Booster trial aims to improve immunity in vulnerable people

Young African American man receiving a COVID-19 vaccine

Credit: Ivan Pantic, Getty Images

A clinical trial is investigating if taking a break from immune-suppressing drugs can help vulnerable people mount a better immune response to COVID-19 booster jabs.

The vaccine response on/off methotrexate (VROOM) trial is led by the University of Nottingham and funded by:

  • Medical Research Council
  • National Institute for Health Research (NIHR).

1.3 million prescribed methotrexate

Around 1.3 million people in the UK are prescribed methotrexate, an immune-suppressing drug, for conditions like rheumatoid arthritis and psoriasis.

Methotrexate is effective at controlling these conditions and is as first-line therapy for many illnesses.

But it reduces the body’s ability to fight infections and generate a robust response to flu and pneumonia vaccines.

Many of the people who take methotrexate were among those advised to shield in the first phase of the pandemic.

Pausing medication after COVID-19 booster

The VROOM team is recruiting 560 patients currently taking methotrexate.

They will investigate whether taking a two-week break in this drug immediately after receiving the COVID-19 booster jab improves their immune response to vaccination.

They will also investigate whether this also prevents flare-ups of their long-term illness.

The study will take between one to two years to complete.

All participants will have had the Pfizer-BioNTech vaccine as their third jab as part of the national vaccination programme against COVID-19.

Two-week ‘treatment holiday’

A previous study from Korea showed that a two-week ‘treatment holiday’ from methotrexate after the flu vaccine increased the patients’ immune response to that vaccine.

But it isn’t known if such an interruption in treatment would improve the protection provided by vaccines against COVID-19.

Double-edged sword

Professor Abhishek, Professor of Rheumatology, at the University of Nottingham and Honorary Consultant Rheumatologist Nottingham University Hospitals NHS Trust, said:

People with inflammatory conditions such as rheumatoid arthritis and skin diseases such as psoriasis face a daily battle dealing with painful and troubling effects of their illness.

This can leave them unable to carry out daily tasks independently.

At the same time, they face a double-edged sword of being more vulnerable to COVID-19, while potentially unable to mount the strongest possible immune response to vaccines against COVID-19, to protect them from the virus following their jab, leaving many of them still fearing the virus.

We hope to find out whether they can safely take a break from medications for their inflammatory conditions and an improved protection from the booster jab, without the risk of a flare-up of their long-term illness which affects their daily lives so heavily.

Over 20 UK hospitals taking part

The study is being delivered in partnership with Oxford Clinical Trials Research Unit at the University of Oxford.

It is running in over 20 hospitals in the UK, supported by the NIHR’s Clinical Research Network.

Last updated: 2 February 2022

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