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
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.
Summary of Results:
Why was this study needed?People with inflammatory bowel disease, also called IBD, often take medicines that reduce the activity of the immune system. IBD includes Crohn's disease and ulcerative colitis.
During the COVID-19 pandemic, it was important to understand whether these medicines affected how well people responded to COVID-19 vaccines. This was especially important because some immune-suppressing medicines can reduce the body's response to vaccines.
The VIP study looked at immune responses after COVID-19 vaccination in people with IBD who were taking different types of immune-suppressing treatment.
What did the study look at?
The study looked at how well people's immune systems responded to COVID-19 vaccines.
The researchers measured two parts of the immune response:
Antibodies
These are proteins made by the immune system. They help recognise and fight infections such as COVID-19.
T cells
These are immune cells that help the body respond to infections and support longer-term protection.The study included people who had received COVID-19 vaccines such as Pfizer, Moderna, or Oxford-AstraZeneca.
Who took part?
Nearly 600 people with IBD took part in the study. Some participants were recruited through the NIHR BioResource.
Participants gave blood samples and completed questionnaires at two study visits between May 2021 and March 2022.
Where did the study take place?
The study was carried out across several UK research centres:
Imperial College London
London North West University Healthcare NHS Trust Barts Health NHS Trust Cambridge NHS Lothian in Edinburgh Royal Devon and Exeter HospitalThree further London sites also helped recruit participants:
Guy's and St Thomas'
King's College Hospital
St George'sBlood samples were tested for antibody responses at the Royal Devon and Exeter Hospital. T cell responses were tested at Imperial College London.
What did the study find?
The study found reassuring results overall.
A third dose of a COVID-19 vaccine increased antibody levels in all IBD treatment groups. This means that booster vaccination helped improve the immune response, even in people taking immune-suppressing medicines.
However, some groups had lower immune responses than others. Antibody responses were lower in people taking:
infliximab
infliximab together with a thiopurine medicine tofacitinibTofacitinib was also linked with lower T cell responses.
Infliximab is an anti-TNF medicine. Tofacitinib is a Janus kinase inhibitor, also called a JAK inhibitor. Both are used to treat IBD by reducing inflammation, but they can also affect parts of the immune system.
What do the findings mean?
The findings support giving booster COVID-19 vaccine doses to people with IBD who are taking immune-suppressing medicines.
They suggest that booster doses are particularly important for people taking anti-TNF medicines, such as infliximab, and JAK inhibitors, such as tofacitinib.
The results should reassure people with IBD that COVID-19 booster vaccination can improve immune responses. At the same time, the results show that some treatment groups may remain more vulnerable and may benefit from continued prioritisation for future booster programmes.
Thank you
The VIP study team thanks everyone who took part. By giving blood samples and completing questionnaires, participants helped improve understanding of COVID-19 vaccine responses in people with IBD.
REC name
Wales REC 5
REC reference
21/WA/0105
Date of REC Opinion
19 Mar 2021
REC opinion
Favourable Opinion