新冠病毒mRNA疫苗在儿童风湿性疾病患者中的体液和细胞免疫原性、有效性及安全性：一项前瞻性队列研究

Humoral and cellular immunogenicity, effectiveness and safety of COVID-19 mRNA vaccination in patients with pediatric rheumatic diseases: A prospective cohort study.

作者信息

Hamad Saied Mohamad, van Straalen Joeri W, de Roock Sytze, Verduyn Lunel Frans M, de Wit Jelle, de Rond Lia G H, Van Nieuwenhove Erika, Vastert Bas J, van Montfrans Joris M, van Royen-Kerkhof Annet, de Joode-Smink Gerrie C J, Swart Joost F, Wulffraat Nico M, Jansen Marc H A

机构信息

Department of Pediatric Immunology and Rheumatology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, the Netherlands; Department of Pediatrics, Carmel Medical Center, Technion Faculty of Medicine, Haifa, Israel.

Department of Pediatric Immunology and Rheumatology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, the Netherlands.

出版信息

Vaccine. 2024 Feb 15;42(5):1145-1153. doi: 10.1016/j.vaccine.2024.01.047. Epub 2024 Jan 22.

DOI:10.1016/j.vaccine.2024.01.047

PMID:38262809

Abstract

OBJECTIVES

To evaluate immunogenicity, effectiveness and safety of COVID-19 vaccination in patients with pediatric autoimmune inflammatory rheumatic disease (pedAIIRD).

METHODS

A prospective cohort study was performed at the pediatric rheumatology department of the Wilhelmina Children's Hospital in Utrecht, the Netherlands. Vaccination dates, COVID-19 cases and vaccine-related adverse events (AEs) were registered for all pedAIIRD patients during regular clinic visits from March 2021 - August 2022. SARS-CoV-2 IgG antibody levels and T-cell responses were measured from serum samples after vaccination, and clinical and drug therapy data were collected from electronic medical records. Rate of COVID-19 disease was compared between vaccinated and unvaccinated patients in a time-varying Cox regression analysis.

RESULTS

A total of 157 patients were included in this study and 88 % had juvenile idiopathic arthritis (JIA). One hundred thirty-seven patients were fully vaccinated, of which 47 % used biological agents at the time of vaccination, and 20 patients were unvaccinated. Geometric mean concentrations (GMCs) of post-vaccine antibody levels against SARS-CoV-2 were above the threshold for positivity in patients who did and did not use biological agents at the time of vaccination, although biological users demonstrated significantly lower antibody levels (adjusted GMC ratio: 0.38, 95 % CI: 0.21 - 0.70). T-cell responses were adequate in all but two patients (9 %). The adjusted rate of reported COVID-19 was significantly lower for fully vaccinated patients compared to non-vaccinated patients (HR: 0.53, 95 % CI: 0.29 - 0.97). JIA disease activity scores were not significantly different after vaccination, and no serious AEs were reported.

CONCLUSIONS

COVID-19 mRNA vaccines were immunogenic (both cellular and humoral), effective and safe in a large cohort of pedAIIRD patients despite their use of immunosuppressive medication.

摘要

目的

评估新冠病毒疫苗在儿童自身免疫性炎性风湿性疾病（pedAIIRD）患者中的免疫原性、有效性和安全性。

方法

在荷兰乌得勒支的威廉明娜儿童医院儿科风湿病科进行了一项前瞻性队列研究。在2021年3月至2022年8月的定期门诊就诊期间，记录了所有pedAIIRD患者的疫苗接种日期、新冠病毒病例和疫苗相关不良事件（AE）。接种疫苗后，从血清样本中测量严重急性呼吸综合征冠状病毒2（SARS-CoV-2）IgG抗体水平和T细胞反应，并从电子病历中收集临床和药物治疗数据。在时变Cox回归分析中，比较了接种疫苗和未接种疫苗患者的新冠病毒疾病发生率。

结果

本研究共纳入157例患者，88%患有幼年特发性关节炎（JIA）。137例患者完成全程接种，其中47%在接种疫苗时使用生物制剂，20例患者未接种疫苗。接种疫苗时使用和未使用生物制剂的患者中，针对SARS-CoV-2的疫苗接种后抗体水平几何平均浓度（GMC）均高于阳性阈值，尽管使用生物制剂的患者抗体水平显著较低（调整后的GMC比值：0.38，95%置信区间：0.21 - 0.70）。除两名患者（9%）外，所有患者的T细胞反应均充足。与未接种疫苗的患者相比，完成全程接种的患者报告的新冠病毒调整发生率显著较低（风险比：0.53，95%置信区间：0.29 - 0.97）。接种疫苗后，JIA疾病活动评分无显著差异，未报告严重AE。