ArticleVaccine2019
Live attenuated enterotoxigenic Escherichia coli (ETEC) vaccine with dmLT adjuvant protects human volunteers against virulent experimental ETEC challenge.
Article in Vaccine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01739231 (Safety, Reactogenicity, Tolerability, Immunogenicity and Efficacy of Live Attenuated ETEC ACE527 Vaccine Administered Alone or With a Double Mutant E. Coli Heat Labile Toxin), which is not on this map. Cited by 60 papers.
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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.
Safety, Reactogenicity, Tolerability, Immunogenicity and Efficacy of Live Attenuated ETEC ACE527 Vaccine Administered Alone or With a Double Mutant E. Coli Heat Labile Toxin (dmLT) in Healthy Adult Volunteers
Who cites it
60 citing papers in PubMed, 73 citations in OpenAlex.
- The case for evaluation of double mutant heat-labile toxin as an adjuvant to improve oral cholera vaccine immunogenicity.Frontiers in immunology · 2026Trial
- 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
- Flagellar regulation in enterotoxigenicInfection and immunity · 2026Article
- Emerging and Underdetected Colonization Factors in EnterotoxigenicMicroorganisms · 2026Review
- Th1 and Th17 Responses to LTB and Colonization Factors Following Oral ETEC Vaccination.Microorganisms · 2026Article
- A 25-year landscape of Escherichia coli vaccine development: systematic review of human clinical studies.NPJ vaccines · 2026Article
- 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
- Advances in vaccine adjuvant development and future perspectives.Drug delivery · 2025Review
- Conserved antigens for enteric vaccines.Vaccine · 2025Review
- Review
- Safety and immunogenicity of a recombinant double-mutant heat-labile toxin derived from enterotoxigenicFrontiers in bacteriology · 2025Article
- Coupling enterotoxigenic Escherichia coli heat-stable peptide toxin with 8-arm PEG enhances immunogenicity.Journal of peptide science : an official publication of the European Peptide Society · 2025Article
- Host-derived CEACAM-laden vesicles engage enterotoxigenicProceedings of the National Academy of Sciences of the United States of America · 2024Article
- Host-derived CEACAM-laden vesicles engage enterotoxigenicbioRxiv : the preprint server for biology · 2024Article
- Epidemiology of EnterotoxigenicMicroorganisms · 2024Article
- Oral administration of a recombinant modified RBD antigen of SARS-CoV-2 as a possible immunostimulant for the care of COVID-19.Microbial cell factories · 2024Article
- The Controlled Human Infection Model for Enterotoxigenic Escherichia coli.Current topics in microbiology and immunology · 2024Review
- Age-dependent pathogenic profiles of enterotoxigenicFrontiers in public health · 2024Article
- Epidemiology of enterotoxigenicFrontiers in public health · 2024Article
Corrections and comments
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Authors and funding
13 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThere is no licensed vaccine against enterotoxigenic Escherichia coli (ETEC), a major cause of diarrhea-associated morbidity and mortality among infants and children in low-income countries and travelers. The results of this vaccination/challenge study demonstrate strong protection by an attenuated ETEC vaccine candidate, ACE527, when co-administered with a mucosal adjuvant, the double-mutant heat-labile toxin (dmLT) of ETEC.
methodsSixty healthy adults participated in a randomized, placebo-controlled, double-blind study with three doses of lyophilized ACE527 (∼3 × 10
findingsThe vaccine was well tolerated and induced robust immune responses to key antigens. The protective efficacy (PE) against the primary outcome of severe diarrhea was 65.9% (95% confidence interval [CI] 5.4-87.7, p = 0.003). Among subjects receiving the adjuvanted vaccine, the attack rate of severe diarrhea was 23.1, while in unimmunized controls it was 67.7%. The PE against diarrhea of any severity was 58.5% (95% CI 3.8- 82.1, p = 0.016). There was a strong inverse correlation between shedding of the vaccine strain after either of the first two doses and absence of severe diarrhea upon challenge (RR = 0.29, 95% CI 0.08-1.05, p = 0.041). Challenge strain shedding was 10-fold lower in those receiving the adjuvant than in those receiving vaccine alone. The unadjuvanted vaccine was not protective (PE = 23.1%).
interpretationThe results of this study support further development of ACE527 + dmLT as a vaccine for children in endemic countries and travelers. This is the first clinical demonstration that dmLT can contribute significantly to vaccine efficacy and may warrant testing with other oral vaccines. (ClinicalTrials.gov registration: NCT01739231).
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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.