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The Oxford Clinical Trials Research Unit (OCTRU) at NDORMS played a key role in the VROOM study which found that pausing immune-suppressing medicines such as methotrexate can increase the response to COVID-19 booster jabs.

Vials of the Covid-19 vaccine © SHUTTERSTOCK

A major clinical trial, led by experts at the University of Nottingham working in partnership with several Universities and NHS hospitals, has found that by interrupting the treatment of vulnerable people on long-term immune suppressing medicines for two weeks after a COVID-19 booster vaccination, their antibody response to the jab is doubled.

The Vaccine Response On Off Methotrexate (VROOM) trial was funded by the National Institute for Health and Care Research and the Medical Research Council, and run by the Oxford Clinical Trials Research Unit (OCTRU) at NDORMS. It was carried out in collaboration with colleagues from the University of Manchester, Imperial College London, the University of Oxford and Queen Mary University London.

The study will have implications for people on immune-supressing medicines, who are among the millions of clinically vulnerable patients advised to 'shield' during the pandemic.

The results of the study are published in The Lancet Respiratory Medicine.

Methotrexate is the most commonly used immune-suppressing drug, with around 1.3 million people in the UK prescribed this medicine for inflammatory conditions such as rheumatoid arthritis, and skin conditions such as psoriasis. Many of them were among the 2.2 million clinically extremely vulnerable people advised to shield during the first phase of the COVID-19 pandemic, depending on specialist advice and on their risk factors.

While methotrexate is effective at controlling these conditions and has emerged as first line therapy for many illnesses, it reduces the body's ability to fight infections and the ability to generate robust response to flu and pneumonia vaccines, including those against COVID-19.

The VROOM trial looked at the impact of interrupting methotrexate treatment for two-weeks after a COVID-19 booster vaccination on vaccine responses in adults with autoimmune inflammatory conditions.

After 4 weeks and 12 weeks, the spike-antibody level was more than two-fold higher in the group where methotrexate was suspended for two-weeks following vaccination, compared to the group who continued use. There was a worsening of disease control at week 4 in the suspend group, but that had normalised by week 12. There was no impact on quality of life or general health.

OCTRU Academic Lead, Associate Professor Jonathan Cook based at NDORMS at the University of Oxford said: "It's pleasing to see the difference that a simple, cheap and modest adjustment to treatment can make. Clinical trials like VROOM are needed to help us understand how best to deliver vaccinations like a COVID-19 booster in different patient groups."

The study planned to recruit 560 patients, but recruitment was stopped early by the independent study oversight committees when interim results from the first 254 participants showed a clear result.

Read the full story on the University of Nottingham website 

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