---
title: "Clinical development of human vaccine candidates against Shigella flexneri: systematic review of t"
id: "pubmed-42771939"
canonical_url: "https://medichelpline.com/clinical-feed/pubmed-42771939"
content_type: "clinical_feed_article"
specialty: "Infectious Disease"
source_name: "PubMed / NCBI"
source_url: "https://pubmed.ncbi.nlm.nih.gov/42771939/"
doi: "10.1016/j.vaccine.2026.129134"
published_at: "2026-10-24T00:00:00.000Z"
evidence_level: "Systematic Review"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Clinical development of human vaccine candidates against Shigella flexneri: systematic review of t
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/pubmed-42771939
- **Specialty:** [Infectious Disease](https://medichelpline.com/clinical-feed/infectious-disease.md)
- **Primary Source:** PubMed / NCBI
- **Source URL:** [Original Journal Publication](https://pubmed.ncbi.nlm.nih.gov/42771939/)
- **DOI:** [10.1016/j.vaccine.2026.129134](https://doi.org/10.1016%2Fj.vaccine.2026.129134)
- **Published At:** 2026-10-24T00:00:00.000Z
- **Evidence Rating:** Systematic Review
## Executive GIST (TL;DR)
- The systematic review synthesized clinical evidence on human vaccine candidates targeting **Shigella flexneri** across multiple platforms and clinical stages, based on a comprehensive PRISMA-guided search. - Twenty-four clinical trials met inclusion criteria; investigators reported studies spanning live-attenuated, **glycoconjugate**, protein-based, GMMA, and inactivated whole-cell vaccine platforms. - Most candidates demonstrated acceptable safety profiles in the trials reviewed, with measurable systemic immune responses recorded in many studies. - The review team observed that **glycoconjugate** vaccines consistently produced durable humoral responses, while **live-attenuated** candidates tended to induce broader mucosal and cellular immunity. - Considerable heterogeneity existed in vaccine formulations, dosing schedules, immunological endpoints, and follow-up durations, limiting direct cross-trial comparisons. - Only one Phase III trial evaluated clinical efficacy, indicating limited progression of candidates to late-stage development. - The authors argued that advancing S. flexneri vaccine development will require large multicenter efficacy trials, standardized immunological outcome measures, and multivalent strategies to cover strain diversity. - The review did not report specific per-trial sample sizes, dosing regimens, or numeric immunogenicity results in the abstract; those details were not provided in the source abstract. - Authors declared no competing financial interests or personal relationships affecting the work.
## Clinical Analysis & Structured Key Points
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Epub 2026 Sep 22. # Clinical development of human vaccine candidates against Shigella flexneri: a systematic review of clinical trials [Mosayeb Rostamian](https://pubmed.ncbi.nlm.nih.gov/?term=Rostamian+M&cauthor_id=42771939)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42771939/#full-view-affiliation-1 "Infectious Diseases Research Center, Health Policy and Promotion Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran."), [Roya Chegene Lorestani](https://pubmed.ncbi.nlm.nih.gov/?term=Chegene+Lorestani+R&cauthor_id=42771939)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42771939/#full-view-affiliation-2 "Infectious Diseases Research Center, Health Policy and Promotion Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran; Department of Microbiology, School of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran; Student Research Committee, Kermanshah University of Medical Sciences, Kermanshah, Iran."), [Tayebe Shahbazi](https://pubmed.ncbi.nlm.nih.gov/?term=Shahbazi+T&cauthor_id=42771939)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42771939/#full-view-affiliation-3 "Pediatric Infectious Diseases, Institute of Immunology and Infectious Diseases, Iran University of Medical Sciences, Tehran, Iran."), [Pourya Mohammadi](https://pubmed.ncbi.nlm.nih.gov/?term=Mohammadi+P&cauthor_id=42771939)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42771939/#full-view-affiliation-1 "Infectious Diseases Research Center, Health Policy and Promotion Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran."), [Shahla Shahbazi](https://pubmed.ncbi.nlm.nih.gov/?term=Shahbazi+S&cauthor_id=42771939)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42771939/#full-view-affiliation-4 "Infectious Diseases Research Center, Health Policy and Promotion Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran. Electronic address: Shahbazi.shahla@yahoo.com."), [Keyghobad Ghadiri](https://pubmed.ncbi.nlm.nih.gov/?term=Ghadiri+K&cauthor_id=42771939)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42771939/#full-view-affiliation-5 "Infectious Diseases Research Center, Health Policy and Promotion Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran. Electronic address: k_ghadiri@yahoo.com.") Affiliations Expand ### Affiliations * 1 Infectious Diseases Research Center, Health Policy and Promotion Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran. * 2 Infectious Diseases Research Center, Health Policy and Promotion Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran; Department of Microbiology, School of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran; Student Research Committee, Kermanshah University of Medical Sciences, Kermanshah, Iran. * 3 Pediatric Infectious Diseases, Institute of Immunology and Infectious Diseases, Iran University of Medical Sciences, Tehran, Iran. * 4 Infectious Diseases Research Center, Health Policy and Promotion Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran. Electronic address: Shahbazi.shahla@yahoo.com. * 5 Infectious Diseases Research Center, Health Policy and Promotion Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran. Electronic address: k_ghadiri@yahoo.com. * PMID: **42771939** * DOI: [ 10.1016/j.vaccine.2026.129134 ](https://doi.org/10.1016/j.vaccine.2026.129134) Item in Clipboard # Clinical development of human vaccine candidates against Shigella flexneri: a systematic review of clinical trials Mosayeb Rostamian et al. Vaccine. 2026. Show details Display options Display options Format Abstract PubMed PMID Vaccine Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Vaccine%22%5Bjour%5D&sort=date&sort_order=desc) * [ Search in NLM Catalog ](https://www.ncbi.nlm.nih.gov/nlmcatalog?term=%22Vaccine%22%5BTitle+Abbreviation%5D) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42771939/) . 2026 Oct 24:92:129134. doi: 10.1016/j.vaccine.2026.129134. Epub 2026 Sep 22. ### Authors [Mosayeb Rostamian](https://pubmed.ncbi.nlm.nih.gov/?term=Rostamian+M&cauthor_id=42771939)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42771939/#short-view-affiliation-1 "Infectious Diseases Research Center, Health Policy and Promotion Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran."), [Roya Chegene Lorestani](https://pubmed.ncbi.nlm.nih.gov/?term=Chegene+Lorestani+R&cauthor_id=42771939)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42771939/#short-view-affiliation-2 "Infectious Diseases Research Center, Health Policy and Promotion Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran; Department of Microbiology, School of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran; Student Research Committee, Kermanshah University of Medical Sciences, Kermanshah, Iran."), [Tayebe Shahbazi](https://pubmed.ncbi.nlm.nih.gov/?term=Shahbazi+T&cauthor_id=42771939)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42771939/#short-view-affiliation-3 "Pediatric Infectious Diseases, Institute of Immunology and Infectious Diseases, Iran University of Medical Sciences, Tehran, Iran."), [Pourya Mohammadi](https://pubmed.ncbi.nlm.nih.gov/?term=Mohammadi+P&cauthor_id=42771939)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42771939/#short-view-affiliation-1 "Infectious Diseases Research Center, Health Policy and Promotion Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran."), [Shahla Shahbazi](https://pubmed.ncbi.nlm.nih.gov/?term=Shahbazi+S&cauthor_id=42771939)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42771939/#short-view-affiliation-4 "Infectious Diseases Research Center, Health Policy and Promotion Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran. Electronic address: Shahbazi.shahla@yahoo.com."), [Keyghobad Ghadiri](https://pubmed.ncbi.nlm.nih.gov/?term=Ghadiri+K&cauthor_id=42771939)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42771939/#short-view-affiliation-5 "Infectious Diseases Research Center, Health Policy and Promotion Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran. Electronic address: k_ghadiri@yahoo.com.") ### Affiliations * 1 Infectious Diseases Research Center, Health Policy and Promotion Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran. * 2 Infectious Diseases Research Center, Health Policy and Promotion Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran; Department of Microbiology, School of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran; Student Research Committee, Kermanshah University of Medical Sciences, Kermanshah, Iran. * 3 Pediatric Infectious Diseases, Institute of Immunology and Infectious Diseases, Iran University of Medical Sciences, Tehran, Iran. * 4 Infectious Diseases Research Center, Health Policy and Promotion Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran. Electronic address: Shahbazi.shahla@yahoo.com. * 5 Infectious Diseases Research Center, Health Policy and Promotion Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran. Electronic address: k_ghadiri@yahoo.com. * PMID: **42771939** * DOI: [ 10.1016/j.vaccine.2026.129134 ](https://doi.org/10.1016/j.vaccine.2026.129134) Item in Clipboard Full text links Cite Display options Display options Format Abstract PubMed PMID Linked Discoveries ## Abstract Shigella flexneri remains a leading cause of shigellosis, particularly in low- and middle-income countries, where it contributes substantially to childhood morbidity, mortality, and the growing burden of antimicrobial resistance. Despite decades of vaccine research, no licensed vaccine against S. flexneri is currently available. This systematic review aimed to summarize and critically evaluate the clinical evidence regarding the safety, immunogenicity, and efficacy of human S. flexneri vaccine candidates. A comprehensive literature search was conducted in major electronic databases following PRISMA guidelines to identify clinical studies evaluating S. flexneri vaccines. Twenty-four eligible clinical trials were included, encompassing live-attenuated, glycoconjugate, protein-based, generalized modules for membrane antigens (GMMA), and inactivated whole-cell vaccine platforms. Overall, most candidates demonstrated acceptable safety profiles and induced measurable systemic and, in several studies, mucosal immune responses. Glycoconjugate vaccines consistently generated durable humoral immunity, while live-attenuated vaccines elicited broader mucosal and cellular responses. However, considerable heterogeneity existed in vaccine formulations, dosing schedules, immunological endpoints, and follow-up periods, limiting direct comparisons across studies. Only one Phase III trial assessed clinical efficacy, highlighting the limited progression of vaccine candidates to advanced clinical evaluation. Collectively, the available evidence supports the continued development of several vaccine platforms. Large multicenter efficacy trials, standardized immunological outcome measures, and multivalent vaccine strategies will be essential to accelerate the development of an effective S. flexneri vaccine. **Keywords:** Clinical trials; Immunogenicity; Shigella flexneri; Shigellosis; Systematic review; Vaccine. Copyright © 2026 Elsevier Ltd. All rights reserved. [PubMed Disclaimer](https://pubmed.ncbi.nlm.nih.gov/disclaimer/) ## Conflict of interest statement 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. ## Similar articles * [ Protein-specific immune response elicited by the _Shigella sonnei_ 1790GAHB GMMA-based candidate vaccine in adults with varying exposure to _Shigella_. ](https://pubmed.ncbi.nlm.nih.gov/40237462/) Randall AZ, Conti V, Nakakana U, Liang X, Teng AA, Di Pasquale AL, Kapulu M, Frenck R Jr, Launay O, Ferruzzi P, Sciré AS, Marchetti E, Obiero C, Pablo JV, Edgar J, Bejon P, Shandling AD, Campo JJ, Yee A, Martin LB, Podda A, Micoli F.Randall AZ, et al.mSphere. 2025 May 27;10(5):e0105724. doi: 10.1128/msphere.01057-24. Epub 2025 Apr 16.mSphere. 2025.PMID: 40237462Free PMC article. * [ Characterization of a multicomponent live, attenuated Shigella flexneri vaccine. ](https://pubmed.ncbi.nlm.nih.gov/27106253/) DeLaine BC, Wu T, Grassel CL, Shimanovich A, Pasetti MF, Levine MM, Barry EM.DeLaine BC, et al.Pathog Dis. 2016 Jul;74(5):ftw034. doi: 10.1093/femspd/ftw034. Epub 2016 Apr 21.Pathog Dis. 2016.PMID: 27106253Free PMC article. * [ Human challenge study with a Shigella bioconjugate vaccine: Analyses of clinical efficacy and correlate of protection. ](https://pubmed.ncbi.nlm.nih.gov/33862589/) Talaat KR, Alaimo C, Martin P, Bourgeois AL, Dreyer AM, Kaminski RW, Porter CK, Chakraborty S, Clarkson KA, Brubaker J, Elwood D, Frölich R, DeNearing B, Weerts H, Feijoo BL, Halpern J, Sack D, Riddle MS, Fonck VG.Talaat KR, et al.EBioMedicine. 2021 Apr;66:103310. doi: 10.1016/j.ebiom.2021.103310. Epub 2021 Apr 13.EBioMedicine. 2021.PMID: 33862589Free PMC article.Clinical Trial. * [ Folic acid supplementation and malaria susceptibility and severity among people taking antifolate antimalarial drugs in endemic areas. ](https://pubmed.ncbi.nlm.nih.gov/36321557/) Crider K, Williams J, Qi YP, Gutman J, Yeung L, Mai C, Finkelstain J, Mehta S, Pons-Duran C, Menéndez C, Moraleda C, Rogers L, Daniels K, Green P.Crider K, et al.Cochrane Database Syst Rev. 2022 Feb 1;2(2022):CD014217. doi: 10.1002/14651858.CD014217.Cochrane Database Syst Rev. 2022.Update in: [Cochrane Database Syst Rev. 2026 Feb 18;2:CD014217. doi: 10.1002/14651858.CD014217.pub2.](https://pubmed.ncbi.nlm.nih.gov/41705996/)PMID: 36321557Free PMC article.Updated. * [ Shigellosis: the current status of vaccine development. ](https://pubmed.ncbi.nlm.nih.gov/18448978/) Kweon MN.Kweon MN.Curr Opin Infect Dis. 2008 Jun;21(3):313-8. doi: 10.1097/QCO.0b013e3282f88b92.Curr Opin Infect Dis. 2008.PMID: 18448978Review. 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