An aspiration to radically shorten phase 3 TB vaccine trials. Hill, P. C, Cobelens, F., Martinez, L., Behr, M. A, Churchyard, G., Evans, T., Fiore-Gartland, A. J, Garcia-Basteiro, A. L, Hanekom, W., Rangaka, M. X, Vekemans, J., & White, R. G The Journal of Infectious Diseases, aug, 2023.
An aspiration to radically shorten phase 3 TB vaccine trials [link]Paper  doi  abstract   bibtex   
A new tuberculosis (TB) vaccine is a high priority. However, the classical development pathway is a major deterrent. Most TB cases arise within two years after M. tuberculosis exposure, suggesting a three-year trial period should be possible if sample size is large to maximise the number of early exposures. Increased sample size could be facilitated by working alongside optimised 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 TB vaccine trials.
@article{Hill2023,
abstract = {A new tuberculosis (TB) vaccine is a high priority. However, the classical development pathway is a major deterrent. Most TB cases arise within two years after M. tuberculosis exposure, suggesting a three-year trial period should be possible if sample size is large to maximise the number of early exposures. Increased sample size could be facilitated by working alongside optimised 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 TB vaccine trials.},
author = {Hill, Philip C and Cobelens, Frank and Martinez, Leonardo and Behr, Marcel A and Churchyard, Gavin and Evans, Tom and Fiore-Gartland, Andrew J and Garcia-Basteiro, Alberto L and Hanekom, Willem and Rangaka, Molebogeng X and Vekemans, Johan and White, Richard G},
doi = {10.1093/INFDIS/JIAD356},
file = {:C$\backslash$:/Users/01462563/AppData/Local/Mendeley Ltd./Mendeley Desktop/Downloaded/Hill et al. - 2023 - An aspiration to radically shorten phase 3 TB vaccine trials.pdf:pdf},
issn = {0022-1899},
journal = {The Journal of Infectious Diseases},
keywords = {OA,fund{\_}not{\_}ack,perspective},
mendeley-tags = {OA,fund{\_}not{\_}ack,perspective},
month = {aug},
pages = {jiad356},
pmid = {37607272},
title = {{An aspiration to radically shorten phase 3 TB vaccine trials}},
url = {https://dx.doi.org/10.1093/infdis/jiad356},
year = {2023}
}

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