Evidence map›Paper›PMID 39934422›Full record

Trial reportMedical microbiology and immunology2025

Protective antibodies against enterotoxigenic Escherichia coli are generated from heat-labile toxoid vaccination and exhibit subject- and vaccine-specific diversity.

Milton Maciel, Jordan C Scott, Robin L Baudier, John D Clements, Renee M Laird, Ramiro L Gutiérrez, Chad K Porter, Elizabeth B Norton

Abstract readClinical Trial, Phase IIClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Medical microbiology and immunology, 2025. 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. Trial
  2. Recent progress in enterotoxigenicInfection and immunity · 2025
    Review
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

8 authors.

Milton Maciel *Operationally Relevant Infections Department, Naval Medical Research Command, Silver Spring, MD, USA.
Jordan C Scott *Department of Microbiology and Immunology, Tulane University School of Medicine, New Orleans, LA, USA.
Robin L BaudierDepartment of Microbiology and Immunology, Tulane University School of Medicine, New Orleans, LA, USA.
John D ClementsDepartment of Microbiology and Immunology, Tulane University School of Medicine, New Orleans, LA, USA.
Renee M LairdOperationally Relevant Infections Department, Naval Medical Research Command, Silver Spring, MD, USA.
Ramiro L GutiérrezOperationally Relevant Infections Department, Naval Medical Research Command, Silver Spring, MD, USA.
Chad K PorterTranslational and Clinical Research Department, Naval Medical Research Command, Silver Spring, MD, USA.
Elizabeth B NortonDepartment of Microbiology and Immunology, Tulane University School of Medicine, New Orleans, LA, USA. enorton@tulane.edu.

Funding

Evaluation of Memory Responses and Biomarkers from a Phase IEnterotoxigenic Escherichia coli (ETEC) Intramuscular SubunitVaccine with dmLT AdjuvantR01AI166682 · NIAID · TULANE UNIVERSITY OF LOUISIANA · PI NORTON, ELIZABETH B · 2021 to 2025
$3.5M
National Institute of Allergy and Infectious Diseases R01AI166682NIAID NIH HHS R01 AI166682
6 · The paper itself

Abstract

Heat-labile toxin (LT) from enterotoxigenic Escherichia coli (ETEC) is an important pathogenic protein. Anti-LT antibodies (Abs) induced by vaccination can neutralize the toxin and potentially prevent diarrheal secretion from ~ 60% of ETEC strains expressing LT. However, only superficial investigation of the anti-toxin response is usually conducted in clinical trials. Here, we utilized human serum samples from two clinical trials performed to assess safety, immunogenicity and protection in a controlled human infection model with a LT + ST + CFA/I + H10407 ETEC strain. These Phase 1 and Phase 2b clinical trials explored a prototype ETEC adhesin (CfaE) and a chimeric adhesin-toxoid protein (dscCfaE-CTA2/LTB5) delivered intradermally or transcutaneously with a mutated form of LT (mLT) as an adjuvant. Serum samples were tested for antigen-specific IgG or IgA Abs by immunoblot, enzyme-linked immunosorbent assay (ELISA), or functional neutralizing Abs using LT holotoxin, LTA or LTB subunits. Abs to both LT subunits were present, but the response to each was altered by vaccine formulation, dose, and delivery routes as well as subject. The anti-LT IgG response correlated best to neutralizing antibodies and protection from H10407 controlled challenge when compared to other measures including serum IgA or anti-fimbriae (CfaE) Abs. In addition, our results helped to explain cohort attack rate differences in naïve unvaccinated participants and we found higher anti-LTA IgG post-challenge significantly related to ETEC severity score. Thus, strategies generating and measuring immunity to the complete AB

Indexed as

Antibodies, BacterialBacterial ToxinsEnterotoxigenic Escherichia coliEnterotoxinsEscherichia coli InfectionsEscherichia coli ProteinsEscherichia coli VaccinesToxoidsAdultAntibodies, NeutralizingEnzyme-Linked Immunosorbent AssayFemaleFimbriae ProteinsHumansImmunoglobulin AImmunoglobulin GAntibodies, BacterialAntibodies, NeutralizingBacterial ToxinsEnterotoxinsEscherichia coli ProteinsEscherichia coli VaccinesFimbriae Proteinsheat-labile enterotoxin, E coliImmunoglobulin AImmunoglobulin GToxoidsAntibodiesControlled human challengeDiarrheal diseaseETECHeat-labile toxinVaccination

Identifiers

PMID39934422
PMCPMC11814043

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Registered trials

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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.