Alzahra Research Institute, Alzahra University Hospital, Isfahan University of Medical Sciences, Isfahan, Iran.
Network of Immunity in Infection, Malignancy, and Autoimmunity (NIIMA), Universal Scientific Education and Research Network (USERN), Isfahan, Iran.
Front Immunol. 2023 Feb 21;14:952911. doi: 10.3389/fimmu.2023.952911. eCollection 2023.
People with multiple sclerosis (pwMS) on anti-CD20 therapies (aCD20) and fingolimod have shown inadequate humoral responses to COVID-19 vaccines.
The objective of the study was to pilot larger studies by demonstrating the safety and comparing the immunogenicity of different types of third doses in seronegative pwMS after two doses of BBIBP-CorV inactivated vaccine.
In December 2021, subject to receiving their third dose, being COVID-19-naiive, and receiving no corticosteroid within two months, we measured the level of anti-SARS-CoV-2-Spike IgG in pwMS seronegative after two shots of BBIBP-CorV inactivated vaccine.
We included 20/29 pwMS who received adenoviral vector (AV), 7/29 who received inactivated, and 2/29 who received conjugated third doses. No serious adverse events were reported two weeks post-third dose. The pwMS receiving AV third doses showed significantly increased IgG concentrations, while only the ones on aCD20 and fingolimod responded to inactivated third doses. An ordinal logistic multivariable generalized linear model indicated that age (per year β: -0.10, P = 0.04), type of disease-modifying therapy (aCD20 β: -8.36, P <0.01; fingolimod β: -8.63, P = 0.01; others: reference), and type of third dose (AV or conjugated β: 2.36, P = 0.02; inactivated: reference) are predictive of third dose immunogenicity among pwMS who remain seronegative after two shots of BBIBP-CorV vaccine. Statistical significance was not achieved for variables sex, MS duration, EDSS, duration of DMT, duration of third dose to IgG test, and duration from last aCD20 infusion to third dose.
This preliminary pilot study highlights the need for further research to determine the optimal COVID-19 third dose vaccination strategy for pwMS living in areas where BBIBP-CorV vaccine has been used.
接受抗 CD20 治疗（aCD20）和芬戈利莫德治疗的多发性硬化症（pwMS）患者对 COVID-19 疫苗的体液反应不足。
本研究的目的是通过证明安全性并比较不同类型的第三剂在接受两剂 BBIBP-CorV 灭活疫苗后血清阴性 pwMS 中的免疫原性，为更大规模的研究提供试点。
2021 年 12 月，在接受第三剂疫苗、对 COVID-19 呈阴性且在两个月内未接受皮质类固醇治疗的情况下，我们测量了两剂 BBIBP-CorV 灭活疫苗后血清阴性的 pwMS 中的抗 SARS-CoV-2-Spike IgG 水平。
我们纳入了 20/29 名接受腺病毒载体（AV）、7/29 名接受灭活、2/29 名接受结合第三剂的 pwMS。第三剂接种后两周内未报告严重不良事件。接受 AV 第三剂的 pwMS 显示 IgG 浓度显著增加，而仅接受 aCD20 和芬戈利莫德治疗的 pwMS 对灭活第三剂有反应。有序逻辑多元广义线性模型表明，年龄（每年 β：-0.10，P=0.04）、疾病修正治疗类型（aCD20 β：-8.36，P<0.01；芬戈利莫德 β：-8.63，P=0.01；其他：参考）和第三剂类型（AV 或结合 β：2.36，P=0.02；灭活：参考）是 BBIBP-CorV 疫苗两剂后仍呈血清阴性的 pwMS 第三剂免疫原性的预测因素。对于性别、MS 持续时间、EDSS、DMT 持续时间、第三剂到 IgG 检测的持续时间和最后一次 aCD20 输注到第三剂的持续时间等变量，未达到统计学意义。
这项初步试点研究强调需要进一步研究，以确定在 BBIBP-CorV 疫苗使用地区接受 COVID-19 第三剂疫苗接种的 pwMS 的最佳策略。
