A new national trial is recruiting people with rare autoimmune diseases to measure their COVID-19 antibody response following at least 3 vaccinations.

The MELODY study (Mass evaluation of lateral flow immunoassays (at home finger prick antibody tests) for the detection of SARS-CoV-2 antibody responses in immunosuppressed people) has been launched this week to determine the antibody levels of immunocompromised people. It is very likely that some of the SRUK community with scleroderma will be contacted directly to ask if they will take part in this study.

What is MELODY aiming to find out?

Antibodies are complex molecules made by the immune system in response to infection, with the purpose of fighting the disease. In COVID-19, antibody levels are important, as scientists suspect that the higher a person’s antibody level, the better equipped they may be to fight off a COVID-19 infection. Previous studies like the MRC-funded OCTAVE study, showed that some people who were immunocompromised through their medical condition or the medications they take to manage their condition respond less effectively to COVID-19 vaccines, and producing much lower levels of antibodies following vaccination compared to ‘healthy’ controls. This has clear implications for those autoimmune conditions such as scleroderma. The MELODY study follows on this work by carrying out a largescale study to monitor antibody levels in these at-risk populations.  

The MELODY study aims to:

1.Assess how many immunocompromised people have detectable antibodies against COVID-19 following at least 3 vaccines.

Antibodies are specialised proteins which move around via your circulatory system and are specific to a unique disease-causing organism. They are created by your immune system in response to infection or vaccination, binding to the COVID-19 viral spike protein and ‘neutralising’ it. For more detail on exactly how your immune system fights COVID-19, take a look at this article.

The OCTAVE study showed that many individuals with autoimmune rheumatic diseases are classed as ‘low responders’ with lower antibody levels following two doses of COVID-19 vaccination when compared to the general population. MELODY will investigate whether this remains true following a third vaccine. 

2. Investigate whether a lack of detectable antibodies are associated with risk of infection over a 6-month period.

Anti-COVID antibodies naturally decline over time. This is why the booster program was so vital in all UK adults, as each person’s protection against COVID needed to be increased. With that being said, antibodies are not the only factor that can protect an individual against COVID. T-cellsare also key players in the fight against infection.

In this second aim, MELODY will examine whether, in absence of detectable antibodies, there may be other factors which protect immunosuppressed individuals against COVID-19 infection.

3. Investigate what factors are associated with lack of detectable antibodies in immunocompromised people

Within MELODY, researchers are particularly focused upon whether specific immunosuppressant medications can change an individual’s immune response to COVID-19 and its vaccinations. Perhaps unsurprisingly, the OCTAVE study showed that individuals taking certain immunosuppressants which suppress B cells (the cells which make antibodies) had reduced  COVID-19 specific antibody responses following vaccination.

Who will be asked to take part in MELODY?

The researchers responsible for MELODY have 36,000 home test kits available. They are aiming for 12,000 people with rare autoimmune rheumatic diseases who have received at least 3 vaccines to take part, and form a third of their cohort, with the remaining participants having other health conditions, such as a solid organ transplants. These individuals will be randomly selected and contacted by the study organisers directly. SRUK hope that this will include some of our community.

Recruitment to this important study will start around February 7^th  and is likely to take place over a few weeks.  

Participation is not mandatory, and if you are contacted you can decline the offer to take part. You can learn more about how people are selected and invited in The MELODY Study Fair Processing Notice

What will I have to do if I take part in MELODY?

Participation is very simple – just two online questionnaires and a finger-prick blood test which will allow your antibody levels to be tested. All can be done from the comfort of your own home.

Finger-prick test

This is a very easy, at home test which looks similar to a COVID-19 test kit, however in this case is a lateral flow antibody test. It can be completed independently, at home, and directly measures the levels of antibodies in your blood. The results are available within 15 minutes, however the researchers stress that the results are not 100% accurate, and should not be used to guide behaviour, i.e. they do not given an entirely accurate prediction of how protected from COVID-19 you may or may not be, therefore you should continue to follow all government guidance.

Surveys

In addition to the finger-prick test, participating in MELODY requires you to complete two short surveys, one before the test, and one afterwards. This will collect basic information about yourself, your household and your current health status.

If you would like to read any additional information on this study, the full details can be found on The MELODY study homepage.

This study is being run by doctors at Imperial College London, with support from the following organisations: NHS Digital, NHS Blood and Transplant, University of Southampton, University of Cambridge, University of Nottingham, and Ipsos (an independent research organisation).