Academic Journal
Bridging the translational gap: an operational classification and quantitative framework for accelerating enteric vaccine research using animal models.
| 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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| Items | – Name: Title Label: Title Group: Ti Data: Bridging the translational gap: an operational classification and quantitative framework for accelerating enteric vaccine research using animal models. – Name: Author Label: Authors Group: Au 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. – Name: TitleSource Label: Source Group: Src 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. – Name: TypePub Label: Publication Type Group: TypPub Data: Journal Article; Review – Name: Language Label: Language Group: Lang Data: English – Name: TitleSource Label: Journal Info Group: Src Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Elsevier+Science%22">Elsevier Science </searchLink><i>Country of Publication: </i>Netherlands <i>NLM ID: </i>8406899 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1873-2518 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%220264410X%22">0264410X </searchLink><i>NLM ISO Abbreviation: </i>Vaccine <i>Subsets: </i>MEDLINE – Name: PublisherInfo Label: Imprint Name(s) Group: PubInfo Data: <i>Publication</i>: Amsterdam, The Netherlands : Elsevier Science<br /><i>Original Publication</i>: [Guildford, Surrey, UK] : Butterworths, [c1983- – Name: SubjectMESH Label: MeSH Terms Group: Su Data: <searchLink fieldCode="MM" term="%22Vaccine+Development%22">Vaccine Development*</searchLink>/<searchLink fieldCode="MM" term="%22Vaccine+Development+methods%22">methods</searchLink> <br /><searchLink fieldCode="MM" term="%22Disease+Models%2C+Animal%22">Disease Models, Animal*</searchLink> <br /><searchLink fieldCode="MM" term="%22Translational+Research%2C+Biomedical%22">Translational Research, Biomedical*</searchLink><br /><searchLink fieldCode="MH" term="%22Dysentery%2C+Bacillary%22">Dysentery, Bacillary</searchLink>/<searchLink fieldCode="MH" term="%22Dysentery%2C+Bacillary+prevention+%26+control%22">prevention & control</searchLink> ; <searchLink fieldCode="MH" term="%22Salmonella+Infections%22">Salmonella Infections</searchLink>/<searchLink fieldCode="MH" term="%22Salmonella+Infections+prevention+%26+control%22">prevention & control</searchLink> ; <searchLink fieldCode="MH" term="%22Animals%22">Animals</searchLink> ; <searchLink fieldCode="MH" term="%22Humans%22">Humans</searchLink> ; <searchLink fieldCode="MH" term="%22Guinea+Pigs%22">Guinea Pigs</searchLink> ; <searchLink fieldCode="MH" term="%22Mice%22">Mice</searchLink> ; <searchLink fieldCode="MH" term="%22Rabbits%22">Rabbits</searchLink> ; <searchLink fieldCode="MH" term="%22Zebrafish%22">Zebrafish</searchLink> – Name: Abstract Label: Abstract Group: Ab 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.) – Name: Abstract Label: Competing Interests Group: Ab 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. – Name: SubjectMinor Label: Contributed Indexing Group: Data: <i>Keywords: </i>Animal models; Bacterial pathogenesis; Disease models; Enteric pathogens; Model utility index (MUI); Vaccine development – Name: DateEntry Label: Entry Date(s) Group: Date Data: <i>Date Created: </i>20260924 <i>Date Completed: </i>20260927 <i>Latest Revision: </i>20260927 – Name: DateUpdate Label: Update Code Group: Date Data: 20260928 – Name: DOI Label: DOI Group: ID Data: 10.1016/j.vaccine.2026.129167 – Name: AN Label: PMID Group: ID Data: 42784864 |
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| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1016/j.vaccine.2026.129167 Languages: – Code: eng Text: English PhysicalDescription: Pagination: StartPage: 129167 Subjects: – SubjectFull: Dysentery, Bacillary prevention & control Type: general – SubjectFull: Salmonella Infections prevention & control Type: general – SubjectFull: Animals Type: general – SubjectFull: Humans Type: general – SubjectFull: Guinea Pigs Type: general – SubjectFull: Mice Type: general – SubjectFull: Rabbits Type: general – SubjectFull: Zebrafish Type: general – SubjectFull: Vaccine Development methods Type: general – SubjectFull: Disease Models, Animal Type: general – SubjectFull: Translational Research, Biomedical Type: general Titles: – TitleFull: Bridging the translational gap: an operational classification and quantitative framework for accelerating enteric vaccine research using animal models. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Koley H – PersonEntity: Name: NameFull: Mukherjee A – PersonEntity: Name: NameFull: Mukhopadhyay AK – PersonEntity: Name: NameFull: Das S – PersonEntity: Name: NameFull: Howlader DR IsPartOfRelationships: – BibEntity: Dates: – D: 24 M: 10 Text: 2026 Oct 24 Type: published Y: 2026 Identifiers: – Type: issn-electronic Value: 1873-2518 Numbering: – Type: volume Value: 92 Titles: – TitleFull: Vaccine Type: main |
| ResultId | 1 |