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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02100631
Recruitment Status : Completed
First Posted : April 1, 2014
Last Update Posted : July 16, 2015
Information provided by (Responsible Party):
PaxVax, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Cholera Biological: PXVX0200 Biological: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 398 participants
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
Study Start Date : May 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cholera
U.S. FDA Resources

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02100631

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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.

Responsible Party: PaxVax, Inc. Identifier: NCT02100631     History of Changes
Other Study ID Numbers: PXVX-VC-200-005
First Posted: April 1, 2014    Key Record Dates
Last Update Posted: July 16, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Vibrio Infections
Gram-Negative Bacterial Infections
Bacterial Infections