del Pozo-Ramos, Lidia, and Kupz, Andreas (2025) A review of the efficacy of clinical tuberculosis vaccine candidates in mouse models. Frontiers in Immunology, 16. 1609136.

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Abstract

Tuberculosis (TB) remains one of the deadliest infectious diseases worldwide, causing over a million deaths annually. The only licensed TB vaccine for human use, Bacille Calmette-Guérin (BCG), a mycobacteria-based live-attenuated vaccine, confers immunity to children but fails to efficiently protect adults from pulmonary TB. Several TB vaccine candidates have been developed over the last two decades, but some have failed to provide substantially better protection than BCG in clinical trials. Most of these vaccine candidates were initially evaluated for their protective capacity in mouse models of TB. With the availability of several mouse strains, vaccination routes and Mycobacterium tuberculosis (Mtb) challenge strains, to-date there is no consensus in the field about the predictive value of different murine models of TB, and it remains a matter of debate whether host genetics or vaccine-driven parameters primarily determine vaccine efficacy. Here we reviewed the performance of all TB vaccine candidates that have entered clinical trials over the last 25 years. We extracted protective efficacy data from all published studies that utilized mouse models to assess vaccination efficacy. The efficacy of each vaccine candidate to reduce lung bacterial burden depending on the mouse genotype, the vaccine administration route, and the Mtb challenge strain at different time-points was evaluated. Our data reveals insights into the effect of experimental parameters on vaccine performance and emphasizes the potential benefits of standardizing TB mouse models across vaccination-challenge studies to identify pre-clinical vaccine candidates with the highest potential to succeed.

Item ID:	86519
Item Type:	Article (Research - C1)
ISSN:	1664-3224
Copyright Information:	Copyright © 2025 del Pozo-Ramos and Kupz. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
Funders:	National Health and Medical Research Council (NHMRC)
Projects and Grants:	NHMRC Investigator Grant (APP2008715)
Date Deposited:	05 Aug 2025 04:13
FoR Codes:	32 BIOMEDICAL AND CLINICAL SCIENCES > 3207 Medical microbiology > 320702 Medical infection agents (incl. prions) @ 30% 31 BIOLOGICAL SCIENCES > 3107 Microbiology > 310701 Bacteriology @ 30% 32 BIOMEDICAL AND CLINICAL SCIENCES > 3204 Immunology > 320499 Immunology not elsewhere classified @ 40%
SEO Codes:	28 EXPANDING KNOWLEDGE > 2801 Expanding knowledge > 280103 Expanding knowledge in the biomedical and clinical sciences @ 100%
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