Trial reportBMC infectious diseases2014
Experimental infection of healthy volunteers with enterotoxigenic Escherichia coli wild-type strain TW10598 in a hospital ward.
Trial report in BMC infectious diseases, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02870751 (Developing A Human Challenge Model For Evaluating Vaccines Against ST-producing Enterotoxigenic Escherichia Coli), which is not on this map. Cited by 16 papers.
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.
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.
Developing A Human Challenge Model For Evaluating Vaccines Against ST-producing Enterotoxigenic Escherichia Coli
Who cites it
16 citing papers in PubMed, 18 citations in OpenAlex.
- 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 neglected tropical diseases · 2019Trial
- Enterotoxigenic Escherichia coli-blood group A interactions intensify diarrheal severity.The Journal of clinical investigation · 2018Trial
- Role of cellular effectors in the induction and maintenance of IgA responses leading to protective immunity against enteric bacterial pathogens.Frontiers in immunology · 2024Review
- The Controlled Human Infection Model for Enterotoxigenic Escherichia coli.Current topics in microbiology and immunology · 2024Review
- Strong Association between Diarrhea and Concentration of EnterotoxigenicPathogens (Basel, Switzerland) · 2023Article
- Controlled Human Infection Models To Accelerate Vaccine Development.Clinical microbiology reviews · 2022Review
- Human Mucosal IgA Immune Responses against EnterotoxigenicPathogens (Basel, Switzerland) · 2020Review
- Experimental Infection of Human Volunteers with the Heat-Stable Enterotoxin-Producing EnterotoxigenicPathogens (Basel, Switzerland) · 2019Article
- Development of an enterotoxigenicHuman vaccines & immunotherapeutics · 2019Review
- A roadmap for enterotoxigenicHuman vaccines & immunotherapeutics · 2019Review
- Critical Role of Zinc in a New Murine Model of Enterotoxigenic Escherichia coli Diarrhea.Infection and immunity · 2018Article
- Proliferation of enterotoxigenicGut pathogens · 2018Article
- Impact of CD4+ T Cell Responses on Clinical Outcome following Oral Administration of Wild-Type Enterotoxigenic Escherichia coli in Humans.PLoS neglected tropical diseases · 2017Article
- Salivary IgA from the sublingual compartment as a novel noninvasive proxy for intestinal immune induction.Mucosal immunology · 2016Article
- An Evidenced-Based Scale of Disease Severity following Human Challenge with Enteroxigenic Escherichia coli.PloS one · 2016Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 6 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEnterotoxigenic 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.
methodsAn 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.
resultsWe 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.
conclusionsWe 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.
Indexed as
Identifiers
What OpenQuestion holds
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.