{"id":2401,"date":"2021-02-02T09:54:27","date_gmt":"2021-02-02T09:54:27","guid":{"rendered":"https:\/\/mft.nhs.uk\/wythenshawe\/mft-recruits-final-participant-to-phase-3-covid-19-vaccine-study\/"},"modified":"2021-02-02T09:57:35","modified_gmt":"2021-02-02T09:57:35","slug":"mft-recruits-final-participant-to-phase-3-covid-19-vaccine-study","status":"publish","type":"post","link":"https:\/\/mft.nhs.uk\/wythenshawe\/mft-recruits-final-participant-to-phase-3-covid-19-vaccine-study\/","title":{"rendered":"MFT recruits final participant to Phase 3 COVID-19 vaccine study"},"content":{"rendered":"<p><a href=\"https:\/\/mft.nhs.uk\/\">Manchester University NHS Foundation Trust (MFT)<\/a>, England\u2019s largest NHS trust, has recruited its final participant to a leading COVID-19 vaccine trial.<\/p>\n<p>The Phase 3 study is testing the safety and effectiveness of a new <strong>two-dose<\/strong> vaccine regimen, versus a placebo, in preventing moderate to severe\/critical coronavirus disease.<\/p>\n<p>The vaccine candidate has been developed by <a href=\"https:\/\/www.janssen.com\/\">The Janssen Pharmaceutical Companies of Johnson &amp; Johnson<\/a>, as researchers around the world continue to work to secure a range of vaccines and treatments to help tackle coronavirus.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignright size-medium wp-image-2406\" src=\"https:\/\/mft.nhs.uk\/app\/uploads\/sites\/10\/2021\/02\/Claire-dose-close-up-300x225.jpg\" alt=\"\" width=\"300\" height=\"225\" srcset=\"https:\/\/mft.nhs.uk\/app\/uploads\/sites\/10\/2021\/02\/Claire-dose-close-up-300x225.jpg 300w, https:\/\/mft.nhs.uk\/app\/uploads\/sites\/10\/2021\/02\/Claire-dose-close-up-1024x768.jpg 1024w, https:\/\/mft.nhs.uk\/app\/uploads\/sites\/10\/2021\/02\/Claire-dose-close-up-768x576.jpg 768w, https:\/\/mft.nhs.uk\/app\/uploads\/sites\/10\/2021\/02\/Claire-dose-close-up-1536x1152.jpg 1536w, https:\/\/mft.nhs.uk\/app\/uploads\/sites\/10\/2021\/02\/Claire-dose-close-up-60x45.jpg 60w, https:\/\/mft.nhs.uk\/app\/uploads\/sites\/10\/2021\/02\/Claire-dose-close-up-680x510.jpg 680w, https:\/\/mft.nhs.uk\/app\/uploads\/sites\/10\/2021\/02\/Claire-dose-close-up.jpg 2016w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/>Dr Claire Cole (right), the Head of Research Delivery at MFT, was the <a href=\"https:\/\/mft.nhs.uk\/2020\/11\/20\/mft-hero-is-the-first-person-in-the-world-to-be-consented-into-a-new-phase-3-covid-19-vaccine-study\/\">first person in the world to be consented into the Janssen trial when it opened on 16 November 2020<\/a>.<\/p>\n<p>MFT has now recruited 405 participants to the study, exceeding its target of 400 within just eight weeks. Globally, recruitment into the study is due to complete in March 2021, with 6,000 volunteers taking part in the UK and 30,000 worldwide.<\/p>\n<p>Dr Cole said: \u201cAlthough I have worked in health research for a number of years, I never cease to be amazed by the life-changing \u2013 and sometimes lifesaving \u2013 impact research can have.<\/p>\n<p>\u201cI wholeheartedly believe in the importance of taking part in research and was honoured to be the first person in the world to be recruited to the study, as part of this vitally important COVID-19 vaccine trial.<\/p>\n<p>\u201cBut I am especially proud of the resilience of the multidisciplinary study team here at MFT, who have managed to recruit the required number of participants and start administering second doses within just two months \u2013 an incredible achievement considering the current global landscape.\u201d<\/p>\n<p>Across the UK, volunteers from a variety of age groups and backgrounds \u2013 including some of the thousands who registered to be contacted about vaccine studies through the <a href=\"https:\/\/www.nhs.uk\/conditions\/coronavirus-covid-19\/research\/coronavirus-vaccine-research\/\">NHS COVID-19 Vaccine Research Registry<\/a> \u2013 have been taking part in the study.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignright size-medium wp-image-2408\" src=\"https:\/\/mft.nhs.uk\/app\/uploads\/sites\/10\/2021\/02\/stephanie_gill1-289x300.jpg\" alt=\"\" width=\"289\" height=\"300\" srcset=\"https:\/\/mft.nhs.uk\/app\/uploads\/sites\/10\/2021\/02\/stephanie_gill1-289x300.jpg 289w, https:\/\/mft.nhs.uk\/app\/uploads\/sites\/10\/2021\/02\/stephanie_gill1-985x1024.jpg 985w, https:\/\/mft.nhs.uk\/app\/uploads\/sites\/10\/2021\/02\/stephanie_gill1-768x798.jpg 768w, https:\/\/mft.nhs.uk\/app\/uploads\/sites\/10\/2021\/02\/stephanie_gill1-60x62.jpg 60w, https:\/\/mft.nhs.uk\/app\/uploads\/sites\/10\/2021\/02\/stephanie_gill1-680x707.jpg 680w, https:\/\/mft.nhs.uk\/app\/uploads\/sites\/10\/2021\/02\/stephanie_gill1.jpg 1250w\" sizes=\"auto, (max-width: 289px) 100vw, 289px\" \/>Stephanie Gill (right), a headteacher, was contacted to take part in the study at MFT after signing up to the vaccine registry.<\/p>\n<p>The 51-year-old from Sale, Manchester, said: \u201cWhen I received my invite to take part, I was really excited.<\/p>\n<p>\u201cI\u2019ve never taken part in research before, but all the research staff here have been absolutely brilliant.\u201d<\/p>\n<p>Having now received two doses as part of the blind study, Stephanie does not know whether she received the vaccine candidate or the placebo.<\/p>\n<p>\u201cWhile I of course hope I received the vaccine, the blind element is the whole point of the trial. I just wanted to contribute, so even if I\u2019ve had the placebo, I\u2019ve contributed to this important research.\u201d<\/p>\n<p>All study participants will be monitored for 112 weeks after vaccination.<\/p>\n<p>At MFT the trial is being delivered in collaboration with the <a href=\"https:\/\/local.nihr.ac.uk\/lcrn\/greater-manchester\/\">NIHR Clinical Research Network Greater Manchester (CRN GM).<\/a><\/p>\n<p>Dr Tim Felton, an Honorary Consultant at MFT\u2019s Wythenshawe Hospital, is the Trust\u2019s Clinical Lead for all COVID-19 research, as well as the Principal Investigator at MFT for the Janssen Phase 3 study.<\/p>\n<p>Dr Felton, who is also a Senior Lecturer at <a href=\"https:\/\/www.manchester.ac.uk\/\">The University of Manchester<\/a> and a researcher within <a href=\"https:\/\/www.manchesterbrc.nihr.ac.uk\/\">NIHR Manchester Biomedical Research Centre (BRC)<\/a> Respiratory Theme, said: \u201cThroughout all the research we have undertaken into COVID-19 at MFT, finding a safe and effective vaccine has been the top priority.<\/p>\n<p>\u201cRecruiting our final participant into this study is a major step forward in our fight against coronavirus \u2013 and I\u2019d like to thank every person who has volunteered to take part in this vital research.<\/p>\n<p>\u201cIt is critical that we explore a range of vaccination options to give us the greatest chance of protecting as many people as possible, as we continue to the global effort to tackle the COVID-19 pandemic.\u201d<\/p>\n<h3><strong>More about the Janssen (Ad26.COV2.S) vaccine<\/strong><\/h3>\n<p>Like other vaccines, Ad26.COV2.S is expected to prepare the body to defend itself against infection. It contains genetic instructions for what is known as \u2018the spike protein\u2019, which is present on the surface of the coronavirus.<\/p>\n<p>When a person is given the vaccine, their cells will read the genetic instructions and produce the spike protein. The person\u2019s immune system will then treat this protein as foreign and produce natural defences \u2013 antibodies and T-cells \u2013 against it.<\/p>\n<p>If the vaccinated person later comes into contact with COVID-19, their immune system will recognise the virus, with antibodies and immune cells working together to kill it and prevent its entry into the body\u2019s cells.<\/p>\n<ul>\n<li>The UK public can support the national effort to speed up vaccine research and receive more information about volunteering for clinical studies by visiting: <a href=\"https:\/\/www.nhs.uk\/conditions\/coronavirus-covid-19\/research\/coronavirus-vaccine-research\/\">uk\/conditions\/coronavirus-covid-19\/research\/coronavirus-vaccine-research\/<\/a><\/li>\n<li>The ENSEMBLE 2 Janssen study is trialling a <strong>two-dose<\/strong> Janssen COVID-19 vaccine regimen. The results of a separate study, ENSEMLBE, which trialled a <strong>single-dose<\/strong> Janssen COVID-19 vaccine candidate, <a href=\"https:\/\/urldefense.proofpoint.com\/v2\/url?u=https-3A__www.janssen.com_johnson-2Djohnson-2Dannounces-2Dsingle-2Dshot-2Djanssen-2Dcovid-2D19-2Dvaccine-2Dcandidate-2Dmet-2Dprimary-2Dendpoints&amp;d=DwMFaQ&amp;c=bMxC-A1upgdsx4J2OmDkk2Eep4PyO1BA6pjHrrW-ii0&amp;r=5_fNOyLabDiPwXIxYmLfFRzHCwSg3Wv3oFYPlShA0uw&amp;m=K1KivvERtZcqRgE_v14-jAgrMfrZmwrwDdyYKQf6Q64&amp;s=Mpo1NZfndqqBfeQytRvZTsfRfqZVDZcXwiFuzLBH-XE&amp;e=\">were recently published<\/a>.<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Manchester University NHS Foundation Trust (MFT), England\u2019s largest NHS trust, has recruited its final participant to a leading COVID-19 vaccine trial. The Phase 3 study is testing the safety and effectiveness of a new two-dose vaccine regimen, versus a placebo, in preventing moderate to severe\/critical coronavirus disease. The vaccine candidate has been developed by The [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":2407,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[10],"tags":[103,142,143,144],"class_list":["post-2401","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-covid","tag-reaserch","tag-trial","tag-vaccine"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>MFT recruits final participant to Phase 3 COVID-19 vaccine study - Wythenshawe Hospital<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/mft.nhs.uk\/wythenshawe\/mft-recruits-final-participant-to-phase-3-covid-19-vaccine-study\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MFT recruits final participant to Phase 3 COVID-19 vaccine study - Wythenshawe Hospital\" \/>\n<meta property=\"og:description\" content=\"Manchester University NHS Foundation Trust (MFT), England\u2019s largest NHS trust, has recruited its final participant to a leading COVID-19 vaccine trial. The Phase 3 study is testing the safety and effectiveness of a new two-dose vaccine regimen, versus a placebo, in preventing moderate to severe\/critical coronavirus disease. 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