ArticleMicroorganisms2023
A First in Human Clinical Trial Assessing the Safety and Immunogenicity of Two Intradermally Delivered Enterotoxigenic
Article in Microorganisms, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
What it found
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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.
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.
Who cites it
10 citing papers in PubMed, 8 citations in OpenAlex.
- Protective antibodies against enterotoxigenic Escherichia coli are generated from heat-labile toxoid vaccination and exhibit subject- and vaccine-specific diversity.Medical microbiology and immunology · 2025Trial
- Review
- A 25-year landscape of Escherichia coli vaccine development: systematic review of human clinical studies.NPJ vaccines · 2026Article
- Recent progress in enterotoxigenicInfection and immunity · 2025Review
- The Central Importance of Vaccines to Mitigate the Threat of Antibiotic-Resistant Bacterial Pathogens.Vaccines · 2025Review
- Conserved antigens for enteric vaccines.Vaccine · 2025Review
- Review
- Safety and immunogenicity in humans of enterotoxigenic Escherichia coli double mutant heat-labile toxin administered intradermally.NPJ vaccines · 2025Article
- Safety and immunogenicity of a recombinant double-mutant heat-labile toxin derived from enterotoxigenicFrontiers in bacteriology · 2025Article
- Efficacy Evaluation of an Intradermally Delivered EnterotoxigenicMicroorganisms · 2024Article
Corrections and comments
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Authors and funding
10 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionEnterotoxigenic
methodsCfaE was evaluated as a donor strand-complemented construct (dscCfaE) and as a chimeric construct (Chimera) in which dscCfaE replaces the A1 domain of the cholera toxin A subunit and assembles non-covalently with the pentamer of heat-labile toxin B (LTB). Subjects received three ID vaccinations three weeks apart with either dscCfaE (1, 5, and 25 µg) or Chimera (2.6 and 12.9 µg) with and without 0.1 µg of mLT. Subjects were monitored for local and systemic adverse events. Immunogenicity was evaluated by serum and antibody-secreting cell (ASC) responses.
resultsThe vaccine was well-tolerated with predominantly mild and moderate local vaccine site reactions characterized by erythema, induration and post-inflammatory hyperpigmentation. High rates of serologic and ASC responses were seen across study groups with the most robust responses observed in subjects receiving 25 µg of dscCfaE with 0.1 mcg of LT(R192G).
conclusionBoth ETEC adhesin vaccine prototypes were safe and immunogenic when co-administered with mLT by the ID route. The observed immune responses induced with the high dose of dscCfaE and mLT warrant further assessment in a controlled human infection model.
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Registered trials
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.