Review of current tuberculosis human infection studies for use in accelerating tuberculosis vaccine development: a meeting report
File(s)
Published version
Author(s)
Type
Journal Article
Abstract
Tools to evaluate and accelerate tuberculosis (TB) vaccine development are needed to advance global TB control strategies. Validated human infection studies for TB have the potential to facilitate breakthroughs in understanding disease pathogenesis, identify correlates of protection, develop diagnostic tools, and accelerate and de-risk vaccine and drug development. However, key challenges remain for realizing the clinical utility of these models, which require further discussion and alignment among key stakeholders. In March 2023, the Wellcome Trust and the International AIDS Vaccine Initiative convened international experts involved in developing both TB and bacillus Calmette-Guérin (BCG) human infection studies (including mucosal and intradermal challenge routes) to discuss the status of each of the models and the key enablers to move the field forward. This report provides a summary of the presentations and discussion from the meeting. Discussions identified key issues, including demonstrating model validity, to provide confidence for vaccine developers, which may be addressed through demonstration of known vaccine effects (eg, BCG vaccination in specific populations), and by comparing results from field efficacy and human infection studies. The workshop underscored the importance of establishing safe and acceptable studies in high-burden settings, and the need to validate >1 model to allow for different scientific questions to be addressed as well as to provide confidence to vaccine developers and regulators around use of human infection study data in vaccine development and licensure pathways.
Date Issued
2024-08-15
Date Acceptance
2024-05-03
Citation
The Journal of Infectious Diseases, 2024, 230 (2), pp.e457-e464
ISSN
0022-1899
Publisher
Oxford University Press (OUP)
Start Page
e457
End Page
e464
Journal / Book Title
The Journal of Infectious Diseases
Volume
230
Issue
2
Copyright Statement
© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases
Society of America.
This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (https://creativecommons.org/licenses/by-nc-nd/4.0/), which
permits non-commercial reproduction and distribution of the work, in any medium, provided
the original work is not altered or transformed in any way, and that the work is properly cited.
For commercial re-use, please contact reprints@oup.com for reprints and translation rights for
reprints. All other permissions can be obtained through our RightsLink service via the
Permissions link on the article page on our site—for further information please contact
journals.permissions@oup.com.
Society of America.
This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (https://creativecommons.org/licenses/by-nc-nd/4.0/), which
permits non-commercial reproduction and distribution of the work, in any medium, provided
the original work is not altered or transformed in any way, and that the work is properly cited.
For commercial re-use, please contact reprints@oup.com for reprints and translation rights for
reprints. All other permissions can be obtained through our RightsLink service via the
Permissions link on the article page on our site—for further information please contact
journals.permissions@oup.com.
Identifier
http://dx.doi.org/10.1093/infdis/jiae238
Publication Status
Published
Date Publish Online
2024-05-06