Tuesday, 08 February 2022
A new study, involving researchers from the University of Nottingham, is recruiting more than 35,000 immunocompromised people to determine their immune response to the Covid-19 vaccination and future risk of infection, hospitalisation and survival over six months.
The MELODY study will use data held by the National Disease Registration Service at NHS Digital, and 12,000 people with rare autoimmune diseases and 12,000 people with blood cancers will be invited to participate in the study. The study is already open to people who have had organ transplants.
This is the first time people with rare diseases registered with the National Disease Registration Service have been invited to take part in research. It has been made possible by work done by the RECORDER project, a collaboration between the University of Nottingham, Nottingham University Hospitals NHS Trust and the National Disease Registration Service at NHS Digital. This is an example of pioneering research in rare diseases, and is helping to deliver the ambitions of the UK Rare Diseases Framework.
The research aims to inform vaccination strategies and identify those who could benefit from other interventions such as monoclonal antibodies or other prophylactic therapies.
It is being funded by the Medical Research Council in collaboration with several health charities including Kidney Research UK, Blood Cancer UK, Vasculitis UK, and the Cystic Fibrosis Trust, and it will be led by researchers at Imperial College London.
Immunocompromised people tend to be the least likely to develop an antibody response following vaccination against Covid-19, but within this cohort there are huge variations between individuals and different immune conditions.
Evidence has shown overall that this group is more likely to have severe infection with increased morbidity and mortality, even following two doses of Covid-19 vaccines, and therefore may remain unprotected from Covid-19. As a result, this group of patients has been advised to receive a third primary dose of vaccine (as opposed to the standard booster which they will receive three months after their third primary dose).
This study aims to recruit more than 35,000 people who have received at least three vaccines and follow them for six months to investigate:
- the proportion of immunosuppressed patients who have detectable Covid-19 antibodies following three doses of Covid-19 vaccines
- whether a lack of an antibody response correlates with the subsequent risk of Covid-19 infection and severity of the disease
Findings from the study will be used for the development of effective protection and management strategies of Covid-19 infection in the 500,000 immunosuppressed people in the UK. The data will also help to inform whether immunocompromised people should be prioritised for alternative treatments like monoclonal antibodies to provide passive immunity.
Dr Fiona Pearce, University of Nottingham co-investigator for the study said “The MELODY study (Mass evaluation of lateral flow immunoassays in detecting antibodies to SARS-CoV-2) aims to assess the effectiveness of three doses of Covid-19 vaccination among immunosuppressed people in the community.
This is incredibly important because we know that some people who are immunosuppressed due to autoimmune diseases, blood cancers and organ transplant may not develop antibodies as well as the rest of the population to vaccination, and we need to know whether they develop antibodies after 3 or more doses, and their rates of infection, and severe outcomes from COVID-19 to inform vaccination strategies and identify those who could benefit from other interventions such as monoclonal antibodies or other prophylactic therapies”
Dr Peter Lanyon, Consultant Rheumatologist at Nottingham University Hospitals and national clinical lead for rare diseases at the National Disease Registration Service, said:"The third and fourth vaccine dose roll-out was welcome news for people who are immunosuppressed and who have a weakened immune system as a result of their health condition. However, some people may still not mount an immune response to vaccination even after three or four doses, and will therefore remain at high risk of serious outcomes from COVID-19 infection.
“The MELODY study is focused on this population and will provide vital information to enable us to come up with new approaches to protect the health of people who remain incompletely protected after vaccination."
The research will complement findings from the OCTAVE and OCTAVE DUO trials.
New patient cohorts are being invited now, who are one of the following:
- patients with autoimmune diseases receiving immunosuppression
- patients with blood cancer
- The recruitment of patients with solid organ transplant recipients into the study began on December 8 2021;
The study is a collaborative team effort consisting of 11 investigators across several institutions** with key partner support from NHS Digital, NHS Blood and Transplant, Kidney Research UK, Blood Cancer UK, Vasculitis UK and the Cystic Fibrosis Trust who will work in close collaboration with patient groups throughout the study.
Anyone wishing to enquire about participating in the study, should email the study:firstname.lastname@example.org or to find our more, please visit the study website: www.melodystudy.org.
** The multidisciplinary team overseeing the delivery of this study consists of investigators across several institutions (Imperial College London, University of Nottingham, University of Southampton, University of Cambridge and NHS Blood and Transplant).
The study will be launched with over £850,000 of funding from the Medical Research Council - including £200,000 from the charity partners.
The study aims to recruit people who are immunosuppressed including solid organ transplant recipients, people with blood cancer and people with autoimmune diseases receiving immunosuppression.
The Medical Research Council is at the forefront of scientific discovery to improve human health. Founded in 1913 to tackle tuberculosis, the MRC now invests taxpayers’ money in some of the best medical research in the world across every area of health. Thirty-three MRC-funded researchers have won Nobel prizes in a wide range of disciplines, and MRC scientists have been behind such diverse discoveries as vitamins, the structure of DNA and the link between smoking and cancer, as well as achievements such as pioneering the use of randomised controlled trials, the invention of MRI scanning, and the development of a group of antibodies used in the making of some of the most successful drugs ever developed. Today, MRC-funded scientists tackle some of the greatest health problems facing humanity in the 21st century, from the rising tide of chronic diseases associated with ageing to the threats posed by rapidly mutating micro-organisms.
UK Research and Innovation (UKRI) is the largest public funder of research and innovation in the UK, with a budget of around £8bn. It is composed of seven disciplinary research councils, Innovate UK and Research England. We operate across the whole country and work with our many partners in higher education, research organisations businesses, government, and charities.
Our vision is for an outstanding research and innovation system in the UK that gives everyone the opportunity to contribute and to benefit, enriching lives locally, nationally and internationally.
Our mission is to convene, catalyse and invest in close collaboration with others to build a thriving, inclusive research and innovation system that connects discovery to prosperity and public good.
NHS Blood and Transplant is a joint England and Wales Special Health Authority. We provide the blood donation service for England and the organ donation service for the UK. We also provide donated tissues, stem cells and cord blood. We are an essential part of the NHS, saving and improving lives through public donation.
Kidney Research UK is the largest kidney research charity in the UK, nothing is going to stop us in our urgent mission to end kidney disease. We’re here to be heard, to make a difference, to change the future. This is a disease that ruins and destroys lives. It must be stopped. Over the past 60 years, our research has made an impact. But kidney failure is rising, as are the factors contributing to it, such as diabetes and obesity. Today, we are more essential than ever.
Kidney disease affects three million people in the UK, treatments can be gruelling and currently there is no cure. Only research will end this. https://kidneyresearchuk.org/
The Cystic Fibrosis Trust is the only UK-wide charity dedicated to fighting for a life unlimited for everyone affected by cystic fibrosis. There are over 10,655 people with cystic fibrosis living in the UK and the population is growing every year. Visit www.cysticfibrosis.org.uk to find out more about cystic fibrosis, the work of the Trust and how you can help our fight for a life unlimited.
The National Disease Registration Service (NDRS) is part of NHS Digital (NHSD). Its purpose is to collect, collate and analyse data on patients with cancer, congenital anomalies, and rare diseases. It provides robust surveillance to monitor and detect changes in health and disease in the population. NDRS is a vital resource that helps researchers, healthcare professionals and policy makers make decisions about NHS services and the treatments people receive. It includes the National Cancer Registration and Analysis Service (NCRAS) and the National Congenital Anomaly and Rare Disease Registration Service (NCARDRS.) Healthcare professionals, researchers and policy makers use data to better understand population health and disease. The data is provided by patients and collected by the NHS as part of their care and support.
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The University of Nottingham is a research-intensive university with a proud heritage. Studying at the University of Nottingham is a life-changing experience, and we pride ourselves on unlocking the potential of our students. We have a pioneering spirit, expressed in the vision of our founder Sir Jesse Boot, which has seen us lead the way in establishing campuses in China and Malaysia - part of a globally connected network of education, research and industrial engagement. Ranked 18th in the UK by the QS World University Rankings 2023, the University’s state-of-the-art facilities and inclusive and disability sport provision is reflected in its crowning as The Times and Sunday Times Good University Guide Sports University of the Year twice in three years, most recently in 2021. We are ranked seventh for research power in the UK according to REF 2021. We have six beacons of research excellence helping to transform lives and change the world; we are also a major employer and industry partner - locally and globally. Alongside Nottingham Trent University, we lead the Universities for Nottingham initiative, a pioneering collaboration which brings together the combined strength and civic missions of Nottingham’s two world-class universities and is working with local communities and partners to aid recovery and renewal following the COVID-19 pandemic.