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

This study has been completed.
Information provided by (Responsible Party):
PaxVax, Inc. Identifier:
First received: March 25, 2014
Last updated: July 15, 2015
Last verified: July 2015
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.

Condition Intervention Phase
Cholera Biological: PXVX0200 Biological: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

Further study details as provided by PaxVax, Inc.:

Primary Outcome Measures:
  • Seroconversion by vibriocidal antibody (i.e., a 4-fold rise over baseline titer) [ Time Frame: up to 28 days following vaccination ]

Secondary Outcome Measures:
  • Percentage of vaccinees with at least a 4-fold rise vibriocidal antibody [ Time Frame: up to 180 days after vaccination ]
  • number of subjects with serious and non serious adverse events [ Time Frame: following vaccination through 180 days ]

Enrollment: 398
Study Start Date: May 2014
Study Completion Date: June 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PXVX0200
PXVX0200 Single dose; liquid suspension after reconstitution with buffer; > 2x108 CFU in a liquid suspension
Biological: PXVX0200
Placebo Comparator: Placebo
Placebo physiological saline
Biological: Placebo


Ages Eligible for Study:   46 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02100631

United States, Alabama
Coastal Clinical Research
Mobile, Alabama, United States, 36608
United States, Florida
Avail Clinical
Deland, Florida, United States, 32720
Miami Research Associates
Miami, Florida, United States, 33143
Palm Beach Research Center
Palm Beach, Florida, United States, 33409
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Kansas
Johnson County Clin-Trials
Lenexa, Kansas, United States, 66219
Heartland Research
Witchita, Kansas, United States, 67207
United States, Kentucky
Central Kentucky Research
Lexington, Kentucky, United States, 40509
University of Kentucky
Lexington, Kentucky, United States, 40536
United States, Massachusetts
Boston University
Boston, Massachusetts, United States, 02218
United States, Missouri
Center for Pharmaceutical Research
Kansas City, Missouri, United States, 64114
St. Louis University
St Louis, Missouri, United States, 63104
United States, South Carolina
Coastal Carolina Research
Mt. Pleasant, South Carolina, United States, 29464
United States, Texas
Research Across America
Dallas, Texas, United States, 75234
United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124
United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05405
Sponsors and Collaborators
PaxVax, Inc.
  More Information

Responsible Party: PaxVax, Inc. Identifier: NCT02100631     History of Changes
Other Study ID Numbers: PXVX-VC-200-005
Study First Received: March 25, 2014
Last Updated: July 15, 2015

Additional relevant MeSH terms:
Vibrio Infections
Gram-Negative Bacterial Infections
Bacterial Infections processed this record on September 19, 2017