VROOM: Vaccine Response On/Off Methotrexate [COVID-19]
Research type
Research Study
Full title
A multi-centre randomised controlled trial examining the effects of temporarily suspending low-dose methotrexate treatment for two weeks after SARS-CoV-2 vaccine booster on vaccine response in immunosuppressed adults with inflammatory conditions, including a nested mechanistic sub-study
IRAS ID
303827
Contact name
Abhishek Abhishek
Contact email
Sponsor organisation
University of Nottingham
ISRCTN Number
ISRCTN11442263
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
The purpose of the VROOM study is to find out if an individual’s response to a vaccine can be improved. Specifically the VROOM study will aim to recruit individuals who have inflammatory conditions such as rheumatoid arthritis and psoriasis and routinely take a drug called methotrexate. The individuals needed for the study are these individuals and specifically those who are invited to and accept an invitation to have a booster vaccination against COVID-19 from the NHS vaccination programme.
Doctors and scientists believe there is a small amount of evidence that if individuals temporarily stop taking their methotrexate for the two weeks around when they receive their COVID-19 booster- it may improve their body’s (immune) response. The study will also help understand the way in which methotrexate dampens the immune response to vaccines.
Methotrexate is the first-line treatment for inflammatory conditions such as rheumatoid arthritis and psoriasis. It does a good job at controlling such diseases but it also reduces the body’s ability to fight infections. People taking methotrexate also don’t get great responses to vaccines such as those
against the flu and pneumonia. Better immunity usually means a better chance of not getting infected and fighting the virus if infected. Because there is no clear evidence on whether to halt or continue methotrexate during COVID-19 vaccinations, specialists have given conflicting advice that has confused patients. There is an opportunity to answer this question during the booster vaccinations in winter 2021.We will invite 560 people with inflammatory conditions such as rheumatoid arthritis and psoriasis receiving methotrexate to take part in our study looking at vaccine response in those who continue to take their methotrexate as usual or who take a 2 week break from taking their methotrexate around their COVID-19 booster vaccination.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
21/YH/0209
Date of REC Opinion
23 Aug 2021
REC opinion
Favourable Opinion