{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T22:39:19Z","timestamp":1788993559133,"version":"build-2803163510"},"reference-count":28,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2021,10,20]],"date-time":"2021-10-20T00:00:00Z","timestamp":1634688000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000272","name":"National Institute for Health Research","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100000272","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100010417","name":"University Hospital Southampton NHS Foundation Trust","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100010417","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2022,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>The safety of novel therapeutics and vaccines are typically assessed in early phase clinical trials involving \u201chealthy volunteers.\u201d Abnormalities in such individuals can be difficult to interpret and may indicate previously unrecognized medical conditions. The frequency of incidental findings (IFs) in healthy volunteers who attend for clinical trial screening is unclear. To assess this, we retrospectively analyzed data for 1838 \u201chealthy volunteers\u201d screened for enrolment in a UK multicenter, phase I\/II severe acute respiratory syndrome\u2010coronavirus 2 (SARS\u2010COV\u20102) vaccine trial. Participants were predominantly White (89.7%, 1640\/1828) with a median age of 34\u00a0years (interquartile range [IQR] = 27\u201344). There were 27.7% of participants (510\/1838) who had at least one IF detected. The likelihood of identifying evidence of a potential, new blood\u2010borne virus infection was low (1 in 238 participants) compared with identification of an elevated alanine transaminase (ALT; 1 in 17 participants). A large proportion of participants described social habits that could impact negatively on their health; 21% consumed alcohol in excess, 10% were current smokers, 11% described recreational drug use, and only 48% had body weight in the ideal range. Our data demonstrate that screening prior to enrollment in early phase clinical trials identifies a range of IFs, which should inform discussion during the consent process. Greater clarity is needed to ensure an appropriate balance is struck between early identification of medical problems and avoidance of exclusion of volunteers due to spurious or physiological abnormalities. Debate should inform the role of the trial physician in highlighting and advising about unhealthy social habits.<\/jats:p>","DOI":"10.1111\/cts.13170","type":"journal-article","created":{"date-parts":[[2021,10,21]],"date-time":"2021-10-21T13:37:27Z","timestamp":1634823447000},"page":"524-534","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Incidental findings in UK healthy volunteers screened for a COVID\u201019 vaccine trial"],"prefix":"10.1111","volume":"15","author":[{"given":"Susanne H.","family":"Hodgson","sequence":"first","affiliation":[{"name":"Centre for Clinical Vaccinology and Tropical Medicine The Jenner Institute University of Oxford  Oxford UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Poppy","family":"Iveson","sequence":"additional","affiliation":[{"name":"The University of Oxford Clinical Medical School University of Oxford  Oxford UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica","family":"Larwood","sequence":"additional","affiliation":[{"name":"The University of Oxford Clinical Medical School University of Oxford  Oxford UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sophie","family":"Roche","sequence":"additional","affiliation":[{"name":"The University of Oxford Clinical Medical School University of Oxford  Oxford UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hazel","family":"Morrison","sequence":"additional","affiliation":[{"name":"Centre for Clinical Vaccinology and Tropical Medicine The Jenner Institute University of Oxford  Oxford UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Cosgrove","sequence":"additional","affiliation":[{"name":"Vaccine Institute St George\u2019s University of London  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eva","family":"Galiza","sequence":"additional","affiliation":[{"name":"Vaccine Institute St George\u2019s University of London  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabina","family":"Ikram","sequence":"additional","affiliation":[{"name":"Vaccine Institute St George\u2019s University of London  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nana\u2010Marie","family":"Lemm","sequence":"additional","affiliation":[{"name":"Clinical Research Facility Imperial College London  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Savviz","family":"Mehdipour","sequence":"additional","affiliation":[{"name":"Clinical Research Facility Imperial College London  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Owens","sequence":"additional","affiliation":[{"name":"NIHR Southampton Clinical Research Facility and NIHR Southampton Biomedical Research Centre University Hospital Southampton NHS Foundation Trust Faculty of Medicine and Institute for Life Sciences University of Southampton  Southampton UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mihaela","family":"Pacurar","sequence":"additional","affiliation":[{"name":"NIHR Southampton Clinical Research Facility and NIHR Southampton Biomedical Research Centre University Hospital Southampton NHS Foundation Trust Faculty of Medicine and Institute for Life Sciences University of Southampton  Southampton UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Schumacher","sequence":"additional","affiliation":[{"name":"Clinical Research Facility Imperial College London  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert H.","family":"Shaw","sequence":"additional","affiliation":[{"name":"Oxford Vaccine Group Department of Paediatrics Centre for Clinical Vaccinology and Tropical Medicine NIHR Oxford Biomedical Research Centre University of Oxford  Oxford UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Saul N.","family":"Faust","sequence":"additional","affiliation":[{"name":"NIHR Southampton Clinical Research Facility and NIHR Southampton Biomedical Research Centre University Hospital Southampton NHS Foundation Trust Faculty of Medicine and Institute for Life Sciences University of Southampton  Southampton UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul T.","family":"Heath","sequence":"additional","affiliation":[{"name":"Vaccine Institute St George\u2019s University of London  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew J.","family":"Pollard","sequence":"additional","affiliation":[{"name":"Oxford Vaccine Group Department of Paediatrics Centre for Clinical Vaccinology and Tropical Medicine NIHR Oxford Biomedical Research Centre University of Oxford  Oxford UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katherine R. 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