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 threevaccines 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:[email protected] or to find our more, please visit the study website: www.melodystudy.org.
