Dr Mark Tuthill (University of Oxford)- Opinion Editorial (UK COVID/cancer student leads)
People in the UK with impaired immune systems will have the opportunity to take part in a clinical trial investigating COVID-19 vaccinations in combination with Evusheld, a new antibody treatment used for the prevention of COVID-19 infection.
The RAPID-PROTECTION study opened to recruitment this week and is being conducted in a number of UK sites.
Despite repeated vaccinations against COVID-19, some people with weakened immune systems – caused by cancer, inflammatory conditions, as a result of organ transplants or other serious health conditions – remain at high risk of catching COVID-19 and becoming unwell.
Evusheld is a combination of two long-acting antibodies that bind to the spike protein on the outside of the SARS-CoV2 virus and prevents the virus from entering human cells.
It has been shown in clinical trials to prevent COVID-19 infection for up to a year after a single dose of two injections, giving protection within a few hours.
Unlike vaccines, Evusheld does not depend on a healthy immune system to generate protective immunity. Although Evusheld is known to be effective against the Omicron variant, it is not yet known how long this protection lasts.
This Phase II clinical trial will assess Evusheld in combination with the Pfizer BioNTech and Moderna COVID-19 vaccines in immunocompromised individuals.
This comes after the Medicines and Healthcare products Regulatory Agency (MHRA) approved the use of Evusheld in March 2022, after the treatment was deemed to meet UK regulatory standards of safety, quality and effectiveness. The Department of Health and Social Care has requested NICE to further evaluate cost-effectiveness in the context of the Omicron variant prior to making a decision on the procurement of Evusheld in the UK.
Approximately 350 participants will be recruited across the UK for the RAPID-PROTECTION study. Volunteers must be 18 years or over and have an impaired immune system.
Everyone taking part in the study will receive an injection of Evusheld, followed four weeks later by a vaccination. They will then have regular blood tests over the course of the following year to assess their levels of immune protection.
The study, which is sponsored by the Centre for Trials Research at Cardiff University, will be led by Oxford University Hospitals (OUH) NHS Foundation Trust, in collaboration with the University of Oxford.
The trial is open to recruitment at Oxford University Hospitals NHS Foundation Trust, The Royal Marsden Hospital (Sutton), and Northampton General Hospital. The research team are also aiming to open recruitment at Clatterbridge Cancer Centre (Liverpool) and University Hospital of Wales (Cardiff) in December 2022 or January 2023.
The RAPID-PROTECTION study will offer patients that remain vulnerable to COVID-19 despite vaccination Evusheld, a medicine that prevents COVID-19 in healthy unvaccinated people. We will test the level of immune protection that the treatment offers to vulnerable patients, and whether this protection can be improved by a repeat COVID-19 vaccination.Dr Mark Tuthill, Chief Investigator of the RAPID-PROTECTION study and Consultant Medical Oncologist at OUH
Dr Emma Thomas-Jones, Deputy Director of Infections, Inflammation and Immunity Trials at the Centre for Trials Research at Cardiff University said: “Our team at the Centre for Trials Research are delighted to be working in partnership with colleagues in Oxford on this important treatment trial for the prevention of serious COVID-19 infection in immunocompromised patients. These patients have been shielding for over two years, and hopefully this treatment, in conjunction with the COVID-19 vaccine roll-out, will be beneficial for them. It is vital that research like this is conducted to help find new ways to protect these patients from COVID-19.”
Those interested in taking part in the trial who meet the eligibility criteria can find out more at: https://www.rapid-protectionstudy.co.uk.
Participants must be willing to attend hospital for a total of seven visits throughout the study. Reasonable travel expenses will be reimbursed. This clinical trial would not be suitable for anyone pregnant or intending to become pregnant in the next year.