Trial reportJournal of travel medicine2023
Safety and immunogenicity of ETVAX®, an oral inactivated vaccine against enterotoxigenic Escherichia coli diarrhoea: a double-blinded, randomized, placebo-controlled trial amongst Finnish travellers to Benin, West Africa.
Trial report in Journal of travel medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 1 of them a synthesis that pooled it.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
28 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.
- Bismuth subsalicylate, probiotics, rifaximin and vaccines for the prevention of travelers' diarrhea: a systematic review and network meta-analysis.Frontiers in pharmacology · 2024Pooled it
- Efficacy of ETVAX, a vaccine against enterotoxigenic Escherichia coli-positive diarrhoea in Gambian children: a double-blind, randomised, placebo-controlled, phase 2b trial.The Lancet. Infectious diseases · 2026Trial
- Co-administration of oral killed whole-cell recombinant cholera toxin B-subunit vaccine (WC-rCTB) and live Salmonella Typhi Ty21a vaccine: a prospective randomized open-label trial.Journal of travel medicine · 2026Trial
- The case for evaluation of double mutant heat-labile toxin as an adjuvant to improve oral cholera vaccine immunogenicity.Frontiers in immunology · 2026Trial
- Use of a TaqMan Array Card for identification of enterotoxins and colonization factors directly from stool samples in an enterotoxigenicMicrobiology spectrum · 2025Trial
- Attenuating ETEC virulence using a heat-labile enterotoxin-blocking binding protein.Gut microbes · 2026Article
- Review
- A Functional Limosilactobacillus reuteri ZY18 Strain: Probiotic Properties and Associated Anti-inflammatory Responses Against ETEC K88 Infection.Probiotics and antimicrobial proteins · 2026Article
- ETVAX: From Concepts to Demonstrated Clinical Efficacy.Microorganisms · 2026Review
- One Health Perspective on the EnterotoxigenicMicroorganisms · 2026Review
- A 25-year landscape of Escherichia coli vaccine development: systematic review of human clinical studies.NPJ vaccines · 2026Article
- Improving antibiotic prescribing in LMICs: Insights from an outpatient clinic in Pakistan.New microbes and new infections · 2026Article
- Recent progress in enterotoxigenicInfection and immunity · 2025Review
- Advances in vaccine adjuvant development and future perspectives.Drug delivery · 2025Review
- The Central Importance of Vaccines to Mitigate the Threat of Antibiotic-Resistant Bacterial Pathogens.Vaccines · 2025Review
- Self-assembling TLR2 agonists promote mucosal immune responses without pulmonary immunopathologic injuries in mice.NPJ vaccines · 2025Article
- Parenteral vaccination with recombinant EtpA glycoprotein impairs enterotoxigenicInfection and immunity · 2025Article
- Article
- Article
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 6 institutions in 3 countries.
Funding
Abstract
backgroundNo licensed human vaccines are available against enterotoxigenic Escherichia coli (ETEC), a major diarrhoeal pathogen affecting children in low- and middle-income countries and foreign travellers alike. ETVAX®, a multivalent oral whole-cell vaccine containing four inactivated ETEC strains and the heat-labile enterotoxin B subunit (LTB), has proved promising in Phase 1 and Phase 1/ 2 studies.
methodsWe conducted a Phase 2b double-blinded, randomized, placebo-controlled trial amongst Finnish travellers to Benin, West Africa. This report presents study design and safety and immunogenicity data. Volunteers aged 18-65 years were randomized 1:1 to receive ETVAX® or placebo. They visited Benin for 12 days, provided stool and blood samples and completed adverse event (AE) forms. IgA and IgG antibodies to LTB and O78 lipopolysaccharide (LPS) were measured by electrochemiluminescence.
resultsThe AEs did not differ significantly between vaccine (n = 374) and placebo (n = 375) recipients. Of the solicited AEs, loose stools/diarrhoea (26.7/25.9%) and stomach ache (23.0/20.0%) were reported most commonly. Of all possibly/probably vaccine-related AEs, the most frequent were gastrointestinal symptoms (54.0/48.8%) and nervous system disorders (20.3/25.1%). Serious AEs were recorded for 4.3/5.6%, all unlikely to be vaccine related. Amongst the ETVAX® recipients, LTB-specific IgA antibodies increased 22-fold. For the 370/372 vaccine/placebo recipients, the frequency of ≥2-fold increases against LTB was 81/2.4%, and against O78 LPS 69/2.7%. The majority of ETVAX® recipients (93%) responded to either LTB or O78.
conclusionsThis Phase 2b trial is the largest on ETVAX® undertaken amongst travellers to date. ETVAX® showed an excellent safety profile and proved strongly immunogenic, which encourages the further development of this vaccine.
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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.