{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,22]],"date-time":"2026-07-22T11:40:56Z","timestamp":1784720456102,"version":"3.55.0"},"reference-count":26,"publisher":"American Society for Microbiology","issue":"1","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Clin. Vaccine Immunol."],"published-print":{"date-parts":[[2015,1]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:p>Enterotoxigenic<jats:named-content content-type=\"genus-species\">Escherichia coli<\/jats:named-content>(ETEC) organisms are a leading cause of infectious diarrhea in developing countries. A live, attenuated cholera strain that expresses high levels of the nontoxic B subunit of cholera toxin, which might also serve as an ETEC protective antigen, was evaluated for safety, excretion, and immunogenicity in healthy volunteers. We enrolled four inpatient dose-escalation cohorts of 15 to 16 eligible subjects to randomly (3:1) receive a single oral dose of vaccine or placebo (buffer alone), evaluating 1 \u00d710<jats:sup>7<\/jats:sup>, 1 \u00d710<jats:sup>8<\/jats:sup>, 1 \u00d710<jats:sup>9<\/jats:sup>, and 1 \u00d710<jats:sup>10<\/jats:sup>CFU of the vaccine. The vaccine was well tolerated, although some subjects experienced moderate diarrhea. The serum Inaba vibriocidal antibody response appeared to display a dose-response relationship with increasing dosages of vaccine, plateauing at the 10<jats:sup>9<\/jats:sup>-CFU dosage. The serum antitoxin (cholera toxin and heat-labile enterotoxin) antibody seroconversion rate (4-fold increase over baseline) also appeared to display a dose-response relationship. The vaccine strain was excreted in stool cultures, displaying a dose-response relationship. A single oral dose of Peru-15 pCTB at dosages up to 1 \u00d710<jats:sup>10<\/jats:sup>CFU was safe and immunogenic in this first-in-human trial. These encouraging data support the ongoing clinical development of this candidate combined cholera and ETEC vaccine. (This study has been registered at ClinicalTrials.gov under registration no. NCT00654108.)<\/jats:p>","DOI":"10.1128\/cvi.00560-14","type":"journal-article","created":{"date-parts":[[2014,11,20]],"date-time":"2014-11-20T07:32:14Z","timestamp":1416468734000},"page":"129-135","source":"Crossref","is-referenced-by-count":17,"title":["Safety and Immunogenicity of Escalating Dosages of a Single Oral Administration of Peru-15 pCTB, a Candidate Live, Attenuated Vaccine against Enterotoxigenic Escherichia coli and Vibrio cholerae"],"prefix":"10.1128","volume":"22","author":[{"given":"Wilbur 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