SARS-CoV2 Vaccination immunogenicity in Immunosuppressed inflammatory bowel disease Patients

Imperial College London0 个研究点目标入组 483 人开始时间: 2021年12月13日最近更新: 2023年10月30日

试验速览

2022 Interim results article in https://pubmed.ncbi.nlm.nih.gov/35123676/ (added 07/02/2022) 2022 Results article in https://doi.org/10.1016/S2468-1253(22)00005-X (added 18/07/2023) 2022 Results article in https://doi.org/10.1016/S2468-1253(22)00274-6 (added 18/07/2023) 2023 Results article in https://doi.org/10.1053/j.gastro.2022.10.010 (added 18/07/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37842172/ (added 16/10/2023)

•1. Adults (aged =18 years)
•2. Established diagnosis of CD or UC using standard definitions of IBD or healthy people without IBD.
•3. Established on current immunosuppressive regimen (as listed in ‘study subjects’ section) for at least 12 weeks. This criteria does not apply to healthy participants without IBD.
•4. Receiving vaccination against SARS-CoV2
•5. Able to give informed consent.

•1. Unable to give informed consent
•2. Patients <18 years of age
•3. Recipients of ‘accelerated dosing’ of vaccination (I.e. second dose of SARS-CoV-2 vaccination given within 42 days of first dose).
•4. Patients on any other immune suppressants to those listed in study subjects section (other than oral steroids).
•5. Excluded medication includes:
•5.1. adalimumab
•5.2. golimumab
•5.3. certolizumab
•5.4. mesazaline
•5.5. mycophenolate
•5.6. tacrolimus
•5.7. thalidomide
•5.8. ciclosporin
•5.9. cyclophosphamide
•5.10. hydroxychloroquine
•5.11. leflunomide
•5.12. methotrexate
•5.13. mycophenolate
•5.14. sulfasalazine

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