Impact of biologic therapy on SARS-CoV-2 infection and immunity in patients with inflammatory bowel disease
- Conditions
- COVID-19 (SARS-CoV-2 infection), inflammatory bowel diseaseInfections and Infestations
- Registration Number
- ISRCTN45176516
- Lead Sponsor
- Royal Devon & Exeter NHS Foundation Trust
- Brief Summary
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33903149/ SARS-CoV-2 vaccine immunogenicity results (added 13/08/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33753421/ anti-SARS-CoV-2 antibody response result (added 13/08/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35902214/ Vaccine escape, increased breakthrough and reinfection in infliximab-treated patients with IBD during the Omicron wave of the SARS-CoV-2 pandemic (added 29/07/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36481043/ Neutralising antibody potency against SARS-CoV-2 wt and omicron BA.1 and BA.4/5 variants in patients with IBD treated with infliximab and vedolizumab (added 12/12/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35296643/ Antibody decay, T cell immunity and breakthrough infections (added 23/01/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 6935
1. Age 5 years and over
2. Diagnosis of inflammatory bowel disease
3. Current treatment with infliximab or vedolizumab for 6 weeks or more
4. Written informed consent obtained from patient or parent/guardian
Patients participating in a vaccine trial
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Workflow 1– retrospective study:<br> Cumulative seropositivity of anti-SARS-CoV-2 antibodies, measured using the Roche Elecsys assay between 01/01/2020 and 30/09/2020<br><br> Workflow 2:<br> Positive anti-SARS-CoV-2 antibody test, using the Roche Elecsys assay, at week 0 or week 40<br>
- Secondary Outcome Measures
Name Time Method