Experimental infection of healthy volunteers with enterotoxigenic Escherichia coli wild-type strain TW10598 in a hospital ward

Steinar Skrede, Hans Steinsland, Halvor Sommerfelt, Audun Aase, Per Brandtzaeg, Nina Langeland, Rebecca J. Cox, Marianne Sævik, Marita Wallevik, Dag H. Skutlaberg, Marit G. Tellevik, David A. Sack, James P. Nataro, Anne B. Guttormsen

Research output: Contribution to journalArticlepeer-review

14 Scopus citations


Background: Enterotoxigenic Escherichia coli (ETEC) is an important cause of childhood diarrhea in resource-limited regions. It is also an important cause of diarrhea in travellers to these areas. To evaluate the protective efficacy of new ETEC vaccines that are under development, there is a need to increase the capacity to undertake Phase IIB (human challenge) clinical trials and to develop suitable challenge models. Methods: An in-hospital study was performed where fasting adult volunteers were experimentally infected with 1 × 106 to 1 × 109 colony forming units (CFUs) of the wild-type ETEC strain TW10598, which had been isolated from a child with diarrhea in West Africa in 1997. We recorded symptoms and physical signs and measured serum immune response to the TW10598 bacterium. Results: We included 30 volunteers with mean age 22.8 (range 19.8, 27.4) years. The most common symptoms were diarrhea (77%), abdominal pain (67%), nausea (63%), and abdominal cramping (53%). Seven subjects (23%) experienced fever, none were hypotensive. Most of the volunteers responded with a substantial rise in the level of serum IgA antibodies against the challenge strain. Conclusions: We established the capacity and methods for safely undertaking challenge studies to measure the efficacy of ETEC vaccine candidates in a hospital ward. Strain TW10598 elicited both clinical symptoms and an immune response across the doses given.

Original languageEnglish (US)
Article number482
JournalBMC infectious diseases
Issue number1
StatePublished - Sep 4 2014


  • Challenge
  • ETEC
  • Experimental infection
  • Inpatient

ASJC Scopus subject areas

  • Infectious Diseases


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