Researchers in Nottingham today launch a major clinical trial investigating whether some of the 1.3 million most vulnerable people on long-term immune suppressing medicines can mount a more robust immune response to COVID-19 booster jabs by interrupting their treatment for two weeks after vaccination.
The VROOM trial, which will have implications for people on immune-suppressing medicines, who are among the millions of clinically vulnerable patients advised to ‘shield’ during the pandemic – is funded by the National Institute for Health Research (NIHR) and the Medical Research Council (MRC), and will be led by a team based at the University of Nottingham and NUH.
Approximately 1.3 million people in the UK are prescribed the immune-suppressing drug called 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 fight infections and the ability to generate robust response 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.
Better immunity usually means a better chance of avoiding infection in the first place, and fighting the virus if people are infected. Statistics show that people with inflammatory conditions are 1.2 to 1.3 times more likely to die or be hospitalised from COVID-19.
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. This means that during the COVID-19 vaccine rollout specialists across the world have given conflicting advice that has confused patients.
The COVID-19 booster jab rollout gives an opportunity to answer this question.
Chief Investigator Professor Abhishek, Professor of Rheumatology, the University of Nottingham and Honorary Consultant Rheumatologist Nottingham University Hospitals NHS Trust (pictured), 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 flare-up of their long-term illness which affects their daily lives so heavily.
“Many people take methotrexate for more than 10-20 years, so we hope to provide high quality evidence which can help them with their day to day lives going forward.”
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 .
“Once again NIHR is providing a critical role in the fight against COVID-19, funding ground-breaking research, while volunteers are participating in trials to help us learn more and ultimately beat the virus.”
NIHR - the research partner of the NHS, public health and social care - and the MRC have jointly funded over £900,000 for the study through the Efficacy and Mechanism Evaluation (EME) Programme.
The study is being delivered in partnership with Oxford Clinical Trials Research Unit (OCTRU), Oxford University and is running in over 20 hospitals in the UK, supported by the NIHR’s Clinical Research Network (CRN).
More information on the study 'VROOM: Vaccine response on/off methotrexate’; Does temporarily suspending methotrexate treatment for two weeks enhance COVID-19 vaccine response? A randomised controlled trial' is available on the NIHR’s Funding and Awards website, and on the study website.