Trial reportVaccine2021
Safety and immunogenicity of intramuscularly administered CS6 subunit vaccine with a modified heat-labile enterotoxin from enterotoxigenic Escherichia coli.
Trial report in Vaccine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 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.
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Who cites it
32 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
- Trial
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- A 25-year landscape of Escherichia coli vaccine development: systematic review of human clinical studies.NPJ vaccines · 2026Article
- Vaccine Candidates Designed to Prevent Enterotoxigenic Escherichia coli Diarrhoea: A Scoping Review of Clinical Trials Evaluating Vaccine Candidates in Development.Tropical medicine & international health : TM & IH · 2026Article
- MVA-Spike encoding the A subunit of dmLT safely enhances systemic and mucosal immune responses.Frontiers in immunology · 2026Article
- Recent progress in enterotoxigenicInfection and immunity · 2025Review
- Immunogenicity and preclinical efficacy characterization of ShecVax, a combined vaccine againstInfection and immunity · 2025Article
- Parenteral vaccination with recombinant EtpA glycoprotein impairs enterotoxigenicInfection and immunity · 2025Article
- Conserved antigens for enteric vaccines.Vaccine · 2025Review
- Review
- Safety and immunogenicity in humans of enterotoxigenic Escherichia coli double mutant heat-labile toxin administered intradermally.NPJ vaccines · 2025Article
- Safety, Tolerability, and Immunogenicity of the InvaplexVaccines · 2025Article
- Safety and immunogenicity of a recombinant double-mutant heat-labile toxin derived from enterotoxigenicFrontiers in bacteriology · 2025Article
- Special Issue on EnterotoxigenicMicroorganisms · 2024Article
- Progress toward a vaccine for extraintestinal pathogenicInfection and immunity · 2024Article
- Efficacy Evaluation of an Intradermally Delivered EnterotoxigenicMicroorganisms · 2024Article
- Recent advances in enterotoxin vaccine adjuvants.Current opinion in immunology · 2023Review
- A broadly immunogenic polyvalentInfection and immunity · 2023Article
- Protein-based vaccine candidate MecVax broadly protects against enterotoxigenicInfection and immunity · 2023Article
Corrections and comments
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Authors and funding
16 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionEnterotoxigenic Escherichia coli (ETEC) is a common cause of infectious diarrhoea and a leading cause of morbidity and mortality in children living in resource-limited settings. It is also the leading cause of travellers' diarrhoea among civilian and military travellers. Its dual importance in global public health and travel medicine highlights the need for an effective vaccine. ETEC express colonization factors (CFs) that mediate adherence to the small intestine. An epidemiologically prevalent CF is coli surface antigen 6 (CS6). We assessed the safety and immunogenicity of a CS6-targeted candidate vaccine, CssBA, co-administered intramuscularly with the double-mutant heat-labile enterotoxin, dmLT [LT(R192G/L211A)].
methodsThis was an open-label trial. Fifty subjects received three intramuscular injections (Days 1, 22 and 43) of CssBA alone (5 µg), dmLT alone (0.1 µg) or CssBA (5, 15, 45 µg) + dmLT (0.1 and 0.5 µg). Subjects were actively monitored for adverse events for 28 days following the third vaccination. Antibody responses (IgG and IgA) were characterized in the serum and from lymphocyte supernatants (ALS) to CS6 and the native ETEC heat labile enterotoxin, LT.
resultsAcross all dose cohorts, the vaccine was safe and well-tolerated with no vaccine-related severe or serious adverse events. Among vaccine-related adverse events, a majority (98%) were mild with 79% being short-lived vaccine site reactions. Robust antibody responses were induced in a dose-dependent manner with a clear dmLT adjuvant effect. Response rates in subjects receiving 45 µg CssBA and 0.5 µg dmLT ranged from 50 to 100% across assays.
conclusionThis is the first study to demonstrate the safety and immunogenicity of CssBA and/or dmLT administered intramuscularly. Co-administration of the two components induced robust immune responses to CS6 and LT, paving the way for future studies to evaluate the efficacy of this vaccine target and development of a multivalent, subunit ETEC vaccine.
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