A Study of Live Oral Cholera Vaccine, PXVX200 in Healthy Older Adults



Status:Completed
Conditions:Infectious Disease, Gastrointestinal
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases
Healthy:No
Age Range:46 - 64
Updated:4/21/2016
Start Date:May 2014
End Date:June 2015

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A Phase III Randomized, Double-blind, Placebo-controlled Study in Older Adults to Assess Immunogenicity and Clinical Acceptability of a Single-dose of the Live Oral Cholera Vaccine Candidate PXVX0200 Vibrio Cholerae O1 Serotype Inaba Vaccine Strain CVD 103-HgR

Demonstrate that the vaccine offers protection based on antibody levels in older adults and
is similar to antibody levels in adults aged 18-45 following vaccination with PXVX0200.


Inclusion Criteria:

- healthy men or women,

- age 46 to 64 years inclusive;

- normal medical history and physical examination

- Women must have a negative pregnancy test

Exclusion Criteria:

- travel to a cholera endemic area in the previous 5 years;

- 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
We found this trial at
16
sites
One Silber Way
Boston, Massachusetts 02215
(617) 353-2000
Boston University Boston University is no small operation . With over 33,000 undergraduate and graduate...
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Boston, MA
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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85 S Prospect St
Burlington, Vermont 5405
(802) 656-3131
University of Vermont The University of Vermont combines faculty-student relationships most commonly found in a...
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Burlington, VT
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1045 East 3900 South
Salt Lake City, Utah 84124
801-261-2000
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Dallas, Texas 75010
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Dallas, TX
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Deland, Florida 32720
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Deland, FL
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Kansas City, Missouri 64114
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Kansas City, MO
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Lenexa, Kansas 66219
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Lenexa, KS
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Lexington, Kentucky
859) 257-9000
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Lexington, KY
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Lexington, Kentucky 40509
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Miami, Florida
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Miami, FL
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Mobile, Alabama 36608
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Mobile, AL
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Mt. Pleasant, South Carolina 29464
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Mt. Pleasant, SC
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Palm Beach, Florida 33409
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Palm Beach, FL
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St Louis, Missouri 63220
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Witchita, Kansas 67207
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Witchita, KS
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