Trial reportClinical and vaccine immunology : CVI2012
The oral, live attenuated enterotoxigenic Escherichia coli vaccine ACE527 reduces the incidence and severity of diarrhea in a human challenge model of diarrheal disease.
Trial report in Clinical and vaccine immunology : CVI, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 65 papers, 1 of them a synthesis that pooled it.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
65 citing papers in PubMed, 1 synthesis or guideline pooled it, 101 citations in OpenAlex.
- Vaccines for preventing enterotoxigenic Escherichia coli (ETEC) diarrhoea.The Cochrane database of systematic reviews · 2013Pooled it
- Characterization of the pathophysiological determinants of diarrheagenic Escherichia coli infection using a challenge model in healthy adults.Scientific reports · 2021Trial
- Refinement of the CS6-expressing enterotoxigenic Escherichia coli strain B7A human challenge model: A randomized trial.PloS one · 2020Trial
- 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
- Review
- Influence of Gut Microbiota on Immune Responses and Protection in Volunteers Receiving the Live Attenuated Oral ETEC Vaccine ACE257 followed by Virulent ETEC H10407 Challenge.Research square · 2026Article
- Recent progress in enterotoxigenicInfection and immunity · 2025Review
- Self-assembling TLR2 agonists promote mucosal immune responses without pulmonary immunopathologic injuries in mice.NPJ vaccines · 2025Article
- Symptoms and adverse events in controlled human infection models.Frontiers in medicine · 2025Review
- Proportions of IgA antibodies targeting glycosylated epitopes of secreted Escherichia coli mucinase YghJ in initial plasmablast response differ from salivary and intestinally secreted IgA.Medical microbiology and immunology · 2024Article
- Application of a Novel Proteomic Microarray Reveals High Exposure to DiarrhoeagenicMicroorganisms · 2024Article
- The Controlled Human Infection Model for Enterotoxigenic Escherichia coli.Current topics in microbiology and immunology · 2024Review
- Epidemiology of enterotoxigenicFrontiers in public health · 2024Article
- Strong Association between Diarrhea and Concentration of EnterotoxigenicPathogens (Basel, Switzerland) · 2023Article
- A low-cost recombinant glycoconjugate vaccine confers immunogenicity and protection against enterotoxigenicFrontiers in molecular biosciences · 2023Article
- Controlled Human Infection Models To Accelerate Vaccine Development.Clinical microbiology reviews · 2022Review
- Evaluation of Multivalent EnterotoxigenicApplied and environmental microbiology · 2022Article
- Whole Genome Sequencing and CRISPR/Cas9 Gene Editing of EnterotoxigenicInternational journal of molecular sciences · 2022Article
5 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
An oral, live attenuated, three-strain recombinant bacterial vaccine, ACE527, was demonstrated to generate strong immune responses to colonization factor and toxin antigens of enterotoxigenic Escherichia coli (ETEC) in human volunteers. The vaccine was safe and well tolerated at doses of up to 10(11) CFU, administered in each of two doses given 21 days apart. These observations have now been extended in a phase 2b study with a total of 70 subjects. Fifty-six of these subjects were challenged 28 days after the second dose of vaccine with the highly virulent ETEC strain H10407 to obtain preliminary indicators of efficacy against disease and to support further development of the vaccine for both travelers and infants in countries where ETEC is endemic. The vaccine had a significant impact on intestinal colonization by the challenge strain, as measured by quantitative fecal culture 2 days after challenge, demonstrating the induction of a functional immune response to the CFA/I antigen. The incidence and severity of diarrhea were also reduced in vaccinees as measured by a number of secondary and ad hoc endpoints, although the 27% reduction seen in the primary endpoint, moderate to severe diarrhea, was not statistically significant. Together, these observations support the hypothesis that the ACE527 vaccine has a dual mode of action, targeting both colonization factors and the heat-labile enterotoxin (LT), and suggest that it should be further developed for more advanced trials to evaluate its impact on the burden of ETEC disease in field settings.
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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.