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BNT162B2 mRNA新冠疫苗在采用不同免疫抑制方案的炎症性肠病儿科人群中的安全性和免疫原性评估。

Evaluation of Safety and Immunogenicity of BNT162B2 mRNA COVID-19 Vaccine in IBD Pediatric Population with Distinct Immune Suppressive Regimens.

作者信息

Cotugno Nicola, Franzese Enrica, Angelino Giulia, Amodio Donato, Romeo Erminia Francesca, Rea Francesca, Faraci Simona, Tambucci Renato, Profeti Elisa, Manno Emma Concetta, Santilli Veronica, Rotulo Gioacchino Andrea, Pighi Chiara, Medri Chiara, Morrocchi Elena, Colagrossi Luna, Pascucci Giuseppe Rubens, Valentini Diletta, Villani Alberto, Rossi Paolo, De Angelis Paola, Palma Paolo

机构信息

Research Unit of Clinical Immunology and Vaccinology, Academic Department of Pediatrics (DPUO), Bambino Gesù Children's Hospital, IRCCS, 00165 Rome, Italy.

Chair of Pediatrics, Department of Systems Medicine, University of Rome "Tor Vergata", 00185 Rome, Italy.

出版信息

Vaccines (Basel). 2022 Jul 11;10(7):1109. doi: 10.3390/vaccines10071109.

DOI:10.3390/vaccines10071109
PMID:35891273
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9318731/
Abstract

Patients affected by Inflammatory Bowel Disease (IBD) present higher risk for infection and suboptimal response upon vaccination. The immunogenicity of SARS-CoV2 vaccination is still largely unknown in adolescents or young adults affected by IBD (pIBD). We investigated the safety and immunogenicity of the BNT162B2 mRNA COVID-19 vaccine in 27 pIBD, as compared to 30 healthy controls (HC). Immunogenicity was measured by anti-SARS-CoV2 IgG (anti-S and anti-trim Ab) before vaccination, after 21 days (T21) and 7 days after the second dose (T28). The safety profile was investigated by close monitoring and self-reported adverse events. Vaccination was well tolerated, and short-term adverse events reported were only mild to moderate. Three out of twenty-seven patients showed IBD flare after vaccination, but no causal relationship could be established. Overall, pIBD showed a good humoral response upon vaccination compared to HC; however, pIBD on anti-TNFα treatment showed lower anti-S Ab titers compared to patients receiving other immune-suppressive regimens ( = 0.0413 at first dose and = 0.0301 at second dose). These data show that pIBD present a good safety and immunogenicity profile following SARS-CoV-2 mRNA vaccination. Additional studies on the impact of specific immune-suppressive regimens, such as anti TNFα, on immunogenicity should be further investigated on larger cohorts.

摘要

炎症性肠病(IBD)患者感染风险较高,接种疫苗后的反应也不理想。SARS-CoV2疫苗在受IBD影响的青少年或年轻人(pIBD)中的免疫原性仍 largely未知。我们调查了27名pIBD患者中BNT162B2 mRNA新冠疫苗的安全性和免疫原性,并与30名健康对照(HC)进行了比较。在接种前、21天(T21)和第二剂后7天(T28)通过抗SARS-CoV2 IgG(抗S和抗三聚体抗体)测量免疫原性。通过密切监测和自我报告的不良事件来调查安全性。疫苗接种耐受性良好,报告的短期不良事件仅为轻度至中度。27名患者中有3名在接种疫苗后出现IBD发作,但无法确定因果关系。总体而言,与HC相比,pIBD在接种疫苗后表现出良好的体液反应;然而,与接受其他免疫抑制方案的患者相比,接受抗TNFα治疗的pIBD患者的抗S抗体滴度较低(第一剂时P = 0.0413,第二剂时P = 0.0301)。这些数据表明,pIBD在接种SARS-CoV-2 mRNA疫苗后具有良好的安全性和免疫原性。关于特定免疫抑制方案(如抗TNFα)对免疫原性影响的进一步研究应在更大的队列中进行。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ee4f/9318731/fea5d26e0813/vaccines-10-01109-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ee4f/9318731/2d65a2c4923d/vaccines-10-01109-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ee4f/9318731/fea5d26e0813/vaccines-10-01109-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ee4f/9318731/2d65a2c4923d/vaccines-10-01109-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ee4f/9318731/fea5d26e0813/vaccines-10-01109-g002.jpg

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