Researchers in centres from the universities of Oxford, Birmingham, Southampton and Imperial University will conduct a study to find out which immunosuppressed people have the greatest risk of COVID-19 infection. The STRAVINSKY study will recruit 3,000 patients with the impaired immune system; of which 2,600 will receive finger-prick antibody tests, whilst the remaining 400 will get more comprehensive immune analyses.
Researchers hope that the findings from this study will provide clinicians, policymakers, patients and the general public with detailed and up-to-date data on the impact of booster vaccinations.
Professor Eleanor Barnes, Professor of hepatology and experimental medicine at the Nuffield Department of Medicine, is leading the University of Oxford part of the study, looking at patients at Oxford University Hospitals (OUH). She said: “We know that COVID-19 infections disproportionately affect those with weakened immune systems. While most of the population seems to have moved on from the pandemic, these many of these patients are still shielded.
“STRAVINSKY aims to help us identify which individuals and patient groups are most clinically vulnerable to COVID-19 infection. We hope that, at the end of the study, our findings will inform future guidance for immunocompromised patients – we want to be able to reassure those who fear they are at high risk from COVID-19 but may not be, and to pinpoint those who remain extremely vulnerable to the virus.”
The University of Oxford researchers, who are supported by the NIHR Oxford Biomedical Research Centre, have already been involved in similar national clinical trials: The OCTAVE study found that a significant proportion of immunocompromised patients mount a low or undetectable immune response after two doses of the same COVID-19 vaccine. OCTAVE DUO has been investigating whether a third dose will improve this immune response.
Meanwhile, the PITCH study has been looking at how the immune system responds to the COVID-19 virus in healthcare workers. The data from this study will serve as a control in the STRAVINSKY study.
There are two main elements to the STRAVINSKY study: a retrospective analysis of all the UK studies that have already been carried out in this area so that it can be better understood who is still at risk, and a prospective study - led by the University of Oxford and the University of Southampton - where patients are followed over the next two years and their response to the new bivalent vaccines will be investigated.
Professor Barnes said: “We’re delighted to be able to employ Oxford’s expertise in T cell and antibody analysis and serology to help these vulnerable patients as part of the STRAVINSKY study, just as we have done in the OCTAVE and PITCH studies.”
“We will be looking specifically at whether we can use antibody testing and T cell responses to inform clinical risk so that patients know if they are still at risk or not. We hope that, at the end of the study, our findings will inform future guidance for immunocompromised patients.
In previous studies, Oxford researchers have focused on patients with liver, inflammatory bowel disease and stem cell transplants; as part of the STRAVINSKY study they are interested in recruiting patients from 22 different groups, including chronic lymphoproliferative disorders, plasma cell disorders, myelodysplastic syndrome or myeloproliferative neoplasm, common variable immunodeficiency and secondary antibody deficiency. The trial extends to people with conditions that do not require immunosuppressive drugs but are known to be at risk of severe COVID-19.
Professor Lucy Chappell, National Institute for Health and Care Research (NIHR) Chief Executive and Chief Scientific Advisor for the Department of Health and Social Care said: “This study will help to understand how different patient groups with weakened immune systems respond to COVID-19, including new variants, and vaccination.
“We hope that it will inform the development of more specific advice and help people understand their levels of risk, based on better information from antibody levels.”
Dr Mary Ramsay, Head of Immunisation at the UK Health Security Agency added: “Studies of COVID-19 immunity have been vital in helping us to understand how best to use vaccination in this vulnerable population, alongside real-world evidence on protection. We look forward to seeing the results of this antibody testing study.
“Vaccines remain the best way to protect yourself against serious infections, including COVID-19, and those eligible are urged to accept all the vaccines and boosters they are recommended – including the families of people with weakened immune systems.”
This two-year study has been supported with funding of 2.8m from the NIHR.