Trial reportClinical and vaccine immunology : CVI2011
Refinement of a human challenge model for evaluation of enterotoxigenic Escherichia coli vaccines.
Trial report in Clinical and vaccine immunology : CVI, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 54 papers.
What it found
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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.
Validation of Low-dose ETEC Challenge Model in U.S. Adults and Re-challenge of Immune Subjects With a Homologous ETEC Strain (H10407)
Human Challenge Model Refinement for B7A, An Enterotoxigenic Escherichia Coli (ETEC) Challenge Strain That Expresses CS6
Who cites it
54 citing papers in PubMed.
- Protective antibodies against enterotoxigenic Escherichia coli are generated from heat-labile toxoid vaccination and exhibit subject- and vaccine-specific diversity.Medical microbiology and immunology · 2025Trial
- An emm-type specific qPCR to track bacterial load during experimental human Streptococcus pyogenes pharyngitis.BMC infectious diseases · 2021Trial
- Characterization of the pathophysiological determinants of diarrheagenic Escherichia coli infection using a challenge model in healthy adults.Scientific reports · 2021Trial
- Oral delivery of Hyperimmune bovine serum antibodies against CS6-expressing enterotoxigenicGut microbes · 2020Trial
- Homologous and heterologous re-challenge with Salmonella Typhi and Salmonella Paratyphi A in a randomised controlled human infection model.PLoS neglected tropical diseases · 2020Trial
- Refinement of the CS6-expressing enterotoxigenic Escherichia coli strain B7A human challenge model: A randomized trial.PloS one · 2020Trial
- 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
- EnterotoxigenicProceedings of the National Academy of Sciences of the United States of America · 2018Trial
- Enterotoxigenic Escherichia coli-blood group A interactions intensify diarrheal severity.The Journal of clinical investigation · 2018Trial
- Impact of lower challenge doses of enterotoxigenic Escherichia coli on clinical outcome, intestinal colonization and immune responses in adult volunteers.PLoS neglected tropical diseases · 2018Trial
- Characterization of Mucosal Immune Responses to Enterotoxigenic Escherichia coli Vaccine Antigens in a Human Challenge Model: Response Profiles after Primary Infection and Homologous Rechallenge with Strain H10407.Clinical and vaccine immunology : CVI · 2016Trial
- Experimental infection of healthy volunteers with enterotoxigenic Escherichia coli wild-type strain TW10598 in a hospital ward.BMC infectious diseases · 2014Trial
- The oral, live attenuated enterotoxigenic Escherichia coli vaccine ACE527 reduces the incidence and severity of diarrhea in a human challenge model of diarrheal disease.Clinical and vaccine immunology : CVI · 2012Trial
- A combination vaccine consisting of three live attenuated enterotoxigenic Escherichia coli strains expressing a range of colonization factors and heat-labile toxin subunit B is well tolerated and immunogenic in a placebo-controlled double-blind phase I trial in healthy adults.Clinical and vaccine immunology : CVI · 2011Trial
- Flagellar regulation in enterotoxigenicInfection and immunity · 2026Article
- Intestinal inflammation induced by heat-labile toxin-producing enterotoxigenic E: Coli infection and impact on immune responses in an experimental human challenge model.PLoS neglected tropical diseases · 2025Article
- ETEC biofilms are regulated by magnesium and lactate bioavailability.Infection and immunity · 2025Article
- Review
- Efficacy Evaluation of an Intradermally Delivered EnterotoxigenicMicroorganisms · 2024Article
- The Controlled Human Infection Model for Enterotoxigenic Escherichia coli.Current topics in microbiology and immunology · 2024Review
Corrections and comments
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Authors and funding
11 authors.
Funding
Abstract
Enterotoxigenic Escherichia coli (ETEC) strain H10407 (serotype O78:H11 producing heat-labile toxin [LT], heat-stable toxin [ST], and colonization factor I [CFA/I]) induces reliably high diarrheal attack rates (ARs) in a human challenge model at doses of ≥10(9) CFU. A descending-dose challenge study was conducted with changes to the standard fasting time and buffer formulation, seeking conditions that permit lower inocula while maintaining reproducibly high ARs. In cohort 1, 20 subjects were fasted overnight and randomized 1:1:1:1 to receive H10407 at doses of 10(8) CFU with bicarbonate, 10(8) CFU with CeraVacx, 10(7) CFU with bicarbonate, or 10(7) CFU with CeraVacx. Subsequent cohorts received H10407 (10(7) CFU with bicarbonate) with similar fasting conditions. Cohort 2 included 15 ETEC-naïve volunteers. Cohort 3 included 10 ETEC-naïve volunteers and 10 rechallenged volunteers. In all, 25/35 (71%) ETEC-naïve recipients of 10(7) CFU of H10407 developed moderate or severe diarrhea (average maximum stool output/24 h = 1,042 g), and most (97%) shed H10407 (maximum geometric mean titer = 7.5 × 10(7) CFU/gram of stool). Only one of 10 rechallenged volunteers developed diarrhea. These rechallenged subjects had reduced intestinal colonization, reflected by quantitative microbiology of fecal samples. Among the 35 ETEC-naïve subjects, anti-lipopolysaccharide (LPS) O78 serum antibody responses were striking, with positive IgA and IgG antibody responses in 33/35 (94%) and 25/35 (71%), respectively. Anti-heat-labile enterotoxin (LTB) serum IgA and IgG responses developed in 19/35 (54%) and 14/35 (40%) subjects, respectively. Anti-CFA/I serum IgA and IgG responses were detected in 15/35 (43%) and 8/35 (23%) subjects. After the second challenge, participants exhibited blunted anti-LPS and -LTB responses but a booster response to CFA/I. This ETEC model should prove useful in the future evaluation of ETEC vaccine candidates.
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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.