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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
PaxVax, Inc.
ClinicalTrials.gov Identifier:
NCT02100631
First received: March 25, 2014
Last updated: September 2, 2014
Last verified: September 2014
  Purpose

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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of vaccinees with at least a 4-fold rise vibriocidal antibody [ Time Frame: up to 180 days after vaccination ] [ Designated as safety issue: No ]
  • number of subjects with serious and non serious adverse events [ Time Frame: following vaccination through 180 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: May 2014
Estimated Primary Completion Date: September 2014 (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

  Eligibility

Ages Eligible for Study:   46 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT02100631

Locations
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
University of Kentucky
Lexington, Kentucky, United States, 40536
Central Kentucky Research
Lexington, Kentucky, United States, 40509
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
Australia, Queensland
AUS Trials Pty Ltd
Sherwood, Queensland, Australia, 4035
Australia, Victoria
Emeritis Research
Malvern East, Victoria, Australia, 3145
Nucleus Network
Melbourne, Victoria, Australia, 3004
The University of Melbourne
Melbourne, Victoria, Australia, 3010
Sponsors and Collaborators
PaxVax, Inc.
  More Information

No publications provided

Responsible Party: PaxVax, Inc.
ClinicalTrials.gov Identifier: NCT02100631     History of Changes
Other Study ID Numbers: PXVX-VC-200-005
Study First Received: March 25, 2014
Last Updated: September 2, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 14, 2014