Adaptive clinical trial of AZD7442 and SARS-CoV-2 vaccination in immunosuppressed patients highly vulnerable to infection with SARS-CoV-2 virus (RAPID-PROTECTION): protocol for a multicentre, interventional open-label, randomised controlled trial
Introduction Despite repeated vaccinations against SARS-CoV-2 virus, patients who are immunocompromised remain at very high risk of catching SARS-CoV-2 virus and becoming unwell. AZD7442 (Evusheld) is a long-acting monoclonal antibody treatment that has been shown in clinical trials to prevent SARS-...
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BMJ Publishing Group
2025-01-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/1/e084345.full |
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| author | Ernest Choy Kerenza Hood Emma Thomas-Jones Eleanor Barnes Keith Wilson Christian H Ottensmeier Debbie Harris Adrian Hill Mark Tuthill Richard Adams Catherine Porter Katie Ewer Sian Griffin Rebecca Tangney Joanne Euden Shirley Pringle Lawrence Raisanen Ruby Ray Lisette Sheena Nixon Melanie Varley Craig Bodman Paola Cicconi Vivien Dagley Steven Knapper |
| author_facet | Ernest Choy Kerenza Hood Emma Thomas-Jones Eleanor Barnes Keith Wilson Christian H Ottensmeier Debbie Harris Adrian Hill Mark Tuthill Richard Adams Catherine Porter Katie Ewer Sian Griffin Rebecca Tangney Joanne Euden Shirley Pringle Lawrence Raisanen Ruby Ray Lisette Sheena Nixon Melanie Varley Craig Bodman Paola Cicconi Vivien Dagley Steven Knapper |
| author_sort | Ernest Choy |
| collection | DOAJ |
| description | Introduction Despite repeated vaccinations against SARS-CoV-2 virus, patients who are immunocompromised remain at very high risk of catching SARS-CoV-2 virus and becoming unwell. AZD7442 (Evusheld) is a long-acting monoclonal antibody treatment that has been shown in clinical trials to prevent SARS-CoV-2 infection for up to a year after a single dose. Vaccines require a healthy immune system to generate protective immunity. AZD7442 may prevent SARS-CoV-2 infection in immunocompromised individuals that may not have responded to repeated vaccinations against SARS-CoV-2 virus. Unlike vaccinations, AZD7442 reaches effective levels within the body a few hours after a single dose. The RAPID-PROTECTION trial will determine the levels of immune protection that AZD7442 offers patients at the very highest risk of SARS-CoV-2 infection and whether this protection can be further enhanced by repeated vaccination against SARS-CoV-2 virus.Methods RAPID-PROTECTION is a multicentre, interventional and open-label adaptive platform trial that aims to recruit 350 immunocompromised participants across five UK centres. Participants will be administered AZD7442 on day 0 followed by a SARS-CoV-2 vaccination 28 days later. Participants will be randomised (1:1) to the Moderna vaccine or Pfizer/BioNTech vaccine. Participant samples will be taken at baseline and at multiple timepoints after the administration of AZD7442.Analysis The participant samples will be analysed to measure the function and magnitude of SARS-CoV-2 specific antibody and T-cell responses at baseline and at multiple timepoints after the administration of AZD7442. The immunological effect of the study interventions will be determined by comparison of the results of immunological assessments at baseline and subsequent timepoints.Ethics and dissemination The trial protocol was approved by the research ethics committee of the National Health Service (reference 22/HRA/0359), Health Research Authority and Health and Care Research Wales on 25 July 2022. Findings will be disseminated through peer-reviewed journals and presented at scientific conferences.Trial registration number ISRCTN53507177. |
| format | Article |
| id | doaj-art-6172c8aa93114539a6a89e86ad9697b9 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-6172c8aa93114539a6a89e86ad9697b92025-01-21T13:00:09ZengBMJ Publishing GroupBMJ Open2044-60552025-01-0115110.1136/bmjopen-2024-084345Adaptive clinical trial of AZD7442 and SARS-CoV-2 vaccination in immunosuppressed patients highly vulnerable to infection with SARS-CoV-2 virus (RAPID-PROTECTION): protocol for a multicentre, interventional open-label, randomised controlled trialErnest Choy0Kerenza Hood1Emma Thomas-Jones2Eleanor Barnes3Keith Wilson4Christian H Ottensmeier5Debbie Harris6Adrian Hill7Mark Tuthill8Richard Adams9Catherine Porter10Katie Ewer11Sian Griffin12Rebecca Tangney13Joanne Euden14Shirley Pringle15Lawrence Raisanen16Ruby Ray17Lisette Sheena Nixon18Melanie Varley19Craig Bodman20Paola Cicconi21Vivien Dagley22Steven Knapper23Division of Infection and Immunity, CREATE Centre, Cardiff University School of Medicine, Cardiff, UKCardiff University College of Biomedical and Life Sciences, Cardiff, UKCentre for Trials Research, Cardiff University College of Biomedical and Life Sciences, Cardiff, UKNuffield Department of Medicine, University of Oxford, Oxford, Oxfordshire, UKBlood and Bone Marrow Transplantation Department, Cardiff University, Cardiff, UKMolecular and Clinical Cancer Medicine, University of Liverpool, Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool, Wirral, UKCentre for Trials Research, Cardiff University College of Biomedical and Life Sciences, Cardiff, UKJenner Institute and Wellcome Human Genetics Centre, University of Oxford, Oxford, UKDepartment of Oncology, Oxford University Hospitals NHS Foundation Trust, Oxford, UKCentre for Trials Research, Cardiff University College of Biomedical and Life Sciences, Cardiff, UKCentre for Trials Research, Cardiff University College of Biomedical and Life Sciences, Cardiff, UKJenner Institute and Wellcome Human Genetics Centre, University of Oxford, Oxford, UKUniversity Hospital of Wales, Cardiff, UKPharmacy Department, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UKCentre for Trials Research, Cardiff University College of Biomedical and Life Sciences, Cardiff, UKLiverpool Head and Neck Centre Research Team, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UKCentre for Trials Research, Cardiff University College of Biomedical and Life Sciences, Cardiff, UKCentre for Trials Research, Cardiff University College of Biomedical and Life Sciences, Cardiff, UKCentre for Trials Research, Cardiff University College of Biomedical and Life Sciences, Cardiff, UKCentre for Trials Research, Cardiff University College of Biomedical and Life Sciences, Cardiff, UKCentre for Trials Research, Cardiff University College of Biomedical and Life Sciences, Cardiff, UKJenner Institute, University of Oxford, Oxford, UKPatient and Public Involvement representative, Centre for Trials Research, Cardiff University, Cardiff, UKDepartment of Haematology, Cardiff University School of Medicine, Cardiff, UKIntroduction Despite repeated vaccinations against SARS-CoV-2 virus, patients who are immunocompromised remain at very high risk of catching SARS-CoV-2 virus and becoming unwell. AZD7442 (Evusheld) is a long-acting monoclonal antibody treatment that has been shown in clinical trials to prevent SARS-CoV-2 infection for up to a year after a single dose. Vaccines require a healthy immune system to generate protective immunity. AZD7442 may prevent SARS-CoV-2 infection in immunocompromised individuals that may not have responded to repeated vaccinations against SARS-CoV-2 virus. Unlike vaccinations, AZD7442 reaches effective levels within the body a few hours after a single dose. The RAPID-PROTECTION trial will determine the levels of immune protection that AZD7442 offers patients at the very highest risk of SARS-CoV-2 infection and whether this protection can be further enhanced by repeated vaccination against SARS-CoV-2 virus.Methods RAPID-PROTECTION is a multicentre, interventional and open-label adaptive platform trial that aims to recruit 350 immunocompromised participants across five UK centres. Participants will be administered AZD7442 on day 0 followed by a SARS-CoV-2 vaccination 28 days later. Participants will be randomised (1:1) to the Moderna vaccine or Pfizer/BioNTech vaccine. Participant samples will be taken at baseline and at multiple timepoints after the administration of AZD7442.Analysis The participant samples will be analysed to measure the function and magnitude of SARS-CoV-2 specific antibody and T-cell responses at baseline and at multiple timepoints after the administration of AZD7442. The immunological effect of the study interventions will be determined by comparison of the results of immunological assessments at baseline and subsequent timepoints.Ethics and dissemination The trial protocol was approved by the research ethics committee of the National Health Service (reference 22/HRA/0359), Health Research Authority and Health and Care Research Wales on 25 July 2022. Findings will be disseminated through peer-reviewed journals and presented at scientific conferences.Trial registration number ISRCTN53507177.https://bmjopen.bmj.com/content/15/1/e084345.full |
| spellingShingle | Ernest Choy Kerenza Hood Emma Thomas-Jones Eleanor Barnes Keith Wilson Christian H Ottensmeier Debbie Harris Adrian Hill Mark Tuthill Richard Adams Catherine Porter Katie Ewer Sian Griffin Rebecca Tangney Joanne Euden Shirley Pringle Lawrence Raisanen Ruby Ray Lisette Sheena Nixon Melanie Varley Craig Bodman Paola Cicconi Vivien Dagley Steven Knapper Adaptive clinical trial of AZD7442 and SARS-CoV-2 vaccination in immunosuppressed patients highly vulnerable to infection with SARS-CoV-2 virus (RAPID-PROTECTION): protocol for a multicentre, interventional open-label, randomised controlled trial BMJ Open |
| title | Adaptive clinical trial of AZD7442 and SARS-CoV-2 vaccination in immunosuppressed patients highly vulnerable to infection with SARS-CoV-2 virus (RAPID-PROTECTION): protocol for a multicentre, interventional open-label, randomised controlled trial |
| title_full | Adaptive clinical trial of AZD7442 and SARS-CoV-2 vaccination in immunosuppressed patients highly vulnerable to infection with SARS-CoV-2 virus (RAPID-PROTECTION): protocol for a multicentre, interventional open-label, randomised controlled trial |
| title_fullStr | Adaptive clinical trial of AZD7442 and SARS-CoV-2 vaccination in immunosuppressed patients highly vulnerable to infection with SARS-CoV-2 virus (RAPID-PROTECTION): protocol for a multicentre, interventional open-label, randomised controlled trial |
| title_full_unstemmed | Adaptive clinical trial of AZD7442 and SARS-CoV-2 vaccination in immunosuppressed patients highly vulnerable to infection with SARS-CoV-2 virus (RAPID-PROTECTION): protocol for a multicentre, interventional open-label, randomised controlled trial |
| title_short | Adaptive clinical trial of AZD7442 and SARS-CoV-2 vaccination in immunosuppressed patients highly vulnerable to infection with SARS-CoV-2 virus (RAPID-PROTECTION): protocol for a multicentre, interventional open-label, randomised controlled trial |
| title_sort | adaptive clinical trial of azd7442 and sars cov 2 vaccination in immunosuppressed patients highly vulnerable to infection with sars cov 2 virus rapid protection protocol for a multicentre interventional open label randomised controlled trial |
| url | https://bmjopen.bmj.com/content/15/1/e084345.full |
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