VIP [COVID-19]
Research type
Research Study
Full title
Vaccination Immunogenicity against SARS-CoV2 in Patients with inflammatory bowel disease
IRAS ID
292123
Contact name
Nicholas Powell
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Vaccination is likely to be a key weapon to protect the health of the world’s population from COVID19 and is likely to be especially important in high risk individuals, such as those with pre-existing conditions including Inflammatory bowel disease (IBD).
Many IBD patients take immunosuppressive drugs, which leaves them vulnerable to infection. However, the risks associated with immunosuppression are not limited to increased susceptibility to infection. Immunosuppressive drugs may reduce the effectiveness of some vaccines, which could have major implications for the safety of immunosuppressed patients in the COVID-19 era.
VIP is a prospective observational study to be conducted in multiple centres across the United Kingdom. 600 IBD patients on different IBD medication (immunomodulators, anti-TNFs, combination immunomodulator and anti-TNF, Vedolizumab, Ustekinumab and Tofacitinib) will be recruited. Participants will be recruited after receiving SARS-CoV2 vaccination. We will collect demographic and clinical data, as well as blood samples. We will measure antibody levels and how the immune system has responded to vaccination at 60 days and week 26 after the second dose of vaccine has been given.
The purpose of this study is to determine whether patients on different immunosuppressive drugs have impaired immune responses to SARS-CoV2 vaccination.
REC name
Wales REC 5
REC reference
21/WA/0105
Date of REC Opinion
19 Mar 2021
REC opinion
Favourable Opinion