Evidence map›Paper›PMID 34670021›Full record

Trial reportClinical and translational science2022

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

Susanne H Hodgson, Poppy Iveson, Jessica Larwood, Sophie Roche, Hazel Morrison, Catherine Cosgrove, Eva Galiza, Sabina Ikram, Nana-Marie Lemm, Savviz Mehdipour and 10 more

Open access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical and translational science, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.1field-weighted citation impact, top 50% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 3 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors at 10 institutions in 1 country.

Susanne H HodgsonCentre for Clinical Vaccinology and Tropical Medicine, The Jenner Institute, University of Oxford, Oxford, UK.
Poppy IvesonThe University of Oxford Clinical Medical School, University of Oxford, Oxford, UK.
Jessica LarwoodThe University of Oxford Clinical Medical School, University of Oxford, Oxford, UK.
Sophie RocheThe University of Oxford Clinical Medical School, University of Oxford, Oxford, UK.
Hazel MorrisonCentre for Clinical Vaccinology and Tropical Medicine, The Jenner Institute, University of Oxford, Oxford, UK.
Catherine CosgroveVaccine Institute, St George's University of London, London, UK.
Eva GalizaVaccine Institute, St George's University of London, London, UK.
Sabina IkramVaccine Institute, St George's University of London, London, UK.
Nana-Marie LemmClinical Research Facility, Imperial College London, London, UK.
Savviz MehdipourClinical Research Facility, Imperial College London, London, UK.
Daniel OwensNIHR 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.
Mihaela PacurarNIHR 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.
Michael SchumacherClinical Research Facility, Imperial College London, London, UK.
Robert H ShawOxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, UK.
Saul N FaustNIHR 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.
Paul T HeathVaccine Institute, St George's University of London, London, UK.
Andrew J PollardOxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, UK.
Katherine R W EmaryOxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, UK.
Katrina M PollockClinical Research Facility, Imperial College London, London, UK.
Rajeka LazarusUniversity Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.
St George's, University of London · GBUniversity of Oxford · GBImperial College London · GBJenner Institute · GBOxford BioMedica (United Kingdom) · GBNIHR Imperial Biomedical Research Centre · GBNIHR Southampton Biomedical Research Centre · GBUniversity Hospitals Bristol and Weston NHS Foundation TrustUniversity Hospital Southampton NHS Foundation Trust · GBUniversity of Southampton · GB

Funding

Medical Research Council MC_PC_19055Medical Research Council MR/W024977/1
6 · The paper itself

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.

Indexed as

Incidental FindingsAdultAlanine TransaminaseBody Mass IndexCOVID-19COVID-19 VaccinesFemaleHealthy VolunteersHumansMaleRetrospective StudiesSARS-CoV-2Alanine TransaminaseCOVID-19 Vaccines

Identifiers

PMID34670021
PMCPMC8652599
OpenAlexW3205869052

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.