A Phase 3 Lot to Lot Consistency Study of Live Oral Cholera Vaccine, PXVX0200 in Healthy Adults
NCT ID: NCT02094586
Last Updated: 2023-06-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
3146 participants
INTERVENTIONAL
2014-05-31
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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PXVX0200 Lot A
PXVX0200 (Lot P700-1CA03) Single dose; liquid suspension after reconstitution with buffer; \> 2x10\^8 CFU in a liquid suspension
PXVX0200 Lot A
Lot P700-1CA03
PXVX0200 Lot B
PXVX0200 (Lot P700-3CA03) Single dose; liquid suspension after reconstitution with buffer; \> 2x10\^8 CFU in a liquid suspension
PXVX0200 Lot B
Lot P700-3CA03
PXVX0200 Lot C
PXVX0200 (Lot P700-6BA03) Single dose; liquid suspension after reconstitution with buffer; \> 2x10\^8 CFU in a liquid suspension
PXVX0200 Lot C
Lot P700-6BA03
Placebo
Placebo physiological saline
Placebo
Placebo
Interventions
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PXVX0200 Lot A
Lot P700-1CA03
PXVX0200 Lot B
Lot P700-3CA03
PXVX0200 Lot C
Lot P700-6BA03
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* age 18 to 45 years inclusive;
* normal medical history and physical examination
* Women must have a negative pregnancy test.
Exclusion Criteria
* abnormal stool pattern or regular use of laxatives;
* Currently active unstable or undiagnosed medical conditions
* current or recent antibiotic use;
* pregnancy or nursing;
* Previously received a licensed or investigational cholera vaccine
* History of cholera or enterotoxigenic E. coli infection
* History of Guillain-Barré Syndrome
* Received or plans to receive any other licensed vaccines, except for seasonal influenza
* Recipient of bone marrow or solid organ transplant
* Malignancy (excluding non-melanotic skin cancers) or lymphoproliferative disorders diagnosed or treated during the past 5 years
* Use of systemic chemotherapy in the previous 5 years prior to the study
* any immunosuppressive medical condition
18 Years
45 Years
ALL
Yes
Sponsors
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Emergent BioSolutions
INDUSTRY
Bavarian Nordic
INDUSTRY
Responsible Party
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Principal Investigators
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James McCarty, MD
Role: STUDY_DIRECTOR
Emergent Travel Health Inc.
Locations
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Coastal Clinical Research
Mobile, Alabama, United States
Clinical Reseach Consortium Arizona
Phoenix, Arizona, United States
Avail Clinical Research
DeLand, Florida, United States
Miami Research Associates
Miami, Florida, United States
Palm Beach Research
West Palm Beach, Florida, United States
Emory University
Atlanta, Georgia, United States
Johnson County Clin-Trials
Lenexa, Kansas, United States
Heartland Research Associates
Wichita, Kansas, United States
Central Kentucky Research
Lexington, Kentucky, United States
University of Kentucky
Lexington, Kentucky, United States
Boston University
Boston, Massachusetts, United States
Center for Pharmaceutical Research
Kansas City, Missouri, United States
St. Louis University
St Louis, Missouri, United States
Clinical Research Consortium Las Vegas
Las Vegas, Nevada, United States
Rochester Clinical Research
Rochester, New York, United States
Lion Research
Norman, Oklahoma, United States
Coastal Carolina Research
Mt. Pleasant, South Carolina, United States
Research Across America
Dallas, Texas, United States
Jean Brown Research
Salt Lake City, Utah, United States
QIMR Berghofer Medical Research Institiue
Herston, Queensland, Australia
AUS Trials Pty Ltd
Sherwood, Queensland, Australia
CMAX
Adelaide, South Australia, Australia
Emeritis Research
Malvern East, Victoria, Australia
Nucleus Network
Melbourne, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Countries
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References
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McCarty JM, Lock MD, Hunt KM, Simon JK, Gurwith M. Safety and immunogenicity of single-dose live oral cholera vaccine strain CVD 103-HgR in healthy adults age 18-45. Vaccine. 2018 Feb 1;36(6):833-840. doi: 10.1016/j.vaccine.2017.12.062. Epub 2018 Jan 6.
Other Identifiers
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PXVX-VC-200-004
Identifier Type: -
Identifier Source: org_study_id
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