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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.
Clin Vaccine Immunol. 2015 Jan; 22(1):129-35.CV

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 ×10(7), 1 ×10(8), 1 ×10(9), and 1 ×10(10) 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(9)-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 ×10(10) 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.).

Authors+Show Affiliations

Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland, USA.Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA mitchell.cohen@cchmc.org.

Pub Type(s)

Clinical Trial, Phase I
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

25410205

Citation

Chen, Wilbur H., et al. "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." Clinical and Vaccine Immunology : CVI, vol. 22, no. 1, 2015, pp. 129-35.
Chen WH, Garza J, Choquette M, et al. 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. Clin Vaccine Immunol. 2015;22(1):129-35.
Chen, W. H., Garza, J., Choquette, M., Hawkins, J., Hoeper, A., Bernstein, D. I., & Cohen, M. B. (2015). 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. Clinical and Vaccine Immunology : CVI, 22(1), 129-35. https://doi.org/10.1128/CVI.00560-14
Chen WH, et al. 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. Clin Vaccine Immunol. 2015;22(1):129-35. PubMed PMID: 25410205.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Chen,Wilbur H, AU - Garza,Jose, AU - Choquette,Monique, AU - Hawkins,Jennifer, AU - Hoeper,Amy, AU - Bernstein,David I, AU - Cohen,Mitchell B, Y1 - 2014/11/19/ PY - 2014/11/21/entrez PY - 2014/11/21/pubmed PY - 2015/8/28/medline SP - 129 EP - 35 JF - Clinical and vaccine immunology : CVI JO - Clin. Vaccine Immunol. VL - 22 IS - 1 N2 - 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 ×10(7), 1 ×10(8), 1 ×10(9), and 1 ×10(10) 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(9)-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 ×10(10) 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.). SN - 1556-679X UR - https://www.unboundmedicine.com/medline/citation/25410205/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_ L2 - http://cvi.asm.org/cgi/pmidlookup?view=long&pmid=25410205 DB - PRIME DP - Unbound Medicine ER -