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

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.
 
ClinicalTrials.gov Identifier: NCT01895855
Recruitment Status : Completed
First Posted : July 11, 2013
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Emergent BioSolutions

Tracking Information
First Submitted Date  ICMJE July 5, 2013
First Posted Date  ICMJE July 11, 2013
Last Update Posted Date July 2, 2018
Study Start Date  ICMJE September 2013
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2013)
  • Ten day cholera challenge [ Time Frame: Ten days after vaccination ]
    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 ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2013)
  • disease severity [ Time Frame: from vaccination through day 180 ]
    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 ]
    Incidence and severity of signs and symptoms of reactogenicity such as diarrhea, and fever Incidence and severity of unsolicited adverse events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Challenge Study of Live Oral Cholera Vaccine Candidate,PXVX0200, to Prevent Cholera
Official Title  ICMJE 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
Brief Summary the purpose of the study is to determine if PXVX0200 is safe and effective in preventing cholera infection
Detailed Description The purpose of the study is to determine if PXVX0200 is safe and effective in preventing cholera infection
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Cholera
Intervention  ICMJE
  • Biological: PXVX0200
    Single dose; liquid suspension after reconstitution with buffer; 2x108 to 2x109 CFU in a liquid suspension
  • Biological: placebo
Study Arms  ICMJE
  • Experimental: PXVX0200
    Biological: PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 2x108 to 2x109 CFU in a liquid suspension
    Intervention: Biological: PXVX0200
  • Placebo Comparator: Placebo
    Biological: Placebo physiological saline
    Intervention: Biological: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 10, 2013)
210
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01895855
Other Study ID Numbers  ICMJE PXVX-VC-200-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Emergent BioSolutions
Study Sponsor  ICMJE Emergent BioSolutions
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sean Bennett, MD Emergent BioSolutions
PRS Account Emergent BioSolutions
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP