SARS-CoV2 Vaccination immunogenicity
in Immunosuppressed inflammatory bowel disease Patients
ABOUT THE VIP STUDY
The VIP study is being run at Imperial College London, Royal Devon and Exeter Hospital, Western General, Edinburgh, Barts Health NHS Trust, Cambridge University Hospitals and London North West Healthcare NHS Trust.
The ultimate purpose of this study is to determine whether patients on different immunosuppressive drugs have impaired immune responses to SARS-CoV-2 vaccination. We will also investigate important mechanisms of successful vaccination and identify predictors of vaccination failure. This information will help planning for treatment and vaccination of immunosuppressed patients in the future.
WHY AND HOW?
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 IBD patients undergoing vaccination against SARS-CoV-2 at 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), and 200 healthy participants will be recruited. We will measure antibody levels and how the immune system responds to the vaccine over time. We will follow participants over two study visits, between 53- 92 days after the second dose of vaccine and 28-49 days after the 3rd primary/booster dose.