Major COVID-19 booster trial looks at how best to improve immunity against coronavirus in vulnerable people

Researchers have launched a major clinical trial investigating whether people on long-term immune-suppressing medicines can mount a more robust immune response to COVID-19 booster jabs by interrupting their treatment.

The VROOM trial will have implications for people on immune-suppressing medicines, who are among the millions of clinically vulnerable patients advised to ‘shield’ during the pandemic. The study is funded by an NIHR and the Medical Research Council (MRC) partnership, and led by a team at the University of Nottingham.

Approximately 1.3 million people in the UK are prescribed the immune-suppressing drug methotrexate 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 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 generate robust responses to flu and pneumonia vaccines.

Researchers will recruit 560 patients currently taking methotrexate, to investigate whether taking a two week break in this drug immediately after they receive the COVID-19 booster jab improves their immune response to vaccination, while preventing 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.

Professor Andy Ustianowski, NIHR Clinical Lead for the COVID-19 Vaccination Programme and Joint National Infection Specialty Lead, said: “Although the vaccine rollout has saved many lives and helped drive down the effects of the pandemic, there are still groups of vulnerable people who can’t always mount robust immunity against the virus. "

“It’s important to establish if people can safely improve protection from their booster jabs by taking a break from their immune-supressing medicines, and this pivotal study will help develop our understanding of immune responses in people taking this widely prescribed medicine."

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Source: NIHR, 12 November 2021