A new study is recruiting more than 35,000 immunocompromised people to determine their immune response to Covid-19 vaccination and future risk of infection, hospitalisation and survival over six months.
The study, which involves researchers from the University of Nottingham, 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 six-month booster which they will receive after their third primary dose).
This new study aims to recruit more than 35,000 people who have received their 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 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 study co-investigator, said:"The third 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 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.
Recruitment of patients into the study will begin on November 15; researchers will be looking for patient cohorts who are one of the following:
- solid organ transplant recipients
- patients with autoimmune diseases receiving immunosuppression
- patients with blood cancer
The study will be 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. The Department of Health and Social Care (DHSC) are also project partners.
Dr Aisling McMahon, executive director of research, innovation and policy at Kidney Research UK said, "On behalf of all of the charity partners, we are thrilled to be supporting this important research to identify patients who remain unprotected after three doses of Covid-19 vaccine. While vaccination has demonstrated significant benefits in reducing risk for many patients, it is vital that we identify patients who are still vulnerable to Covid-19 to allow healthcare professionals to suggest alternative protective measures and to highlight those patients who may benefit from new prophylactic treatments."
