New trial explores improved vaccine responses in patients with IBD

Imperial researchers launch trial exploring improved vaccine responses in patients with inflammatory bowel disease.

"This study will help us understand whether carefully timed treatment pauses can make vaccination more effective - ultimately helping to better protect patients.” Dr James Alexander Co-Chief Investigator and Clinical Lead of the OVATION-IBD trial

A team of researchers at Imperial College London and Imperial College Healthcare NHS Trust have launched a new clinical trial, funded by GlaxoSmithKline (GSK), to investigate whether temporarily pausing treatment in patients with inflammatory bowel disease (IBD) can enhance immune responses to the Shingrix vaccine, which protects against shingles. The trial will recruit 268 participants from Imperial College Healthcare NHS Trust and partner hospitals.

People living with IBD are often prescribed Janus Kinase inhibitor (JAK-i) medication - immune-modifying therapies to control inflammation. While these medicines are highly effective in managing the disease, they may also reduce the body’s ability to mount a strong immune response to vaccines. Shingrix is a non-live recombinant vaccine shown to be highly effective in the general population, but its performance in immunosuppressed groups remains under investigation.

The Imperial-led study will explore whether a short-term pause in JAK-i therapy around the time of vaccination can safely boost immune responses without increasing the risk of IBD deterioration.

In the trial, 268 participants from Imperial College Healthcare NHS Trust and partner hospitals  will be randomised to either pausing or not pausing their JAK-I therapy, and receive the standard two-dose Shingrix vaccine while their immune responses and IBD activity are carefully monitored. Delivery of the trial will be managed by the Imperial Clinical Trials Unit.

Nick Powell, Professor of Gastroenterology at Imperial’s Department of Metabolism, Digestion and Reproduction, co-lead of the NIHR Imperial Biomedical Research Centre (BRC) Digestive Diseases Theme, and Chief Investigator of the OVATION-IBD trial said: “We’re delighted to be receiving over £2.5 million from GSK for this important clinical trial. Our patients are highly engaged in research, and this trial addresses a question that is directly relevant to their care - how best to balance IBD treatment safety with protection against infections like shingles.”

Dr James Alexander, consultant gastroenterologist at Imperial College Healthcare NHS Trust, Honorary Senior Lecturer at Imperial’s Department of Metabolism, Digestion and Reproduction, and Co-Chief Investigator and Clinical Lead of the OVATION-IBD trial, said: “People with inflammatory bowel disease on JAK-I therapy are at particularly high risk of shingles. We have previously shown that patients with IBD on JAK-I therapy have reduced responses to vaccination against COVID-19 and influenza. This study will help us understand whether carefully timed treatment pauses can make vaccination more effective - ultimately helping to better protect patients.”

Funded by GSK, the manufacturer of Shingrix, this research is part of efforts to optimise and personalise vaccination strategies for people living with chronic immune-mediated diseases.

Research at the Trust is supported by the NIHR Imperial Biomedical Research Centre (BRC), a translational research partnership between Imperial College Healthcare NHS Trust and Imperial College London, which was awarded £95m in 2022 to continue developing new experimental treatments and diagnostics for patients.