P < 0.001) and NAb positivity (20.6 versus 36.3%, P < 0.001) than that of the CG. There were no moderate/severe adverse events. These data support the use of CoronaVac in patients with ARD, suggesting reduced but acceptable short-term immunogenicity. The trial is still ongoing to evaluate the long-term effectiveness/immunogenicity.

CoronaVac 是一种灭活的 SARS-CoV-2 疫苗，已获准在多个国家紧急使用。然而，其在免疫功能低下个体中的免疫原性尚未确定。我们在 910 名患有自身免疫性风湿病 (ARD) 的成年人和 182 名年龄和性别频率匹配的健康成年人（对照组，CG）中启动了一项前瞻性 4 期对照试验（编号 NCT04754698，CoronaVRheum），他们接受了两剂 CoronaVac . 主要结果是与 ARD 组相比，ARD 组在第二次给药后 6 周（第 69 天（D69））抗 SARS-CoV-2 IgG 血清转化（SC）和中和抗体（NAb）阳性均降低 ≥ 15%在CG中。次要结果是 D28 时的 IgG SC 和 NAb 阳性、D28 和 D69 时的 IgG 滴度和中和活性以及疫苗安全性。达到了预先指定的终点，P  < 0.001) 和 NAb 阳性率（56.3 对 79.3%，P  < 0.001）与 CG 相比，ARD 组在 D69。 此外， ARD 患者的IgG 滴度（12.1 对 29.7，P  < 0.001）和中和活性中值（58.7 对 64.5%，P = 0.013）也较低。在 D28，ARD 患者的 IgG 频率（18.7 对 34.6%，P  < 0.001）和 NAb 阳性（20.6 对 36.3%，P  < 0.001）低于 CG。没有中度/重度不良事件。这些数据支持在 ARD 患者中使用 CoronaVac，表明短期免疫原性降低但可接受。该试验仍在进行中，以评估长期有效性/免疫原性。