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儿童期起病的风湿性疾病患者青少年和年轻成人对 SARS-CoV-2 mRNA 疫苗接种的强大中和抗体反应。

Robust neutralizing antibody response to SARS-CoV-2 mRNA vaccination in adolescents and young adults with childhood-onset rheumatic diseases.

机构信息

Translational Immunology Institute, SingHealth Duke-NUS Academic Medical Centre.

Rheumatology and Immunology Service, Department of Paediatric Subspecialities, KK Women's and Children's Hospital.

出版信息

Rheumatology (Oxford). 2022 Nov 2;61(11):4472-4481. doi: 10.1093/rheumatology/keac105.

Abstract

OBJECTIVES

Immunogenicity to the SARS-CoV-2 mRNA vaccines in adolescents and young adults (AYA) with childhood-onset rheumatic diseases (cRD) is unknown. We aimed to evaluate the humoral immunogenicity and safety of the vaccines in our AYA with cRD.

METHODS

A monocentric observational study with 159 AYA (50.3% female and 70.4% Chinese). Humoral immunogenicity was assessed at 2-3 and 4-6 weeks following first and second vaccination by cPass™ SARS-CoV-2 Neutralization Antibody Assay. Inhibition signal of ≥30% defined the cut-off for positive detection of the SARS-CoV-2 neutralizing antibodies. Vaccine safety and disease activity were assessed within 6 weeks after second vaccination.

RESULTS

A total of 64.9% and 99.1% of 159 patients (median age: 16.9, IQR: 14.7-19.5) mounted positive SARS-CoV-2 neutralizing responses after first and second vaccination, respectively. Most patients (89.8%) had ≥90% inhibition signal after second vaccination. Methotrexate and mycophenolate mofetil increased the risk associated with negative cPass neutralization responses following the first vaccination. Holding both medications after each vaccination did not affect immunogenicity. There was no symptomatic COVID-19 infection. Local reaction remained the most common (23.3-25.2%) adverse event, without serious complication. Two and seven patients flared following the first and second vaccination, respectively. Subgroup analyses of the 12-18-year-old cohort did not show any differences in vaccine efficacy, predictors of poor response and general safety, but higher proportion of disease flares.

CONCLUSIONS

SARS-CoV-2 mRNA vaccines were efficacious after the two-dose regimen in almost all AYA with cRD without serious adverse event. The rate of disease flare observed is 4.4% after the second mRNA vaccine dose.

摘要

目的

患有儿童期发病的风湿性疾病(cRD)的青少年和年轻成人(AYA)对 SARS-CoV-2 mRNA 疫苗的免疫原性尚不清楚。我们旨在评估我们的 cRD AYA 中疫苗的体液免疫原性和安全性。

方法

一项单中心观察性研究,纳入了 159 名 AYA(50.3%为女性,70.4%为中国人)。通过 cPass™SARS-CoV-2 中和抗体测定法在首次和第二次接种后 2-3 周和 4-6 周评估体液免疫原性。抑制信号≥30%定义为 SARS-CoV-2 中和抗体阳性检测的截止值。在第二次接种后 6 周内评估疫苗安全性和疾病活动度。

结果

159 例患者(中位数年龄:16.9,IQR:14.7-19.5)中,分别有 64.9%和 99.1%在首次和第二次接种后产生了阳性 SARS-CoV-2 中和反应。大多数患者(89.8%)在第二次接种后具有≥90%的抑制信号。甲氨蝶呤和霉酚酸酯增加了首次接种后阴性 cPass 中和反应的风险。每次接种后保留这两种药物并不影响免疫原性。没有出现有症状的 COVID-19 感染。局部反应仍然是最常见的(23.3%-25.2%)不良事件,没有严重并发症。在首次和第二次接种后,分别有 2 例和 7 例患者出现病情加重。12-18 岁年龄组的亚组分析并未显示疫苗疗效、不良反应预测因子和总体安全性方面存在差异,但疾病加重的比例更高。

结论

在所有 cRD AYA 中,两剂 SARS-CoV-2 mRNA 疫苗均有效,且无严重不良事件。第二次 mRNA 疫苗接种后,观察到的疾病加重率为 4.4%。

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