A new study being led by the University of Birmingham, University Hospitals Birmingham NHS Foundation Trust, and University College London aims to explore the immune response to natural COVID-19 infection and vaccination in patients with antibody deficiency.
Funded by UK Research and Innovation (UKRI) , ’COVID infection in patients with Antibody Deficiency’ (COVAD) is part of a portfolio of national studies examining the immune responses in patients considered at high risk of COVID-19.
Immunodeficiency patients are considered vulnerable or extremely vulnerable to COVID-19 infection and have had to undertake preventative measures to minimise their risk of exposure to the virus.
Patients with antibody deficiency do not make good responses - if any - to most vaccines, but it is not known whether they will respond to COVID-19 vaccines.
COVAD Chief Investigator Alex Richter , Professor of Clinical Immunology at the University of Birmingham, and Consultant Clinical Immunologist at University Hospitals Birmingham NHS Foundation Trust, said: "Nationally, a number of patients with immunodeficiency have had severe or prolonged illness with COVID-19. Understanding why some patients do well and others don’t is so important. Being unable to clear the virus is not just a problem to the patient but is potentially a public health problem too."
The researchers will be using Oxford Immunotec’s T-SPOT.COVID Test to test immunological responses. Samples will be taken from patients to measure the presence and level of antibodies in the blood and anti-SARS-CoV-2 T-cells.
The results of the research will be widely applicable to immunosuppressed patients and will help inform the development of vaccination strategies as well as strengthen the understanding of risk for continuous virus transmission.
Co-principal Investigator Siobhan Burns, Professor of Translational Immunology at University College London , added: "This study is part of the national effort to understand how well vaccines work in vulnerable patients. We are also looking for persistent viral infections in our patients to understand whether this drives viral mutation."
Professor Fiona Watt , Executive Chair of the Medical Research Council, part of UKRI, said: "This multi-partner study will explore a crucial area of COVID-19 research and tell us more about the immune response of immunodeficient individuals to natural COVID-19 infection and vaccination. The importance of this is two-fold: protecting some of the most vulnerable groups to severe effects of the disease, and understanding how the virus that causes COVID-19 may adapt within an individual who struggles to clear the virus."
Margaret Bennett, West Midlands Patient Representative Immunodeficiency UK, said: "It is important for vulnerable patients with immunodeficiencies to know if the COVID-19 vaccine offers them any protection."
Professor Sinisa Savic , Chair of the UK Primary Immunodeficiency Network, explained: "The findings of this study will be critical for developing future COVID-19 guidelines for care of patients with antibody deficiencies."
Dr Andrew Makin , VP of Medical Affairs at Oxford Immunotec, stated: "We are pleased to be partnering with the University of Birmingham on this clinical trial which will help characterize COVID-19 infection in patients with antibody deficiency. Measuring the T cell response in immune deficient patients will allow for a more comprehensive understanding of the immune response and signify the vital role T cells play in SARS-CoV-2 infection."
Professor Richter and Professor Burns are leading the COVAD research team at immunodeficiency centres at NHS hospital trusts across the UK, in what will be the largest study of its kind in this rare patient group world-wide.
The centres will screen patients and will invite those who are eligible and meet specific criteria to join the trial. If a patient is eligible for the study, their immunologist will be writing to them with more information. Those who have been written to who wish to take part in the study should call the number provided on their invitation letter, or they should inform the clinical team at their next immunology appointment that they would like to be considered for the COVAD study.
- The University of Birmingham is ranked amongst the world’s top 100 institutions, and its work brings people from across the world to Birmingham, including researchers and teachers and more than 6,500 international students from nearly 150 countries.
- Oxford Immunotec is a global, high-growth diagnostics company and part of the PerkinElmer group. We bring energy and invention to a world in need of diagnostic truth. We are uniquely placed as the only company in the world offering regulated ELISPOT assays for T cell measurement, with approval around the globe. Our leading product, the T-SPOT.TB test, is used for diagnosing infection with Tuberculosis, the world’s largest cause of death from infectious disease. The Company is an experienced manufacturer of IVD tests, operating under a fully audited Quality Management System, ensuring rigorous batch control. The company has manufactured in excess of 20 million clinical T cell tests for TB infection. The T-SPOT.TB test has been approved for sale in over 50 countries, including the United States (where it has received pre-market approval from the Food and Drug Administration), Europe (where it has obtained a CE mark), as well as Japan and China. The recently released T-SPOT.COVID test is CE marked in Europe for clinical use to understand the T cell immune response to SARS-CoV-2 infection and has been submitted to the FDA for emergency use authorization in the US (www.tspotcovid.com). The Company is headquartered near Oxford, UK. and in Marlborough, MA.
- Oxford Immunotec has been developing and strengthening its expertise in T cell measurement for over 18 years since the introduction of its T-SPOT technology in the field of TB diagnostics. In that time, we have taken the classic ELISPOT technique and developed it into the world leading proprietary T-SPOT technology platform we now use to measure T cell immune responses, improving performance, standardizing results, and streamlining the workflow. The ELISPOT technique is exceptionally sensitive since the target cytokine is captured directly around the secreting cell making ELISPOT assays much more sensitive than conventional ELISA assays. The test enumerates effector T cells responding to stimulation using two separate peptide pools measured in parallel in individual wells. T-SPOT.COVID antigen panels are designed as overlapping peptides spanning sequences of the Spike and Nucleocapsid proteins. This design offers maximum epitope coverage for enhanced detection of T cell reactivity and no HLA restrictions. Antigenic formulations of 253 peptides covering the most immunogenic regions of the virus genome allows measurement of the breadth of immunity and ensures the impact of point mutations is minimized. Specificity to SARS-CoV-2 has been enhanced by removing potentially cross-reactive peptide sequences with high homology to other coronaviruses. T-SPOT, T-Cell Xtend, T-SPOT Discovery SARS-CoV-2 and the Oxford Immunotec logo, are trademarks of Oxford Immunotec Limited.