RecruitingPhase IVInterventional

Optimizing herpes zoster vaccination in immunosuppressed patients with inflammatory bowel disease

This study investigates how to improve the shingles vaccine's effectiveness in people with Inflammatory Bowel Disease (IBD), such as Crohn's and Ulcerative Colitis. These individuals often take medications called JAK-inhibitors, which can make them more prone to infections like shingles. The study aims to see if briefly stopping these medications around the time of vaccination helps the vaccine work better. Participants will be split into two groups: one continues their medication as usual, and the other pauses it for seven days during vaccination. Researchers will compare results to find the best approach, potentially improving health outcomes for those with IBD and other conditions treated with similar drugs.

At a glance

Status

Recruiting

Phase

Phase IV

Sponsor

Imperial College London

Enrolment target

268

Start

01 Mar 2026

Estimated completion

02 Jul 2027

Inflammatory bowel disease

What is this study about?

Inflammatory Bowel Disease (IBD) is a long-term condition where the body's immune system mistakenly attacks the gut, leading to symptoms like stomach pain, bleeding, and diarrhoea. Many people with IBD take medications called JAK-inhibitors to help manage their symptoms. While these medicines are very helpful, they work by lowering the immune system's activity, which can unfortunately make people more vulnerable to infections.

One particular infection that people taking JAK-inhibitors are at a higher risk of catching is shingles. Shingles is a painful rash, similar to chickenpox, and can affect adults who have had chickenpox in the past. There's a vaccine available that can help protect against shingles. However, some medications, including JAK-inhibitors, might make vaccines less effective because they reduce the immune system's response.

This study aims to find out if temporarily stopping JAK-inhibitor medication for a short period can help the shingles vaccine work better for people with IBD. By understanding this, the researchers hope to optimize vaccination strategies, potentially leading to better protection against shingles for people with IBD and those with other illnesses, like arthritis, who also take these types of medications.

Key takeaways

This study explores how to improve shingles vaccine effectiveness for people with IBD.
It focuses on patients taking JAK-inhibitor medications.
The main question is if pausing medication helps the vaccine work better.
Participation involves either continuing medication or briefly pausing it during vaccination.
The study takes place over 14 months with hospital visits and phone calls.
Findings could improve shingles protection for many patients onJAK-inhibitors.

Who may be eligible?

This study is looking for adults aged 18 or over who have Inflammatory Bowel Disease (IBD), including Crohn's disease or Ulcerative Colitis. You must have had chickenpox at some point in your life, as this means you're at risk of shingles.

To join, you need to be taking a specific type of medication called a JAK-inhibitor for at least 12 weeks, and your IBD must be stable and well-controlled. Your medical team needs to agree that it would be safe for you to temporarily pause your JAK-inhibitor medication for two short periods without making your IBD worse.

You cannot participate if you've already had a shingles vaccine before, or if you've had a severe allergic reaction to any vaccine in the past. Also, if you've had shingles or ongoing nerve pain from shingles in the last year, or if your JAK-inhibitor is mainly for a different condition like rheumatoid arthritis, you won't be able to join this particular study.

Quick self-check

Are you an adult aged 18 or over?
Do you have IBD (Crohn's or Ulcerative Colitis)?
Have you had chickenpox before?
Are you currently taking a JAK-inhibitor medication for your IBD and is your IBD stable?
Has your doctor confirmed it would be safe for you to briefly pause your medication if needed?
Have you never had a shingles vaccine before?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you'll be assigned to one of two groups, much like flipping a coin. One group will continue taking their JAK-inhibitor medication as usual and receive two doses of the shingles vaccine. The other group will pause their IBD medication for seven days at a time when they receive two doses of the shingles vaccine. Researchers will then compare the results from both groups.

This study will involve attending around five hospital visits over 14 months at one of about five UK hospitals. In between visits, there will be follow-up phone calls. The total duration of your involvement in the study will be approximately 14 months.

Potential risks and benefits

It's not certain if there will be direct benefits to you from joining this study. The main aim is to see if pausing JAK-inhibitor medication helps the shingles vaccine work better. If successful, this research could improve future care for people with IBD and other conditions treated with similar medications by finding the best way to get protected against shingles. As for risks, the Shingrix vaccine can cause side effects like arm soreness, swelling, aches, or flu-like feelings, which usually clear up within three days. In very rare cases (1 in 1,000 doses), serious allergic reactions can occur. You are free to withdraw from the study at any time without affecting your usual medical care.

Locations (2)

Imperial College Healthcare NHS Trust
London, England
Hull University Teaching Hospitals NHS Trust
Hull, England

Common questions

What is Inflammatory Bowel Disease (IBD)?

IBD is a condition where your body's immune system attacks your gut, causing symptoms like stomach pain, bleeding, and diarrhoea. It includes conditions like Crohn's disease and Ulcerative Colitis.

What are JAK-inhibitors?

These are medications often used for IBD that work by reducing the activity of your immune system. While helpful, they can increase your risk of infections like shingles.

What is shingles?

Shingles is a painful skin rash caused by the same virus as chickenpox. If you've had chickenpox, you can get shingles later in life.

Will I have to stop my IBD medication if I join?

Only if you are in the group that pauses medication. That group will stop their JAK-inhibitor for two separate 7-day periods around their vaccine doses. Your medical team will first confirm if this is safe for you.

What if I get pregnant during the study?

If you are pregnant or planning to become so, you cannot join. If you become pregnant during the study, you will not receive further vaccine doses, but your safety will still be monitored.

How to find out more

Maria Moreno Morales

m.moreno-morales@imperial.ac.uk - Official trial record

Always speak to your GP or specialist before deciding to take part in a study.