Evidence map›Paper›PMID 41575733›Full record

ArticleTropical medicine & international health : TM & IH2026

Vaccine Candidates Designed to Prevent Enterotoxigenic Escherichia coli Diarrhoea: A Scoping Review of Clinical Trials Evaluating Vaccine Candidates in Development.

Vaidehi Nafade, Naheemot O Sule, Yang Zhang, Angelina Sassi, Nicole E Basta

Abstract readScoping Review
In one paragraph

Article in Tropical medicine & international health : TM & IH, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Vaidehi NafadeDepartment of Epidemiology, Biostatistics and Occupational Health, School of Population and Global Health, Faculty of Medicine and Health Sciences, McGill University, Montreal, Quebec, Canada.
Naheemot O SuleDepartment of Epidemiology, Biostatistics and Occupational Health, School of Population and Global Health, Faculty of Medicine and Health Sciences, McGill University, Montreal, Quebec, Canada.
Yang ZhangDepartment of Epidemiology, Biostatistics and Occupational Health, School of Population and Global Health, Faculty of Medicine and Health Sciences, McGill University, Montreal, Quebec, Canada.
Angelina SassiDepartment of Epidemiology, Biostatistics and Occupational Health, School of Population and Global Health, Faculty of Medicine and Health Sciences, McGill University, Montreal, Quebec, Canada.
Nicole E BastaDepartment of Epidemiology, Biostatistics and Occupational Health, School of Population and Global Health, Faculty of Medicine and Health Sciences, McGill University, Montreal, Quebec, Canada.ORCID https://orcid.org/0000-0002-4951-6353

Funding

Tier 2 Canada Research Chair
6 · The paper itself

Abstract

objectivesThe primary objectives of this study are to (1) summarise the current landscape of ETEC vaccine development by describing, characterising and comparing ETEC vaccine candidates in clinical development, (2) assess key characteristics of the phases 1, 2 and 3 clinical trials that have been designed to evaluate ETEC vaccines in development and (3) compare ETEC vaccine candidates being evaluated in clinical trials to the WHO Preferred Product Characteristics (PPC) for an ETEC vaccine.

methodsTo identify vaccine candidates, we searched 24 trial registries and PubMed. Searches were completed on 6 February 2024 and updated on 27 September 2024. We extracted information about the characteristics of each vaccine candidate and information about the most recently registered clinical trial for candidates in active development. We qualitatively synthesised the information available and compared each vaccine candidate to the WHO PPC.

resultsOur search returned 262 trial records and 821 publications, from which we identified 13 unique vaccine candidates with clinical development spanning three decades, with six vaccine candidates that had at least one clinical trial registered in 2014 or later. These six candidates (dmLT, dscCfAE, ETVAX, CssBA, CVD1208S-122 and ShigETEC) are in Phase 1 or Phase 2 trials with sample sizes from 50 to 4936 participants, with no Phase 3 trials registered by September 2024. Trials take place in the United States, Bangladesh and the Gambia. The candidates vary in their route of administration (oral, intradermal, intramuscular). Two candidates are being evaluated as two doses with or without a booster, and four require three doses. Three candidates are adjuvanted. Most trials are evaluating endpoints about safety and reactogenicity.

conclusionsWe identified diverse ETEC vaccine candidates. Comparison with the PPC emphasised differences in approach and the limited information available from early-stage trials, and the importance of generating evidence for populations with a high burden of ETEC diarrhoea.

Indexed as

DiarrheaEnterotoxigenic Escherichia coliEscherichia coli InfectionsEscherichia coli VaccinesVaccine DevelopmentClinical Trials as TopicHumansEscherichia coli Vaccinesbacterial pathogensclinical trialETECtraveller's diarrhoeavaccine candidatevaccine development

Identifiers

PMID41575733
PMCPMC12963038

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.