nderstanding the impact of treatments for inflammatory bowel disease on immune responses to SARS-CoV2 vaccinatio

Not Applicable

Completed

• Conditions: Immune responses to SARS-CoV-2 vaccination in immunosuppressed inflammatory bowel disease patients.; Not Applicable

• Registration Number: ISRCTN13495664
• Lead Sponsor: Imperial College London

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-13
• Study Completion: 2022-06-01
• Last Update Posted: 30 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 483

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

• Study Type: Observational
• Study Design: Not specified