The FINANCIAL — A new national study is recruiting immunocompromised people to determine their immune response to COVID-19 vaccination over six months.
According to UKRI, the study is recruiting more than 35,000 immunocompromised people to work out their immune response to COVID-19 vaccination and future risk of infection, hospitalisation and survival over a six-month period.
The study 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 (MRC) in collaboration with several health charities including:
Kidney Research UK
Blood Cancer UK
Cystic Fibrosis Trust.
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. This was extended to a fourth vaccine dose three months after the third dose in an announcement last week.
This new study aims to recruit more than 35,000 people who are at least 21 days following their third vaccine dose, 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.
The study will be investigating solid organ transplant recipients, people with blood cancer and people with rare autoimmune conditions receiving immunosuppression.
The study will open to recruit transplant recipients in the first instance, followed by the other patient groups in the near future. Transplant recipients may self-register on MELODY study.
The MELODY study
Dr Michelle Willicombe, study lead said:The Mass evaluation of lateral flow immunoassays in detecting antibodies to SARS-CoV-2 (MELODY) study aims to assess the antibody status of immunocompromised people in the community who have received at least three vaccines.
It builds on the experience of the REACT2 study, but focuses on a population who are in need of bespoke COVID-19 protection strategies. As well as antibody testing, the study will capture information on clinical and social factors, which will enable the identification of those immunocompromised patients who are most at risk.
Professor Fiona Watt, Executive Chair of MRC said: This new research, funded by MRC in partnership with others, will examine how best to protect people with impaired immune systems from developing COVID-19.
People are now receiving their third doses of COVID-19 vaccines, and very shortly their fourth. This time-critical research will assess their antibody responses and how they impact on hospitalisation and survival.
The research will complement findings from the OCTAVE and OCTAVE DUO trials.
The study will be a collaborative team effort consisting of 11 investigators across several institutions with key partner support from:
Department of Health and Social Care (DHSC)
NHS Blood and Transplant (NHSBT)
Kidney Research UK
Blood Cancer UK
Cystic Fibrosis Trust who will work in close collaboration with patient groups throughout the study.
New prophylactic treatments
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.
UK transplant population
Professor Gavin Pettigrew, Chair of NHSBT Research Innovation and Novel Technology Advisory Group said: Our ongoing registry analysis of SARS-CoV-2 infection in the UK transplant population has highlighted that protection following two COVID-19 vaccines is much weaker when compared to the general population.
In order to determine how to best protect our patients, it is therefore extremely important that we assess the response following the third and further vaccines.
Third dose COVID-19 vaccine
Louise Carten, 40, from Glasgow, who has polycystic kidney disease (PKD) said:
When lockdown began, I stopped work in the neo natal unit at Crosshouse Hospital, Kilmarnock, and shielded for six months.
Since August 2020 I’ve worked from home for the Track and Protect unit for Ayrshire and Arran NHS Trust, which my renal consultant and my renal nursing manager are quite happy with. I miss the babies and the camaraderie of my work colleagues. I just want to get back to normal.
I had my blue letter from the government a couple of weeks ago and have now had my third dose COVID-19 vaccine, along with my seasonal flu jab, according to University of Oxford.
After going through the anxiety of living through the pandemic and watching my family worry for me, I want to know whether the third dose of the vaccine has had a positive effect. Am I now as well protected as the general population? If not, what other treatments could help protect me?
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