在一项随机对照试验中,在接受免疫抑制剂治疗的系统性自身免疫性疾病患者中进行潜在的SARS-CoV-2增强疫苗接种
medRxiv : the preprint server for health sciences
|April 8, 2025
概括
提振剂COVID-19疫苗有效地增加了自身免疫患者的抗体水平,这些患者接受了免疫抑制剂,如mycophenolate mofetil/mycophenolic acid (MMF/MPA) 和methotrexate (MTX),即使继续服用药物. 额外的疫苗接种是安全的,并且耐受良好.
科学领域:
- 免疫学 免疫学 免疫学
- 疫苗学 疫苗学 疫苗学
- 自免疫性疾病 自免疫性疾病
背景情况:
- 接受免疫抑制剂的自身免疫疾病患者往往对初始COVID-19疫苗的免疫反应减弱.
- 增剂疫苗剂量的有效性以及在接种疫苗期间暂停免疫抑制药物的影响尚不清楚.
研究的目的:
- 为了评估额外的COVID-19疫苗剂量的疗效和安全性,在自身免疫性疾病患者中接受了用mycophenolate mofetil/mycophenolic acid (MMF/MPA),methotrexate (MTX) 或B细胞消耗疗法 (BCDT) 的治疗.
- 调查 MMF / MPA 或 MTX 在补丁疫苗接种期间保留对免疫反应和安全的影响.
主要方法:
- 一个开放的,多中心的,随机的试验,涉及151名自身免疫疾病患者,其初级COVID-19疫苗反应不足最佳.
- 参与者接受了一种同源的强化疫苗. 随机分配MMF/MPA和MTX组,在接种疫苗时继续或停止服用药物.
- 主要终点是抗受体结合域 (RBD) 抗体度在增强剂后4周的变化. 二级终点包括不良事件,COVID-19感染和疾病活动.
主要成果:
- 额外的疫苗接种在MMF/MPA和MTX组中显著增加了抗RBD抗体度,无论免疫抑制是否继续或停止.
- 接受BCDT治疗的患者也显示抗RBD水平增加,尽管通常低于MMF/MPA和MTX组.
- COVID-19感染大多是轻微的,并且强剂疫苗接种被很好地容忍,很少出现严重的不良事件或疾病爆发.
结论:
- 对于接受MMF/MPA,MTX或BCDT的自身免疫患者来说,额外的COVID-19疫苗剂量是有效和安全的.
- 在补充疫苗接种期间保留MMF/MPA或MTX不会影响免疫反应,并且与良好的安全结果有关.
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