Evidence map›Paper›PMID 40618773›Full record

ReviewThe Lancet. Respiratory medicine2025

Evidence required to evaluate the use of bacteriologically confirmed asymptomatic tuberculosis disease as a primary endpoint in prevention of tuberculosis disease vaccine licensure trials.

Richard G White, Gavin J Churchyard, Katherine C Horton, Andrew Fiore-Gartland, Marcel A Behr, Rebecca A Clark, Frank Cobelens, Joel D Ernst, Hanif Esmail, Alberto L Garcia-Basteiro and 13 more

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in The Lancet. Respiratory medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

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

1 citing paper in PubMed.

  1. 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

23 authors.

Richard G WhiteDepartment of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK; TB Centre, London School of Hygiene and Tropical Medicine, London, UK. Electronic address: richard.white@lshtm.ac.uk.
Gavin J ChurchyardThe Aurum Institute, Johannesburg, South Africa; Department of Medicine, Vanderbilt University, Nashville, TN, USA; School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Katherine C HortonDepartment of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK; TB Centre, London School of Hygiene and Tropical Medicine, London, UK.
Andrew Fiore-GartlandVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Marcel A BehrMcGill International TB Centre, McGill University, Montreal, QC, Canada.
Rebecca A ClarkDepartment of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK; TB Centre, London School of Hygiene and Tropical Medicine, London, UK.
Frank CobelensDepartment of Global Health, Amsterdam University Medical Centres, University of Amsterdam, Amsterdam, Netherlands; Amsterdam Institute of Global Health and Development, Amsterdam, Netherlands.
Joel D ErnstDepartment of Medicine, Division of Experimental Medicine, University of California San Francisco, San Francisco, CA, USA.
Hanif EsmailMedical Research Council Clinical Trials Unit, University College London, London, UK; WHO Collaborating Centre for TB Research and Innovation, Institute for Global Health, University College London, London, UK; Centre for Infectious Diseases Research Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Alberto L Garcia-BasteiroISGlobal, Hospital Clínic - Universitat de Barcelona, Barcelona, Spain; Centro de Investigação em Saúde de Manhiça, Maputo, Mozambique; Centro de Investigación Biomédica en Red de Enfermedades Infecciosas, Barcelona, Spain.
Sri Rezeki HadinegoroDepartment of Child Health, Faculty of Medicine Universitas Indonesia, Jakarta, Indonesia.
Willem A HanekomDivision of Infection and Immunity, University College London, London, UK; Africa Health Research Institute, Durban, South Africa.
Mark HatherillSouth African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa; Department of Pathology, University of Cape Town, Cape Town, South Africa.
Philip C HillCentre for International Health, University of Otago, Dunedin, New Zealand.
Rudzani MuloiwaDepartment of Paediatrics and Child Health, University of Cape Town, Cape Town, South Africa.
Puck T PelzerInternational AIDS Vaccine Initiative, New York, NY, USA.
Lele RangakaMedical Research Council Clinical Trials Unit, University College London, London, UK; WHO Collaborating Centre for TB Research and Innovation, Institute for Global Health, University College London, London, UK; Centre for Infectious Diseases Research Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Helen ReesWits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa.
Lewis SchragerInternational AIDS Vaccine Initiative, New York, NY, USA.
Margaret StanleyDepartment of Pathology, University of Cambridge, Cambridge, UK.
Marta TufetGAVI, the Vaccine Alliance, Geneva, Switzerland.
Emily B WongAfrica Health Research Institute, Durban, South Africa; Division of Infectious Diseases, Heersink School of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.
Rein M G J HoubenDepartment of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK; TB Centre, London School of Hygiene and Tropical Medicine, London, UK.

Funding

IMMUNE MECHANISMS OF PROTECTION AGAINST MYCOBACTERIUM TUBERCULOSIS CENTER (IMPAC-TB) - SARS-CoV-2 RELATED RESEARCH75N93019C00070 · NIAID · SEATTLE CHILDREN'S HOSPITAL · PI URDAHL, KEVIN · 2019 to 2025
$86.6M
Aurum Clinical Trials UnitUM1AI154463 · NIAID · AURUM INSTITUTE NPC · PI Gavin John Churchyard · 2021 to 2026
$8.1M
Seattle Tuberculosis Research Advancement CenterP30AI168034 · NIAID · UNIVERSITY OF WASHINGTON · PI Rhea N Coler, CHETAN SESHADRI · 2022 to 2026
$6.3M
Defining drivers of TB transmission in the era of universal ART, and implications for finding the walking wellR01AI147321 · NIAID · LONDON SCH/HYGIENE & TROPICAL MEDICINE · PI GRANT, ALISON · 2019 to 2024
$2.3M
Imaging signatures of early tuberculosisR01AI175555 · NIAID · RUTGERS BIOMEDICAL AND HEALTH SCIENCES · PI Yingda Linda Xie · 2024 to 2026
$2.0M
Bill & Melinda Gates Foundation INV-001754Bill & Melinda Gates Foundation INV-035506NIAID NIH HHS 75N93019C00070NIAID NIH HHS P30 AI168034NIAID NIH HHS R01 AI147321NIAID NIH HHS R01 AI175555NIAID NIH HHS UM1 AI154463Wellcome Trust
6 · The paper itself

Abstract

Current licensure trials of new vaccines to prevent tuberculosis disease use bacteriologically confirmed symptomatic tuberculosis disease as the primary endpoint. Globally, the incidence of symptomatic tuberculosis disease is low, making licensure trials large, long, and expensive. New data suggest that bacteriologically confirmed asymptomatic tuberculosis disease might occur more frequently than symptomatic tuberculosis disease. Therefore, if vaccines have efficacy against asymptomatic disease, tuberculosis vaccine licensure trials could include it in the primary endpoint, potentially leading to smaller or shorter trials. We describe the potential benefits and risks of this inclusion in the primary endpoint of tuberculosis vaccine licensure trials. We also simulate licensure trial endpoint accrual and summarise feedback from anonymous regulators and policy makers on the knowledge needed to consider this proposal and research studies needed to fill these evidence gaps. If bacteriologically confirmed asymptomatic tuberculosis disease could be included in the primary endpoint of tuberculosis disease licensure trials, it could lead to cheaper and more rapid tuberculosis vaccine development.

Indexed as

Asymptomatic InfectionsEndpoint DeterminationTuberculosisTuberculosis VaccinesClinical Trials as TopicHumansMycobacterium tuberculosisTuberculosis Vaccines

Identifiers

PMID40618773
PMCPMC12742221

What OpenQuestion holds

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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.