Trial Details

Not Recruiting
Basic Information
Clinical ID c2333
Identifier ISRCTN13495664
Trial Title SARS-CoV2 Vaccination immunogenicity in Immunosuppressed inflammatory bowel disease Patients
Trial URL Visit Original Page
Study Information
Study Results

Yes

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), infliximab (anti-TNF) (n=100), combination infliximab/thiopurines (n=100), vedolizumab (n=100), ustekinumab (n=100) and tofacitinib (n=100). 200 healthy people without IBD will also be recruited. Following pre-screening, participants will be consented and enrolled in the study. Details including IBD phenotype, patient demographics and disease activity will be collected via the patient questionnaires, which will be completed after study consent is given. 40mL blood draw will be sampled at 2 time points, after 2nd dose of vaccination (days 60- 85), and 35-42 days post third dose of vaccine, to assess serology and T-cell responses.
Participant Information
Sponsor Imperial College London
City -
Country/Region United Kingdom
Enrollment Criteria
Sex Requirement ALL
Age Requirement -
Study Design
Study Type Observational
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date 2022-06-01