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Incidental findings in UK healthy volunteers screened for a COVID-19 vaccine trial

Incidental findings in UK healthy volunteers screened for a COVID-19 vaccine trial
Incidental findings in UK healthy volunteers screened for a COVID-19 vaccine trial

The safety of novel therapeutics and vaccines are typically assessed in early phase clinical trials involving "healthy volunteers." 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 "healthy volunteers" screened for enrolment in a UK multicenter, phase I/II severe acute respiratory syndrome-coronavirus 2 (SARS-COV-2) vaccine trial. Participants were predominantly White (89.7%, 1640/1828) with a median age of 34 years (interquartile range [IQR] = 27-44). 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-borne 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.

1752-8054
Hodgson, Susanne H
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Iveson, Poppy
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Larwood, Jessica
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Roche, Sophie
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Morrison, Hazel
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Cosgrove, Catherine
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Galiza, Eva
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Ikram, Sabina
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Lemm, Nana-Marie
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Mehdipour, Savviz
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Owens, Daniel
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Pacurar, Mihaela
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Schumacher, Michael
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Shaw, Robert H
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Faust, Saul N
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Heath, Paul T
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Pollard, Andrew J
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Emary, Katherine R W
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Pollock, Katarina M
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Lazarus, Rajeka
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Hodgson, Susanne H
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Iveson, Poppy
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Larwood, Jessica
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Roche, Sophie
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Morrison, Hazel
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Cosgrove, Catherine
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Galiza, Eva
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Ikram, Sabina
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Lemm, Nana-Marie
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Mehdipour, Savviz
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Owens, Daniel
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Pacurar, Mihaela
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Schumacher, Michael
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Shaw, Robert H
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Faust, Saul N
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Heath, Paul T
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Pollard, Andrew J
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Emary, Katherine R W
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Pollock, Katarina M
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Lazarus, Rajeka
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Hodgson, Susanne H, Iveson, Poppy, Larwood, Jessica, Roche, Sophie, Morrison, Hazel, Cosgrove, Catherine, Galiza, Eva, Ikram, Sabina, Lemm, Nana-Marie, Mehdipour, Savviz, Owens, Daniel, Pacurar, Mihaela, Schumacher, Michael, Shaw, Robert H, Faust, Saul N, Heath, Paul T, Pollard, Andrew J, Emary, Katherine R W, Pollock, Katarina M and Lazarus, Rajeka (2021) Incidental findings in UK healthy volunteers screened for a COVID-19 vaccine trial. Clinical and translational science. (doi:10.1111/cts.13170).

Record type: Article

Abstract

The safety of novel therapeutics and vaccines are typically assessed in early phase clinical trials involving "healthy volunteers." 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 "healthy volunteers" screened for enrolment in a UK multicenter, phase I/II severe acute respiratory syndrome-coronavirus 2 (SARS-COV-2) vaccine trial. Participants were predominantly White (89.7%, 1640/1828) with a median age of 34 years (interquartile range [IQR] = 27-44). 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-borne 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.

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Clinical Translational Sci - 2021 - Hodgson - Incidental findings in UK healthy volunteers screened for a COVID‐19 vaccine - Version of Record
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Accepted/In Press date: 13 September 2021
e-pub ahead of print date: 20 October 2021

Identifiers

Local EPrints ID: 453491
URI: http://eprints.soton.ac.uk/id/eprint/453491
ISSN: 1752-8054
PURE UUID: 935f77b8-0768-4c6b-b9be-ebff852d283d
ORCID for Saul N Faust: ORCID iD orcid.org/0000-0003-3410-7642

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Date deposited: 18 Jan 2022 17:40
Last modified: 17 Mar 2024 03:06

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Contributors

Author: Susanne H Hodgson
Author: Poppy Iveson
Author: Jessica Larwood
Author: Sophie Roche
Author: Hazel Morrison
Author: Catherine Cosgrove
Author: Eva Galiza
Author: Sabina Ikram
Author: Nana-Marie Lemm
Author: Savviz Mehdipour
Author: Daniel Owens
Author: Mihaela Pacurar
Author: Michael Schumacher
Author: Robert H Shaw
Author: Saul N Faust ORCID iD
Author: Paul T Heath
Author: Andrew J Pollard
Author: Katherine R W Emary
Author: Katarina M Pollock
Author: Rajeka Lazarus

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