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Sheffield: Researchers and clinicians from University of Sheffield And Sheffield University Hospitals NHS Foundation Trust are part of the ongoing Observational Cohort Trial-T-cells Antibodies and Vaccine Efficacy in SARS-CoV-2 (OCTAVE) trial, which is led by the Glasgow UniversitiesBirmingham and Oxford and a consortium of leading UK institutions.
Published in Nature Medicine, the latest report contains important new data on infection rates, disease severity and deaths in patient groups, which were studied up to a year after their first vaccination.
Preliminary data from the OCTAVE study from August 2021 showed that a significant proportion of clinically at risk patients with immunocompromised or immunosuppressed conditions showed a weak or undetectable immune response after two doses of the same vaccine against SARS-CoV- 2. Now, with new peer-reviewed data, researchers can share real-world infection results for this clinical risk group.
The study data covers the period from 2021 to mid-2022 and includes patients infected with Alpha, Delta and Omicron strains of SARS-CoV-2. The data do not estimate the impact of the third and fourth vaccinations, since offered to patients in the groups studied.
These new data show that, although in most groups of patients at risk, the COVID-19 infection rates were low, risk of SARS-CoV-2 severity and death was high in a subset of conditions, despite vaccination. This was particularly the case during the Delta wave. Furthermore, the data shows that while Omicron, now the dominant strain of SARS-CoV-2 worldwide, saw an increase in the rate of infection in at-risk patients, fewer of them fell severely. sick or have died.
OCTAVE (Observational Cohort Trial-T-cells Antibodies and Vaccine Efficacy in SARS-CoV-2) is a UK-wide multicentre trial led by the University of Glasgow, coordinated by the Clinical Trials Unit of the Cancer Research UK from the University of Birmingham and offered by a national consortium of leading academic and clinical centres. It was set up in the midst of the COVID-19 pandemic to assess, in real time, immune responses following vaccination against COVID-19 in patients with immune-mediated inflammatory diseases such as cancer, arthritis inflammatory disease, kidney or liver disease, or patients undergoing stem cell transplantation. Previously, preliminary data published by OCTAVE in 2021 showed that while most patients mounted a successful immune response after two doses of the vaccine, some patients with certain immunosuppressed conditions mounted a weak or undetectable immune response. The study found that, overall, 12% of patients in the trial did not develop antibodies, with a further 27% generating only low levels of antibodies. Some patients also did not generate adequate T-cell responses after vaccination. Vaccine failure rates were higher in certain subgroups, including patients with ANCA-associated vasculitis on rituximab, patients on hemodialysis and also on immunosuppressive therapy, and patients who received solid organ transplants.
The study used a variety of state-of-the-art immune tests performed on blood samples taken before and/or after COVID-19 vaccination, as well as data on patient infection and severity to better understand the real impact of a low vaccine response in these groups of patients.
In the UK, more than 60% of people aged over 65 were known to have one or more chronic conditions in 2019, while more than 12 million people aged 18-65 lived with a chronic condition for more of 12 months. Government estimates suggest that around 500,000 people suffer from immunosuppressive disease in the UK – a large group who could be at greater risk of serious COVID-19 infection if not fully protected by the vaccination.
Thushan de Silva, Professor, Infectious Diseases, University of Sheffield and Honorary Consultant Physician, Infectious Diseases, Sheffield Teaching Hospitals NHS Trust, added: “The OCTAVE study has demonstrated which patients may remain at higher risk of COVID-19 despite vaccination. and where we need to focus more effort to find ways to protect the most vulnerable groups in society.
John Snowden, Director of the Blood and Marrow Transplant Programme, Sheffield Teaching Hospitals NHS Trust and Honorary Professor at the University of Sheffield, said: “Patients who have received various forms of treatment for blood cancers, including including bone marrow transplantation and CAR-T therapy, are particularly susceptible to developing serious complications from COVID-19 infection, but many respond poorly to vaccination.
“The OCTAVE study has provided major insights into how best to identify the most vulnerable patients and protect them as much as possible from serious complications.
“In collaboration with many national teams, the Sheffield team led the section of the OCTAVE study focusing on bone marrow transplantation and CAR-T patients and were the largest recruiters of patients in this high-potential cohort. risk. We sincerely thank all the patients and staff involved in this great achievement.
The OCTAVE trial is one of the world’s largest studies to date of post-SARS-CoV-2 vaccination in immunocompromised patients and is funded by the Medical Research Council (MRC).
Professor Iain McInnes, OCTAVE Trial Leader, and Vice-Principal and Director of the College of MVLS, University of Glasgow, said: “The OCTAVE study has provided vital information on the efficacy of vaccines against SARS. -CoV-2 in some of our most vulnerable patients. patient groups. Key strengths of the study include identifying the small number of patients who may not respond to vaccines, allowing healthcare providers and policy makers to make the best decisions to protect these groups of people. Importantly, the study was also able to reassure us that the majority of our immunocompromised patients in the UK were protected against severe COVID-19 through the vaccination programme.
Professor Pamela Kearns, Head of Clinical Trials Unit, Cancer Research UK, University of Birmingham, said: “OCTAVE provides important understanding of how vaccines have provided protection to many of the most vulnerable groups in the world. clinically, and how disease variants have affected their effectiveness. .
“We can see that there are areas of particular concern where vaccines have not adequately protected against COVID-19, including some patients with kidney disease and certain inflammatory conditions.”
“We are extremely grateful to all of these participants and to each of the centers that participated for giving us the clearest picture yet of how the most clinically vulnerable have been protected and where the pain points need to be. be corrected.”
Professor Eleanor Barnes, Professor of Hepatology and Experimental Medicine, Nuffield Department of Medicine, University of Oxford, said: “Importantly, T cell and antibody responses to vaccines have been shown to be effective in protecting against severe disease in immunocompromised patients.”
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