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dc.contributor.authorSkrede, Steinaren_US
dc.contributor.authorSteinsland, Hansen_US
dc.contributor.authorSommerfelt, Halvoren_US
dc.contributor.authorAase, Audunen_US
dc.contributor.authorBrandtzaeg, Peren_US
dc.contributor.authorLangeland, Ninaen_US
dc.contributor.authorCox, Rebecca Janeen_US
dc.contributor.authorSævik, Marianneen_US
dc.contributor.authorWallevik, Maritaen_US
dc.contributor.authorSkutlaberg, Dag Haralden_US
dc.contributor.authorTellevik, Marit Gjerdeen_US
dc.contributor.authorSack, David A.en_US
dc.contributor.authorNataro, James P.en_US
dc.contributor.authorGuttormsen, Anne Beriten_US
dc.description.abstractBackground: 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.en_US
dc.publisherBioMed Centraleng
dc.rightsAttribution CC BYeng
dc.subjectExperimental infectioneng
dc.titleExperimental infection of healthy volunteers with enterotoxigenic Escherichia coli wild-type strain TW10598 in a hospital warden_US
dc.typePeer reviewed
dc.typeJournal article
dc.rights.holderCopyright 2014 Skrede et al.; licensee BioMed Central Ltd.
dc.rights.holderSteinar Skrede et al.; licensee BioMed Central Ltd.
dc.source.journalBMC Infectious Diseases

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