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...

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Bibliographic Details
Published in:The Journal of infectious diseases 2023-11, Vol.228 (9), p.1150-1153
Main Authors: Hill, Philip C, Cobelens, Frank, Martinez, Leonardo, Behr, Marcel A, Churchyard, Gavin, Evans, Tom, Fiore-Gartland, Andrew J, Garcia-Basteiro, Alberto L, Hanekom, Willem, Rangaka, Molebogeng X, Vekemans, Johan, White, Richard G
Format: Article
Language:English
Subjects:
Double-Blind Method
Humans
Mycobacterium tuberculosis - immunology
Nuts - immunology
Tuberculosis
Tuberculosis - immunology
Tuberculosis - prevention & control
Tuberculosis Vaccines - immunology
Vaccines
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Summary: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. A new tuberculosis vaccine is urgent but licensure requires clinical trials that take many years. Options for an accelerated phase 3 tuberculosis vaccine prevention of disease trial through increasing trial sample size and shortening the enrolment period are discussed.
ISSN:0022-1899
1537-6613
1537-6613
DOI:10.1093/infdis/jiad356