Hill, Philip C;
Cobelens, Frank;
Martinez, Leonardo;
Behr, Marcel A;
Churchyard, Gavin;
Evans, Tom;
Fiore-Gartland, Andrew J;
... White, Richard G; + view all
(2023)
An aspiration to radically shorten phase 3 TB vaccine trials.
The Journal of Infectious Diseases
10.1093/infdis/jiad356.
(In press).
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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.
| Type: | Article |
|---|---|
| Title: | An aspiration to radically shorten phase 3 TB vaccine trials |
| Location: | United States |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1093/infdis/jiad356 |
| Publisher version: | https://doi.org/10.1093/infdis/jiad356 |
| Language: | English |
| Additional information: | This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions. |
| Keywords: | Trial, tuberculosis, vaccine |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute for Global Health |
| URI: | https://discovery-pp.ucl.ac.uk/id/eprint/10176458 |
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