An Aspiration to Radically Shorten Phase 3 Tuberculosis Vaccine Trials

Philip C. Hill; Frank Cobelens; Leonardo Martinez; Marcel A. Behr; Gavin Churchyard; Tom Evans; Andrew J. Fiore-Gartland; Alberto L. Garcia-Basteiro; Willem Hanekom; Molebogeng X. Rangaka; Johan Vekemans; Richard G. White

doi:https://doi.org/10.1093/infdis/jiad356

An Aspiration to Radically Shorten Phase 3 Tuberculosis Vaccine Trials

Philip C. Hill, Frank Cobelens, Leonardo Martinez, Marcel A. Behr, Gavin Churchyard, Tom Evans, Andrew J. Fiore-Gartland, Alberto L. Garcia-Basteiro, Willem Hanekom, Molebogeng X. Rangaka, Johan Vekemans, Richard G. White

Research output: Contribution to journal › Review article › Academic › peer-review

3 Citations (Scopus)

Abstract

A new tuberculosis vaccine is a high priority. However, the classical development pathway is a major deterrent. Most tuberculosis cases arise within 2 years after Mycobacterium tuberculosis exposure, suggesting a 3-year trial period should be possible if sample size is large to maximize the number of early exposures. Increased sample size could be facilitated by working alongside optimized routine services for case ascertainment, with strategies for enhanced case detection and safety monitoring. Shortening enrolment could be achieved by simplifying screening criteria and procedures and strengthening site capacity. Together, these measures could enable radically shortened phase 3 tuberculosis vaccine trials.

Original language	English
Pages (from-to)	1150-1153
Number of pages	4
Journal	The Journal of Infectious Diseases
Volume	228
Issue number	9
DOIs	https://doi.org/10.1093/infdis/jiad356
Publication status	Published - 1 Nov 2023

Keywords

mycobacterium tuberculosis
phase 3
trial
tuberculosis
vaccine

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title = "An Aspiration to Radically Shorten Phase 3 Tuberculosis Vaccine Trials",

abstract = "A new tuberculosis vaccine is a high priority. However, the classical development pathway is a major deterrent. Most tuberculosis cases arise within 2 years after Mycobacterium tuberculosis exposure, suggesting a 3-year trial period should be possible if sample size is large to maximize the number of early exposures. Increased sample size could be facilitated by working alongside optimized routine services for case ascertainment, with strategies for enhanced case detection and safety monitoring. Shortening enrolment could be achieved by simplifying screening criteria and procedures and strengthening site capacity. Together, these measures could enable radically shortened phase 3 tuberculosis vaccine trials.",

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AU - Hill, Philip C.

AU - Cobelens, Frank

AU - Martinez, Leonardo

AU - Behr, Marcel A.

AU - Churchyard, Gavin

AU - Evans, Tom

AU - Fiore-Gartland, Andrew J.

AU - Garcia-Basteiro, Alberto L.

AU - Hanekom, Willem

AU - Rangaka, Molebogeng X.

AU - Vekemans, Johan

AU - White, Richard G.

N1 - Funding Information: Financial support. No financial support was received for this work. Publisher Copyright: © The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved.

PY - 2023/11/1

Y1 - 2023/11/1

N2 - A new tuberculosis vaccine is a high priority. However, the classical development pathway is a major deterrent. Most tuberculosis cases arise within 2 years after Mycobacterium tuberculosis exposure, suggesting a 3-year trial period should be possible if sample size is large to maximize the number of early exposures. Increased sample size could be facilitated by working alongside optimized routine services for case ascertainment, with strategies for enhanced case detection and safety monitoring. Shortening enrolment could be achieved by simplifying screening criteria and procedures and strengthening site capacity. Together, these measures could enable radically shortened phase 3 tuberculosis vaccine trials.

AB - A new tuberculosis vaccine is a high priority. However, the classical development pathway is a major deterrent. Most tuberculosis cases arise within 2 years after Mycobacterium tuberculosis exposure, suggesting a 3-year trial period should be possible if sample size is large to maximize the number of early exposures. Increased sample size could be facilitated by working alongside optimized routine services for case ascertainment, with strategies for enhanced case detection and safety monitoring. Shortening enrolment could be achieved by simplifying screening criteria and procedures and strengthening site capacity. Together, these measures could enable radically shortened phase 3 tuberculosis vaccine trials.

KW - mycobacterium tuberculosis

KW - phase 3

KW - trial

KW - tuberculosis

KW - vaccine

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JO - The Journal of Infectious Diseases

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ER -

An Aspiration to Radically Shorten Phase 3 Tuberculosis Vaccine Trials

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Keywords

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