Academic Journal

Bridging the translational gap: an operational classification and quantitative framework for accelerating enteric vaccine research using animal models.

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Title: Bridging the translational gap: an operational classification and quantitative framework for accelerating enteric vaccine research using animal models.
Authors: Koley H; Division of Bacteriology, ICMR-National Institute for Research in Bacterial Infections, P-33 CIT Road, Scheme -XM, Beliaghata, Kolkata 700010, India. Electronic address: hemantakoley@hotmail.com., Mukherjee A; Division of Bacteriology, ICMR-National Institute for Research in Bacterial Infections, P-33 CIT Road, Scheme -XM, Beliaghata, Kolkata 700010, India., Mukhopadhyay AK; Division of Bacteriology, ICMR-National Institute for Research in Bacterial Infections, P-33 CIT Road, Scheme -XM, Beliaghata, Kolkata 700010, India., Das S; Division of Bacteriology, ICMR-National Institute for Research in Bacterial Infections, P-33 CIT Road, Scheme -XM, Beliaghata, Kolkata 700010, India., Howlader DR; Division of Bacteriology, ICMR-National Institute for Research in Bacterial Infections, P-33 CIT Road, Scheme -XM, Beliaghata, Kolkata 700010, India. Electronic address: debaki.r.howlader@gmail.com.
Source: Vaccine [Vaccine] 2026 Oct 24; Vol. 92, pp. 129167. Date of Electronic Publication: 2026 Sep 23.
Publication Type: Journal Article; Review
Language: English
Journal Info: Publisher: Elsevier Science Country of Publication: Netherlands NLM ID: 8406899 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-2518 (Electronic) Linking ISSN: 0264410X NLM ISO Abbreviation: Vaccine Subsets: MEDLINE
Imprint Name(s): Publication: Amsterdam, The Netherlands : Elsevier Science
Original Publication: [Guildford, Surrey, UK] : Butterworths, [c1983-
MeSH Terms: Vaccine Development*/methods , Disease Models, Animal* , Translational Research, Biomedical*, Dysentery, Bacillary/prevention & control ; Salmonella Infections/prevention & control ; Animals ; Humans ; Guinea Pigs ; Mice ; Rabbits ; Zebrafish
Abstract: Enteric bacterial infections, notably shigellosis and salmonellosis, represent a staggering global health burden. Vaccine development is severely hampered by host-restriction, creating a persistent "translational gap" where preclinical data fails to correlate with human outcomes. Traditionally, model selection has been largely qualitative. This review provides a comprehensive analysis of the research landscape, evaluating the physiological fidelity of non-human primates, the surgical precision of rabbit and guinea pig models, and specialized induced rodent systems, including the streptomycin‑iron-overload mouse model. We further discuss emerging alternatives, including translucent zebrafish for real-time imaging and Human Intestinal Enteroids (HIE) for human-specific mechanistic insights. Crucially, we move beyond qualitative descriptions by introducing the Model Utility Index (MUI), a novel quantitative framework designed to objectively balance Normalized Clinical Fidelity (F) against the Geometric Efficiency Quotient (E). By applying constrained optimization logic, we propose the Context-Specific Model Optimization (CSMO) selection matrix to simplify the logistical burden of model choice, focusing on the unique translational hurdles of host-restricted invasive pathogens such as Shigella and typhoidal Salmonella. This strategy aligns specific research bottlenecks - from high-throughput screening to final regulatory validation, with mathematically optimized research systems. In light of the FDA Modernization Act 2.0, this integrated approach provides a robust roadmap for utilizing New Approach Methodologies (NAMs) to de-risk clinical transitions and accelerate the licensure of next-generation enteric vaccines.
(Copyright © 2026 Elsevier Ltd. All rights reserved.)
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
Contributed Indexing: Keywords: Animal models; Bacterial pathogenesis; Disease models; Enteric pathogens; Model utility index (MUI); Vaccine development
Entry Date(s): Date Created: 20260924 Date Completed: 20260927 Latest Revision: 20260927
Update Code: 20260928
DOI: 10.1016/j.vaccine.2026.129167
PMID: 42784864
Database: MEDLINE
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  Data: Bridging the translational gap: an operational classification and quantitative framework for accelerating enteric vaccine research using animal models.
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  Data: <searchLink fieldCode="AU" term="%22Koley+H%22">Koley H</searchLink>; Division of Bacteriology, ICMR-National Institute for Research in Bacterial Infections, P-33 CIT Road, Scheme -XM, Beliaghata, Kolkata 700010, India. Electronic address: hemantakoley@hotmail.com.<br /><searchLink fieldCode="AU" term="%22Mukherjee+A%22">Mukherjee A</searchLink>; Division of Bacteriology, ICMR-National Institute for Research in Bacterial Infections, P-33 CIT Road, Scheme -XM, Beliaghata, Kolkata 700010, India.<br /><searchLink fieldCode="AU" term="%22Mukhopadhyay+AK%22">Mukhopadhyay AK</searchLink>; Division of Bacteriology, ICMR-National Institute for Research in Bacterial Infections, P-33 CIT Road, Scheme -XM, Beliaghata, Kolkata 700010, India.<br /><searchLink fieldCode="AU" term="%22Das+S%22">Das S</searchLink>; Division of Bacteriology, ICMR-National Institute for Research in Bacterial Infections, P-33 CIT Road, Scheme -XM, Beliaghata, Kolkata 700010, India.<br /><searchLink fieldCode="AU" term="%22Howlader+DR%22">Howlader DR</searchLink>; Division of Bacteriology, ICMR-National Institute for Research in Bacterial Infections, P-33 CIT Road, Scheme -XM, Beliaghata, Kolkata 700010, India. Electronic address: debaki.r.howlader@gmail.com.
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  Data: <searchLink fieldCode="JN" term="%228406899%22">Vaccine</searchLink> [Vaccine] 2026 Oct 24; Vol. 92, pp. 129167. <i>Date of Electronic Publication: </i>2026 Sep 23.
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  Data: Enteric bacterial infections, notably shigellosis and salmonellosis, represent a staggering global health burden. Vaccine development is severely hampered by host-restriction, creating a persistent "translational gap" where preclinical data fails to correlate with human outcomes. Traditionally, model selection has been largely qualitative. This review provides a comprehensive analysis of the research landscape, evaluating the physiological fidelity of non-human primates, the surgical precision of rabbit and guinea pig models, and specialized induced rodent systems, including the streptomycin‑iron-overload mouse model. We further discuss emerging alternatives, including translucent zebrafish for real-time imaging and Human Intestinal Enteroids (HIE) for human-specific mechanistic insights. Crucially, we move beyond qualitative descriptions by introducing the Model Utility Index (MUI), a novel quantitative framework designed to objectively balance Normalized Clinical Fidelity (F) against the Geometric Efficiency Quotient (E). By applying constrained optimization logic, we propose the Context-Specific Model Optimization (CSMO) selection matrix to simplify the logistical burden of model choice, focusing on the unique translational hurdles of host-restricted invasive pathogens such as Shigella and typhoidal Salmonella. This strategy aligns specific research bottlenecks - from high-throughput screening to final regulatory validation, with mathematically optimized research systems. In light of the FDA Modernization Act 2.0, this integrated approach provides a robust roadmap for utilizing New Approach Methodologies (NAMs) to de-risk clinical transitions and accelerate the licensure of next-generation enteric vaccines.<br /> (Copyright © 2026 Elsevier Ltd. All rights reserved.)
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  Data: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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  Data: <i>Keywords: </i>Animal models; Bacterial pathogenesis; Disease models; Enteric pathogens; Model utility index (MUI); Vaccine development
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        Value: 10.1016/j.vaccine.2026.129167
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        Text: English
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      – SubjectFull: Salmonella Infections prevention & control
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      – TitleFull: Bridging the translational gap: an operational classification and quantitative framework for accelerating enteric vaccine research using animal models.
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