A new human challenge model for testing heat-stable toxin-based vaccine candidates for enterotoxigenic Escherichia coli diarrhea - dose optimization, clinical outcomes, and CD4+ T cell responses

PLoS Negl Trop Dis. 2019 Oct 30;13(10):e0007823. doi: 10.1371/journal.pntd.0007823. eCollection 2019 Oct.


ClinicalTrials.gov ClinicalTrials.gov, Project ID: NCT02870751.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antibodies, Bacterial / blood
  • Bacterial Outer Membrane Proteins / immunology
  • CD4-Positive T-Lymphocytes / immunology*
  • Colony Count, Microbial
  • Diarrhea / microbiology
  • Diarrhea / prevention & control
  • Enterotoxigenic Escherichia coli / immunology*
  • Enterotoxins / immunology*
  • Escherichia coli Infections / immunology*
  • Escherichia coli Infections / prevention & control*
  • Escherichia coli Proteins / immunology
  • Escherichia coli Vaccines / administration & dosage*
  • Escherichia coli Vaccines / immunology*
  • Female
  • Hot Temperature
  • Humans
  • Immunoglobulin A / blood
  • Immunoglobulin G / blood
  • Male
  • Metalloproteases
  • Volunteers
  • Young Adult


  • Antibodies, Bacterial
  • Bacterial Outer Membrane Proteins
  • CsfC protein, E coli
  • Enterotoxins
  • Escherichia coli Proteins
  • Escherichia coli Vaccines
  • Immunoglobulin A
  • Immunoglobulin G
  • Metalloproteases
  • YghJ protein, E coli

Associated data

  • ClinicalTrials.gov/NCT02870751

Grant support

This work was partly supported by the Research Council of Norway through the Global Health and Vaccination Programme (GLOBVAC) (https://www.forskningsradet.no/en/), project number 234364. The project has received funding from the European Union’s Seventh Framework Programme (https://ec.europa.eu/research/fp7/index_en.cfm) for research, technological development and demonstration under Grant Agreement no 261472-STOPENTERICS. The project was also supported by funding from the Enteric Vaccine Initiative (EVI) (https://www.path.org/) for the R&D project titled “Developing a safe STh-based vaccine for protection against ETEC diarrhoea”. The contribution by HSo and HSt was in part supported by the Centre for Intervention Science in Maternal and Child Health (CISMAC; project number 223269) (https://www.forskningsradet.no/en/), which is funded by the Research Council of Norway through its Centres of Excellence scheme and the University of Bergen (UiB), Norway. The contribution of STS was in part supported by a PhD grant from the University of Bergen, Norway (https://www.uib.no/). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.