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Vaccines

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

Wilbur H. Chen, Jose Garza, Monique Choquette, Jennifer Hawkins, Amy Hoeper, David I. Bernstein, Mitchell B. Cohen
D. L. Burns, Editor
Wilbur H. Chen
aCenter for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland, USA
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Jose Garza
bCincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA
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Monique Choquette
bCincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA
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Jennifer Hawkins
bCincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA
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Amy Hoeper
bCincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA
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David I. Bernstein
bCincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA
cDepartment of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA
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Mitchell B. Cohen
bCincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA
cDepartment of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA
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D. L. Burns
Roles: Editor
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DOI: 10.1128/CVI.00560-14
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ABSTRACT

Enterotoxigenic Escherichia coli (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 ×107, 1 ×108, 1 ×109, and 1 ×1010 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 109-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 ×1010 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.)

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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
Wilbur H. Chen, Jose Garza, Monique Choquette, Jennifer Hawkins, Amy Hoeper, David I. Bernstein, Mitchell B. Cohen
Clinical and Vaccine Immunology Dec 2014, 22 (1) 129-135; DOI: 10.1128/CVI.00560-14

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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
Wilbur H. Chen, Jose Garza, Monique Choquette, Jennifer Hawkins, Amy Hoeper, David I. Bernstein, Mitchell B. Cohen
Clinical and Vaccine Immunology Dec 2014, 22 (1) 129-135; DOI: 10.1128/CVI.00560-14
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