Safety and Efficacy Challenge Study of Live Oral Cholera Vaccine Candidate,PXVX0200, to Prevent Cholera

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
PaxVax, Inc.
ClinicalTrials.gov Identifier:
NCT01895855
First received: July 5, 2013
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

the purpose of the study is to determine if PXVX0200 is safe and effective in preventing cholera infection


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Efficacy Trial of a Single Dose Live Oral Cholera Vaccine, PXVX0200 CVD 103-HgR, in Preventing Cholera Following Challenge With Vibrio Cholerae 10 Days or 3 Months After Vaccination

Resource links provided by NLM:


Further study details as provided by PaxVax, Inc.:

Primary Outcome Measures:
  • Ten day cholera challenge [ Time Frame: Ten days after vaccination ] [ Designated as safety issue: No ]
    Determine whether a single dose of PXVX0200 provides significant protection against a challenge with virulent V. cholerae O1 El Tor Inaba at 10 days after vaccination.

  • Ninety day cholera challenge [ Time Frame: Ninety days after vaccination ] [ Designated as safety issue: No ]
    Determine whether a single dose of PXVX0200 provides significant protection against a challenge with virulent V. cholerae O1 El Tor Inaba at 3 months after vaccination.


Secondary Outcome Measures:
  • disease severity [ Time Frame: from vaccination through day 180 ] [ Designated as safety issue: No ]
    Total weight of diarrheal stools Incidence of diarrhea of any severity Incidence of fever Incidence of fecal shedding of wild type Vibrio cholerae Peak concentration of wild type Vibrio cholerae detected in stool

  • tolerability of vaccine [ Time Frame: following vaccination through 180 days ] [ Designated as safety issue: Yes ]
    Incidence and severity of signs and symptoms of reactogenicity such as diarrhea, and fever Incidence and severity of unsolicited adverse events


Estimated Enrollment: 210
Study Start Date: September 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PXVX0200
Biological: PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 2x108 to 2x109 CFU in a liquid suspension
Biological: PXVX0200
Single dose; liquid suspension after reconstitution with buffer; 2x108 to 2x109 CFU in a liquid suspension
Placebo Comparator: Placebo
Biological: Placebo physiological saline
Biological: placebo

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy men or women,
  • age 18 to 45 years inclusive;
  • normal medical history and physical examination; and
  • no clinically significant abnormalities from:

    • urine dipstick for glucose,
    • protein, and
    • blood,
    • complete blood count,
    • serum hepatic transaminases,
    • total bilirubin (direct if abnormal),
    • creatinine,
    • electrolytes,
    • albumin, or
    • electrocardiogram.
  • 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;
  • history of eating disorders (such as bulimia), anal or rectal disorders, allergy to tetracycline and/or ciprofloxacin;
  • history of cholera or enterotoxigenic E. coli challenge;
  • current or recent antibiotic use;
  • pregnancy or nursing;
  • positive serology for HIV, hepatitis B antigen, or hepatitis C;
  • any immunosuppressive medical condition;
  • history of hospitalization for psychiatric illness or use of specific psychiatric drugs.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01895855

Locations
United States, Maryland
University of Maryland Baltimore
Baltimore, Maryland, United States, 21201
United States, Ohio
Cincinnati Children'S Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05405
Sponsors and Collaborators
PaxVax, Inc.
  More Information

No publications provided

Responsible Party: PaxVax, Inc.
ClinicalTrials.gov Identifier: NCT01895855     History of Changes
Other Study ID Numbers: PXVX-VC-200-003
Study First Received: July 5, 2013
Last Updated: March 19, 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 April 17, 2014