Understanding the impact of treatments for inflammatory bowel disease on immune responses to SARS-CoV2 vaccination

SARS-CoV2 Vaccination immunogenicity in Immunosuppressed inflammatory bowel disease Patients

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN13495664

Enrollment

600

Registered

2021-12-13

Start date

2021-05-28

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

600 IBD patients will be recruited stratified according to the immunosuppressive medication they are on. Patients must have been for at least 3 months on the following treatments: thiopurines (n=100),

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Immunogenicity to routinely administered SARS-CoV2 vaccination at day 60-85 post second dose of vaccination, measured as the geometric mean titre of Anti-SARS-CoV-2 spike (S) antibodies (Roche Elecsys immunoassay)in IBD patients on immunosuppressive treatment regimens compared to non-IBD control participants.	—

Secondary

Measure	Time frame
1. Immunogenicity to vaccination at the first visit (between days 60- 85) post second dose of vaccination, measured as the geometric mean titres of S1 binding IgG and RBD IgG antibodies in IBD patients on immunosuppressive treatment regimens compared to non-IBD control participants. 2. Immunogenicity to a third dose (or booster dose) of vaccination at the second visit, 35-42 days (+/- 7 days) following the third dose, measured as the geometric mean titres of neutralising anti-SARS-CoV2 antibodies, S1-binding IgG antibodies and RBD IgG antibodies in IBD patients. 3. Proportion of IBD patients on immunosuppressive treatment regimens compared to non-IBD control participants with seroprotection against SARS-CoV2 at the first visit (between days 60- 85) and at the second visit (35-42 days following third dose of vaccine). 4. Adaptive immune response to vaccination measured using T cell assays and longitudinal transcriptomics in each study arm.	—

Measure

Time frame

1. Immunogenicity to vaccination at the first visit (between days 60- 85) post second dose of vaccination, measured as the geometric mean titres of S1 binding IgG and RBD IgG antibodies in IBD patients on immunosuppressive treatment regimens compared to non-IBD control participants. 2. Immunogenicity to a third dose (or booster dose) of vaccination at the second visit, 35-42 days (+/- 7 days) following the third dose, measured as the geometric mean titres of neutralising anti-SARS-CoV2 antibodies, S1-binding IgG antibodies and RBD IgG antibodies in IBD patients. 3. Proportion of IBD patients on immunosuppressive treatment regimens compared to non-IBD control participants with seroprotection against SARS-CoV2 at the first visit (between days 60- 85) and at the second visit (35-42 days following third dose of vaccine). 4. Adaptive immune response to vaccination measured using T cell assays and longitudinal transcriptomics in each study arm.

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Countries

England, Scotland, United Kingdom

Contacts

Public ContactJames Alexander

j.alexander@imperial.ac.uk+44 (0)20 7589 5111

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 19, 2026