PMID- 38262809 OWN - NLM STAT- MEDLINE DCOM- 20240226 LR - 20240229 IS - 1873-2518 (Electronic) IS - 0264-410X (Linking) VI - 42 IP - 5 DP - 2024 Feb 15 TI - Humoral and cellular immunogenicity, effectiveness and safety of COVID-19 mRNA vaccination in patients with pediatric rheumatic diseases: A prospective cohort study. PG - 1145-1153 LID - S0264-410X(24)00059-8 [pii] LID - 10.1016/j.vaccine.2024.01.047 [doi] AB - 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. CI - Copyright (c) 2024 The Authors. Published by Elsevier Ltd.. All rights reserved. FAU - Hamad Saied, Mohamad AU - Hamad Saied M AD - 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. Electronic address: Mohamad.hmd@gmail.com. FAU - van Straalen, Joeri W AU - van Straalen JW AD - Department of Pediatric Immunology and Rheumatology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, the Netherlands. FAU - de Roock, Sytze AU - de Roock S AD - Department of Pediatric Immunology and Rheumatology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, the Netherlands. FAU - Verduyn Lunel, Frans M AU - Verduyn Lunel FM AD - Department of Medical Microbiology, University Medical Center Utrecht, Utrecht, the Netherlands. FAU - de Wit, Jelle AU - de Wit J AD - Center for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands. FAU - de Rond, Lia G H AU - de Rond LGH AD - Center for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands. FAU - Van Nieuwenhove, Erika AU - Van Nieuwenhove E AD - Department of Pediatric Immunology and Rheumatology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, the Netherlands. FAU - Vastert, Bas J AU - Vastert BJ AD - Department of Pediatric Immunology and Rheumatology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, the Netherlands; Center for Translational Immunology, University Medical Center Utrecht, Utrecht, the Netherlands. FAU - van Montfrans, Joris M AU - van Montfrans JM AD - Department of Pediatric Immunology and Rheumatology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, the Netherlands. FAU - van Royen-Kerkhof, Annet AU - van Royen-Kerkhof A AD - Department of Pediatric Immunology and Rheumatology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, the Netherlands. FAU - de Joode-Smink, Gerrie C J AU - de Joode-Smink GCJ AD - Department of Pediatric Immunology and Rheumatology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, the Netherlands. FAU - Swart, Joost F AU - Swart JF AD - Department of Pediatric Immunology and Rheumatology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, the Netherlands. FAU - Wulffraat, Nico M AU - Wulffraat NM AD - Department of Pediatric Immunology and Rheumatology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, the Netherlands. FAU - Jansen, Marc H A AU - Jansen MHA AD - Department of Pediatric Immunology and Rheumatology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, the Netherlands. LA - eng PT - Journal Article DEP - 20240122 PL - Netherlands TA - Vaccine JT - Vaccine JID - 8406899 RN - 0 (Antibodies, Viral) RN - 0 (COVID-19 Vaccines) RN - 0 (RNA, Messenger) SB - IM MH - Child MH - Humans MH - Antibodies, Viral MH - *Arthritis, Juvenile/complications MH - *COVID-19/prevention & control MH - *COVID-19 Vaccines/administration & dosage MH - Immunogenicity, Vaccine MH - Prospective Studies MH - Rheumatic Diseases MH - RNA, Messenger MH - SARS-CoV-2 MH - Vaccination OTO - NOTNLM OT - COVID-19 mRNA vaccines OT - Cellular immunogenicity OT - Cohort study OT - Epidemiology OT - Humoral immunogenicity OT - Juvenile idiopathic arthritis OT - Pediatric rheumatic diseases OT - Vaccine effectivity OT - Vaccine safety COIS- Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. EDAT- 2024/01/24 00:43 MHDA- 2024/02/26 06:43 CRDT- 2024/01/23 21:54 PHST- 2023/08/14 00:00 [received] PHST- 2024/01/02 00:00 [revised] PHST- 2024/01/16 00:00 [accepted] PHST- 2024/02/26 06:43 [medline] PHST- 2024/01/24 00:43 [pubmed] PHST- 2024/01/23 21:54 [entrez] AID - S0264-410X(24)00059-8 [pii] AID - 10.1016/j.vaccine.2024.01.047 [doi] PST - ppublish SO - Vaccine. 2024 Feb 15;42(5):1145-1153. doi: 10.1016/j.vaccine.2024.01.047. Epub 2024 Jan 22.