Trial reportInfection and immunity2007
Safety and immunogenicity of an enterotoxigenic Escherichia coli vaccine patch containing heat-labile toxin: use of skin pretreatment to disrupt the stratum corneum.
Trial report in Infection and immunity, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 2 of them syntheses 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
22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 68 citations in OpenAlex.
- Vaccines for preventing enterotoxigenic Escherichia coli (ETEC) diarrhoea.The Cochrane database of systematic reviews · 2013Pooled it
- Oral vaccines for preventing cholera.The Cochrane database of systematic reviews · 2011Pooled it
- Trial
- Safety and immunogenicity in humans of enterotoxigenic Escherichia coli double mutant heat-labile toxin administered intradermally.NPJ vaccines · 2025Article
- Safety and immunogenicity of a recombinant double-mutant heat-labile toxin derived from enterotoxigenicFrontiers in bacteriology · 2025Article
- Article
- Transcutaneous Vaccination with Conjugate Typhoid Vaccine Vi-DT Induces Systemic, Mucosal, and Memory Anti-Polysaccharide Responses.The American journal of tropical medicine and hygiene · 2020Article
- The Current State of Epicutaneous Immunotherapy for Food Allergy: a Comprehensive Review.Clinical reviews in allergy & immunology · 2018Review
- Current Progress in Developing Subunit Vaccines against Enterotoxigenic Escherichia coli-Associated Diarrhea.Clinical and vaccine immunology : CVI · 2015Review
- Article
- Recent advances in understanding enteric pathogenic Escherichia coli.Clinical microbiology reviews · 2013Review
- The A subunit of Escherichia coli heat-labile enterotoxin functions as a mucosal adjuvant and promotes IgG2a, IgA, and Th17 responses to vaccine antigens.Infection and immunity · 2012Article
- Facilitation of transcutaneous drug delivery and vaccine immunization by a safe laser technology.Journal of controlled release : official journal of the Controlled Release Society · 2012Article
- New Developments in Traveler's Diarrhea.Gastroenterology & hepatology · 2011Article
- The extent of the uptake of plasmid into the skin determines the immune responses induced by a DNA vaccine applied topically onto the skin.The Journal of pharmacy and pharmacology · 2011Article
- Antibody against recombinant heat labile enterotoxin B subunit (rLTB) could block LT binding to ganglioside M1 receptor.Iranian journal of microbiology · 2010Article
- Concomitant enterotoxigenic Escherichia coli infection induces increased immune responses to Vibrio cholerae O1 antigens in patients with cholera in Bangladesh.Infection and immunity · 2010Article
- Toxin-mediated effects on the innate mucosal defenses: implications for enteric vaccines.Infection and immunity · 2009Review
- Selective removal of stratum corneum by microdermabrasion to increase skin permeability.European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences · 2009Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Transcutaneous immunization allows safe delivery of native heat-labile enterotoxin (LT) from Escherichia coli via application of a simple patch. Physical disruption of the stratum corneum can improve the efficiency of delivery. In the current study, the stratum corneum was disrupted using an electrocardiogram prep pad prior to patch application. The effects were quantified using transepidermal water loss (TEWL) and were correlated with the immune responses. Sixty adults received 50 microg of LT from three lots of LT (20 adults per group) administered in a patch on days 0 and 21. The immunizations were well tolerated. There were no differences in the anti-LT immunoglobulin G (IgG) titers between the three LT lots; the seroconversion rate was 100%, and the mean anti-LT IgG titer was 12,185 enzyme-linked immunosorbent assay units (EU) (a 24-fold increase). TEWL measurements obtained at the time of the second immunization were found to correlate with the day 42 individual increases in the anti-LT IgG titer (r = 0.59, P < 0.001). In a comparative assessment of the immune responses, sera after an LT+ ST+ (E2447A) oral ETEC challenge, which induced moderate to severe diarrhea in 81% of the recipients, had anti-LT IgG titers of 3,245 EU (a 10.8-fold increase). Similarly, the anti-LT IgG titer after administration of an oral cholera toxin B subunit-containing cholera vaccine, which cross-reacts with LT and protects against LT and LT/heat-stable toxin ETEC disease in the field, was 6,741 EU (a 3.3-fold increase). This study confirmed that a well-tolerated regimen for stratum corneum disruption before vaccine patch application results in robust immunity comparable to natural immunity and vaccine-induced immunity and that the magnitude of stratum corneum disruption correlates with the immune response.
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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.