Evidence map›Paper›PMID 39611145›Full record

ArticleFrontiers in immunology2024

A dose escalation study to evaluate the safety of an aerosol BCG infection in previously BCG-vaccinated healthy human UK adults.

Timothy Fredsgaard-Jones, Stephanie A Harris, Hazel Morrison, Alberta Ateere, Beatrice Nassanga, Raquel Lopez Ramon, Celia Mitton, Eve Fletcher, Jonathan Decker, Hannah Preston-Jones and 7 more

Registry-linked trialAbstract readClinical Trial, Phase I
In one paragraph

Article in Frontiers in immunology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04777721 (A Clinical Challenge Study to Evaluate Controlled Human Infection With BCG Administered by the Aerosol Inhaled Route in Historically BCG-vaccinated Healthy Adult Volunteers), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
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.

NCT04777721 phase1completednot on this map

A Clinical Challenge Study to Evaluate Controlled Human Infection With BCG Administered by the Aerosol Inhaled Route in Historically BCG-vaccinated Healthy Adult Volunteers

TypeinterventionalSponsorUniversity of OxfordRan2022 to 2023Enrolled12ConditionsTuberculosisArmsBCG Danish
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Review
  5. 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

17 authors.

Timothy Fredsgaard-JonesThe Jenner Institute, University of Oxford, Oxford, United Kingdom.
Stephanie A HarrisThe Jenner Institute, University of Oxford, Oxford, United Kingdom.
Hazel MorrisonThe Jenner Institute, University of Oxford, Oxford, United Kingdom.
Alberta AteereThe Jenner Institute, University of Oxford, Oxford, United Kingdom.
Beatrice NassangaThe Jenner Institute, University of Oxford, Oxford, United Kingdom.
Raquel Lopez RamonThe Jenner Institute, University of Oxford, Oxford, United Kingdom.
Celia MittonThe Jenner Institute, University of Oxford, Oxford, United Kingdom.
Eve FletcherDepartment of Respiratory Science, University of Leicester, Leicester, United Kingdom.
Jonathan DeckerDepartment of Respiratory Science, University of Leicester, Leicester, United Kingdom.
Hannah Preston-JonesThe Jenner Institute, University of Oxford, Oxford, United Kingdom.
Susan JacksonThe Jenner Institute, University of Oxford, Oxford, United Kingdom.
Andrew MawerThe Jenner Institute, University of Oxford, Oxford, United Kingdom.
Iman SattiThe Jenner Institute, University of Oxford, Oxford, United Kingdom.
Michael BarerDepartment of Respiratory Science, University of Leicester, Leicester, United Kingdom.
Timothy HinksOxford Centre for Respiratory Medicine, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.
Henry BettinsonOxford Centre for Respiratory Medicine, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.
Helen McShaneThe Jenner Institute, University of Oxford, Oxford, United Kingdom.

Funding

IMMUNE MECHANISMS OF PROTECTION AGAINST MYCOBACTERIUM TUBERCULOSIS CENTER (IMPAC-TB)75N93021C00029 · NIAID · SEATTLE CHILDREN'S HOSPITAL · PI COLER, RHEA · 2022 to 2025
$35.2M
NIH HHS 75N93021C00029
6 · The paper itself

Abstract

Introduction: Tuberculosis (TB) is the leading cause of death worldwide from a single infectious agent. Bacillus Calmette-Guérin (BCG), the only licensed vaccine, provides limited protection. Controlled human infection models (CHIMs) are useful in accelerating vaccine development for pathogens with no correlates of protection; however, the need for prolonged treatment makes Methods: There were 12 healthy, historically BCG-vaccinated UK adults sequentially enrolled into dose-escalating groups. The first three received 1 × 10 Results: No serious AEs occurred during the study. Solicited systemic and respiratory AEs were frequent in all groups, but generally short-lived and mild in severity. There was a trend for more reported AEs in the highest-dose group. No live BCG was detected in BAL from any volunteers. Aerosol BCG induced potent systemic cellular immune responses in the highest-dose group 7 days post-infection. Discussion: Aerosol BCG infection up to a dose of 1 × 10 Clinical trial registration: https://clinicaltrials.gov/, identifier NCT04777721.

Indexed as

AerosolsBCG VaccineAdultFemaleHealthy VolunteersHumansMaleMiddle AgedMycobacterium tuberculosisTuberculosisUnited KingdomVaccinationYoung AdultAerosolsBCG VaccineaerosolBCGCHIMtuberculosisvaccine

Identifiers

PMID39611145
PMCPMC11602284

What OpenQuestion holds

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Registered trials

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.